125742 S1 M5 5351 c4591001 fa interim interlab standard
Document text
090177e194a3e5e4\Approved\Approved On: 29-Sep-2020 03:51 (GMT)
Page 1
FDA-CBER-2021-5683-1072171
090177e194a3e5e5\Approved\Approved On: 29-Sep-2020 03:51 (GMT)
Page 2
FDA-CBER-2021-5683-1072172
1
Project Sponsor Flags Technical 26 -MAY-20 02:26 PM
Page: 1
Project: 522472
Ages Paramenter Reach Value Negative Positive
Test Race Sex Low High Conventional SI Flag Conv SI Flag Conv SI Flag
Hy'sLaw2.2 Both 0Y 999Y
ADC4996=Criteria Criteria M HY
ADC7567=Potentia Potential H1
TB ALT Nrm Both 0Y 999Y ADC7008=G3 G3 G3
ADC7009=G2 G2 G2
ADC7010=G1 G1 G1
ADC7056=G4 G4 G4
TB AST Nrm Both 0Y 999Y
ADC7008=G3 G3 G3
ADC7009=G2 G2 G2
ADC7010=G1 G1 G1
ADC7056=G4 G4 G4
TB ALT Elv Both 0Y 999Y
ADC7008=G3 G3 G3
ADC7009=G2 G2 G2
ADC7010=G1 G1 G1
ADC7056=G4 G4 G4
TB AST Elv Both 0Y 999Y
ADC7008=G3 G3 G3
ADC7009=G2 G2 G2
ADC7010=G1 G1 G1
ADC7056=G4 G4 G4
Eosinophil Female 0D 4D >0.64 >0.64 G1
>1.50 >1.50 G2
>5.00 >5.00 G3
4D 8D >0.64 >0.64 G1
>1.50 >1.50 G2
>5.00 >5.00 G3
8D 15D >0.64 >0.64 G1
>1.50 >1.50 G2
>5.00 >5.00 G3
15D 31D >0.64 >0.64 G1
>1.50 >1.50 G2
>5.00 >5.00 G3
31D 61D >0.64 >0.64 G1
>1.50 >1.50 G2
>5.00 >5.00 G3
61D 180D >0.64 >0.64 G1
>1.50 >1.50 G2
>5.00 >5.00 G3
180D 2Y >0.64 >0.64 G1
>1.50 >1.50 G2
>5.00 >5.00 G3
2Y 6Y >0.64 >0.64 G1
090177e194a3e5e3\Approved\Approved On: 29-Sep-2020 03:51 (GMT)
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FDA-CBER-2021-5683-1072173
Project Sponsor Flags Technical 26 -MAY-20 02:26 PM
Page: 2
Project: 522472
C4591001 Continued Ages Paramenter Reach Valu e Negative Positive
Test Race Sex Low High Conventional SI Flag Conv SI Flag Conv SI Flag
Eosinophil Continued >1.50 >1.50 G2
>5.00 >5.00 G3
6Y 12Y >0.64 >0.64 G1
>1.50 >1.50 G2
>5.00 >5.00 G3
12Y 18Y >0.64 >0.64 G1
>1.50 >1.50 G2
>5.00 >5.00 G3
18Y 999Y >0.64 >0.64 G1
>1.50 >1.50 G2
>5.00 >5.00 G3
Male 0D 4D >0.64 >0.64 G1
>1.50 >1.50 G2
>5.00 >5.00 G3
4D 8D >0.64 >0.64 G1 >1.50 >1.50 G2
>5.00 >5.00 G3
8D 15D >0.64 >0.64 G1
>1.50 >1.50 G2
>5.00 >5.00 G3
15D 31D >0.64 >0.64 G1
>1.50 >1.50 G2
>5.00 >5.00 G3
31D 61D >0.64 >0.64 G1
>1.50 >1.50 G2
>5.00 >5.00 G3
61D 180D >0.64 >0.64 G1
>1.50 >1.50 G2
>5.00 >5.00 G3
180D 2Y >0.64 >0.64 G1
>1.50 >1.50 G2
>5.00 >5.00 G3
2Y 6Y >0.64 >0.64 G1
>1.50 >1.50 G2
>5.00 >5.00 G3
6Y 12Y >0.64 >0.64 G1
>1.50 >1.50 G2
>5.00 >5.00 G3
12Y 18Y >0.64 >0.64 G1
>1.50 >1.50 G2
>5.00 >5.00 G3
18Y 999Y >0.64 >0.64 G1
>1.50 >1.50 G2
>5.00 >5.00 G3
Platelets Female 0D 1D <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
1D 8D <25 <25 G4
<100 <100 G3
090177e194a3e5e3\Approved\Approved On: 29-Sep-2020 03:51 (GMT)
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FDA-CBER-2021-5683-1072174
Project Sponsor Flags Technical 26 -MAY-20 02:26 PM
Page: 3
Project: 522472
C4591001 Continued
Ages Paramenter Reach Value Negative Positive
Test Race Sex Low High Conventional SI Flag Conv SI Flag Conv SI Flag Platelets Continued <125 <125 G2
<141 <141 G1
8D 15D <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
15D 31D <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
31D 4M <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
4M 7M <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
7M 2Y <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
2Y 3Y <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
3Y 6Y <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
6Y 12Y <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
12Y 60Y <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
60Y 999Y <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
Male 0D 1D <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
1D 8D <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
8D 15D <25 <25 G4
090177e194a3e5e3\Approved\Approved On: 29-Sep-2020 03:51 (GMT)
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FDA-CBER-2021-5683-1072175
Project Sponsor Flags Technical 26 -MAY-20 02:26 PM
Page: 4
Project: 522472
C4591001 Continued Ages Paramenter Reach Value Negative Positive Test Race Sex Low High Conventional SI Flag Conv SI Flag Conv SI Flag
Platelets Continued <100 <100 G3
<125 <125 G2
<141 <141 G1
15D 31D <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
31D 4M <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
4M 7M <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
7M 2Y <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
2Y 3Y <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
3Y 6Y <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
6Y 12Y <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
12Y 60Y <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
60Y 999Y <25 <25 G4
<100 <100 G3
<125 <125 G2
<141 <141 G1
HGB Female 0D 1D <8.0 <80 G4
<9.5 <95 G3
<11.0 <110 G2
<12.1 <121 G1
1D 8D <8.0 <80 G4
<9.5 <95 G3
<11.0 <110 G2
<12.1 <121 G1
8D 15D <8.0 <80 G4
<9.5 <95 G3
<11.0 <110 G2
090177e194a3e5e3\Approved\Approved On: 29-Sep-2020 03:51 (GMT)
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FDA-CBER-2021-5683-1072176
Project Sponsor Flags Technical 26 -MAY-20 02:26 PM
Page: 5
Project: 522472
C4591001
Continued Ages Paramenter Reach Value Negative Positive
Test Race Sex Low High Conventional SI Flag Conv SI Flag Conv SI Flag
HGB Continued <12.1 <121 G1
15D 31D <8.0 <80 G4
<9.5 <95 G3
<11.0 <110 G2
<12.1 <121 G1
31D 4M <8.0 <80 G4
<9.5 <95 G3
<11.0 <110 G2
<12.1 <121 G1
4M 7M <8.0 <80 G4
<9.5 <95 G3
<11.0 <110 G2
<12.1 <121 G1
7M 2Y <8.0 <80 G4
<9.5 <95 G3
<11.0 <110 G2
<12.1 <121 G1
2Y 3Y <8.0 <80 G4
<9.5 <95 G3
<11.0 <110 G2
<12.1 <121 G1
3 Y 6Y <8.0 <80 G4
<9.5 <95 G3
<11.0 <110 G2
<12.1 <121 G1
6Y 12Y <8.0 <80 G4
<9.5 <95 G3
<11.0 <110 G2
<12.1 <121 G1
12Y 59Y <8.0 <80 G4
<9.5 <95 G3
<11.0 <110 G2
<12.1 <121 G1
59Y 999Y <8.0 <80 G4
<9.5 <95 G3
<11.0 <110 G2
<12.1 <121 G1
Male 0D 1D <8.5 <85 G4
<10.5 <105 G3
<12.5 <125 G2
<13.6 <136 G1
1D 8D <8.5 <85 G4
<10.5 <105 G3
<12.5 <125 G2
<13.6 <136 G1
8D 15D <8.5 <85 G4
<10.5 <105 G3
<12.5 <125 G2
<13.6 <136 G1
15D 31D <8.5 <85 G4
<10.5 <105 G3
090177e194a3e5e3\Approved\Approved On: 29-Sep-2020 03:51 (GMT)
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FDA-CBER-2021-5683-1072177
Project Sponsor Flags Technical 26 -MAY-20 02:26 PM
Page: 6
Project: 522472
C4591001 Continued
Ages Paramenter Reach Value Negative Positive
Test Race Sex Low High Conventional SI Flag Conv SI Flag Conv SI Flag
HGB Continued <12.5 <125 G2
<13.6 <136 G1
31D 4M <8.5 <85 G4
<10.5 <105 G3
<12.5 <125 G2
<13.6 <136 G1
4M 7M <8.5 <85 G4
<10.5 <105 G3
<12.5 <125 G2
<13.6 <136 G1
7M 2Y <8.5 <85 G4
<10.5 <105 G3
<12.5 <125 G2
<13.6 <136 G1
2Y 3Y <8.5 <85 G4
<10.5 <105 G3
<12.5 <125 G2
<13.6 <136 G1
3Y 6Y <8.5 <85 G4
<10.5 <105 G3
<12.5 <125 G2
<13.6 <136 G1
6Y 12Y <8.5 <85 G4
<10.5 <105 G3
<12.5 <125 G2
<13.6 <136 G1
12Y 59Y <8.5 <85 G4
<10.5 <105 G3
<12.5 <125 G2
<13.6 <136 G1
59Y 999Y <8.5 <85 G4
<10.5 <105 G3
<12.5 <125 G2
<13.6 <136 G1
WBC Female 0D 15D <1.00 <1.00 G4
<1.50 <1.50 G3
<2.50 <2.50 G2
<3.50 <3.50 G1
>10.79 >10.79 G1
>15.00 >15.00 G2
>20.00 >20.00 G3
>25.00 >25.00 G4
15D 31D <1.00 <1.00 G4
<1.50 <1.50 G3
<2.50 <2.50 G2
<3.50 <3.50 G1
>10.79 >10.79 G1
>15.00 >15.00 G2
>20.00 >20.00 G3
>25.00 >25.00 G4
090177e194a3e5e3\Approved\Approved On: 29-Sep-2020 03:51 (GMT)
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FDA-CBER-2021-5683-1072178
Project Sponsor Flags Technical 26 -MAY-20 02:26 PM
Page: 7
Project: 522472
C4591001 Continued Ages Paramenter Reach Value Negative Positive
Test Race Sex Low High Conventional SI Flag Conv SI Flag Conv SI Flag
WBC Continued 31D 61D <1.00 <1.00 G4
<1.50 <1.50 G3
<2.50 <2.50 G2
<3.50 <3.50 G1
>10.79 >10.79 G1
>15.00 >15.00 G2
>20.00 >20.00 G3
>25.00 >25.00 G4
61D 7M <1.00 <1.00 G4
<1.50 <1.50 G3
<2.50 <2.50 G2
<3.50 <3.50 G1
>10.79 >10.79 G1
>15.00 >15.00 G2
>20.00 >20.00 G3
>25.00 >25.00 G4
7M 2Y <1.00 <1.00 G4
<1.50 <1.50 G3
<2.50 <2.50 G2
<3.50 <3.50 G1
>10.79 >10.79 G1
>15.00 >15.00 G2
>20.00 >20.00 G3
>25.00 >25.00 G4
2Y 6Y <1.00 <1.00 G4
<1.50 <1.50 G3
<2.50 <2.50 G2
<3.50 <3.50 G1
>10.79 >10.79 G1
>15.00 >15.00 G2
>20.00 >20.00 G3
>25.00 >25.00 G4
6Y 12Y <1.00 <1.00 G4
<1.50 <1.50 G3
<2.50 <2.50 G2
<3.50 <3.50 G1
>10.79 >10.79 G1
>15.00 >15.00 G2
>20.00 >20.00 G3
>25.00 >25.00 G4
1 2Y 18Y <1.00 <1.00 G4
<1.50 <1.50 G3
<2.50 <2.50 G2
<3.50 <3.50 G1
>10.79 >10.79 G1
>15.00 >15.00 G2
>20.00 >20.00 G3
>25.00 >25.00 G4
18Y 59Y <1.00 <1.00 G4
<1.50 <1.50 G3
<2.50 <2.50 G2
090177e194a3e5e3\Approved\Approved On: 29-Sep-2020 03:51 (GMT)
Page 9
FDA-CBER-2021-5683-1072179
Project Sponsor Flags Technical 26 -MAY-20 02:26 PM
Page: 8
Project: 522472
C4591001 Continued Ages Paramenter Reach Value Negative Positive
Test Race Sex Low High Conventional SI Flag Conv SI Flag Conv SI Flag
WBC Continued <3.50 <3.50 G1
>10.79 >10.79 G1
>15.00 >15.00 G2
>20.00 >20.00 G3
>25.00 >25.00 G4
59Y 999Y <1.00 <1.00 G4
<1.50 <1.50 G3
<2.50 <2.50 G2
<3.50 <3.50 G1
>10.79 >10.79 G1
>15.00 >15.00 G2
>20.00 >20.00 G3
>25.00 >25.00 G4
Male 0D 15D <1.00 <1.00 G4
<1.50 <1.50 G3
<2.50 <2.50 G2
<3.50 <3.50 G1
>10.79 >10.79 G1
>15.00 >15.00 G2
>20.00 >20.00 G3
>25.00 >25.00 G4
15D 31D <1.00 <1.00 G4
<1.50 <1.50 G3
<2.50 <2.50 G2
<3.50 <3.50 G1
>10.79 >10.79 G1
>15.00 >15.00 G2
>20.00 >20.00 G3
>25.00 >25.00 G4
31D 61D <1.00 <1.00 G4
<1.50 <1.50 G3
<2.50 <2.50 G2
<3.50 <3.50 G1
>10.79 >10.79 G1
>15.00 >15.00 G2
>20.00 >20.00 G3
>25.00 >25.00 G4
61D 7M <1.00 <1.00 G4
<1.50 <1.50 G3
<2.50 <2.50 G2
<3.50 <3.50 G1
>10.79 >10.79 G1
>15.00 >15.00 G2
>20.00 >20.00 G3
>25.00 >25.00 G4
7M 2Y <1.00 <1.00 G4
<1.50 <1.50 G3
<2.50 <2.50 G2
<3.50 <3.50 G1
>10.79 >10.79 G1
>15.00 >15.00 G2
090177e194a3e5e3\Approved\Approved On: 29-Sep-2020 03:51 (GMT)
Page 10
FDA-CBER-2021-5683-1072180
Project Sponsor Flags Technical 26 -MAY-20 02:26 PM
Page: 9
Project: 522472
C4591001 Continued Ages Paramenter Reach Value Negative Positive
Test Race Sex Low High Conventional SI Flag Conv SI Flag Conv SI Flag
WBC Continued >20.00 >20.00 G3
>25.00 >25.00 G4
2Y 6Y <1.00 <1.00 G4
<1.50 <1.50 G3
<2.50 <2.50 G2
<3.50 <3.50 G1
>10.79 >10.79 G1
>15.00 >15.00 G2
>20.00 >20.00 G3
>25.00 >25.00 G4
6Y 12Y <1.00 <1.00 G4
<1.50 <1.50 G3
<2.50 <2.50 G2
<3.50 <3.50 G1
>10.79 >10.79 G1
>15.00 >15.00 G2
>20.00 >20.00 G3
>25.00 >25.00 G4
12Y 18Y <1.00 <1.00 G4
<1.50 <1.50 G3
<2.50 <2.50 G2
<3.50 <3.50 G1
>10.79 >10.79 G1
>15.00 >15.00 G2
>20.00 >20.00 G3
>25.00 >25.00 G4
18Y 59Y <1.00 <1.00 G4
<1.50 <1.50 G3
<2.50 <2.50 G2
<3.50 <3.50 G1
>10.79 >10.79 G1
>15.00 >15.00 G2
>20.00 >20.00 G3
>25.00 >25.00 G4
59Y 999Y <1.00 <1.00 G4
<1.50 <1.50 G3
<2.50 <2.50 G2
<3.50 <3.50 G1
>10.79 >10.79 G1
>15.00 >15.00 G2
>20.00 >20.00 G3
>25.00 >25.00 G4
Neutrophil Female 0D 1D <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
1D 8D <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
090177e194a3e5e3\Approved\Approved On: 29-Sep-2020 03:51 (GMT)
Page 11
FDA-CBER-2021-5683-1072181
Project Sponsor Flags Technical 26 -MAY-20 02:26 PM
Page: 10
Project: 522472
C4591001 Continued Ages Paramenter Reach Value Negative Positive
Test Race Sex Low High Conventional SI Flag Conv SI Flag Conv SI Flag
Neutrophil Continued 8D 15D <0.50 <0.50 G4 <1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
15D 31D <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
31D 4M <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
4M 7M <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
7M 2Y <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
2Y 3Y <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
3Y 6Y <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
6Y 12Y <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
12Y 18Y <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
18Y 59Y <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
59Y 999Y <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
Male 0D 1D <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
1D 8D <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
090177e194a3e5e3\Approved\Approved On: 29-Sep-2020 03:51 (GMT)
Page 12
FDA-CBER-2021-5683-1072182
Project Sponsor Flags Technical 26 -MAY-20 02:26 PM
Page: 11
Project: 522472
C4591001 Continued
Ages Paramenter Reach Value Negative Positive
Test Race Sex Low High Conventional SI Flag Conv SI Flag Conv SI Flag Neutrophil Continued <2.01 <2.01 G1
8D 15D <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
15D 31D <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
31D 4M <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
4M 7M <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
7M 2Y <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
2 Y 3Y <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
3Y 6Y <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
6Y 12Y <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
12Y 18Y <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
18Y 59Y <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
59Y 999Y <0.50 <0.50 G4
<1.00 <1.00 G3
<1.50 <1.50 G2
<2.01 <2.01 G1
Lymphocyte Female 0D 1D <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
1D 8D <0.25 <0.25 G4
090177e194a3e5e3\Approved\Approved On: 29-Sep-2020 03:51 (GMT)
Page 13
FDA-CBER-2021-5683-1072183
Project Sponsor Flags Technical 26 -MAY-20 02:26 PM
Page: 12
Project: 522472
C4591001 Continued Ages Paramenter Reach Value Negative Positive
Test Race Sex Low High Conventional SI Flag Conv SI Flag Conv SI Flag
Lymphocyte Continued <0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
8D 15D <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
15D 31D <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
31D 4M <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
4M 7M <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
7M 2Y <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
2Y 3Y <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
3Y 6Y <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
6Y 12Y <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
12Y 18Y <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
18Y 59Y <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
59Y 999Y <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
Male 0D 1D <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
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Page 14
FDA-CBER-2021-5683-1072184
Project Sponsor Flags Technical 26 -MAY-20 02:26 PM
Page: 13
Project: 522472
C4591001 Continued Ages Paramenter Reach Value Negative Positive
Test Race Sex Low High Conventional SI Flag Conv SI Flag Conv SI Flag
Lymphocyte Continued 1D 8D <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
8D 15D <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
15D 31D <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
31D 4M <0.25 <0.25 G4 <0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
4M 7M <0.25 <0.25 G4 <0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
7M 2Y <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
2Y 3Y <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
3Y 6Y <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
6Y 12Y <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
12Y 18Y <0.25 <0.25 G4 <0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
18Y 59Y <0.25 <0.25 G4 <0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
59Y 999Y <0.25 <0.25 G4
<0.50 <0.50 G3
<0.75 <0.75 G2
<1.01 <1.01 G1
Total Bili Both 0D 14D >12.8 >219 SF
>14.6 >250 SF
090177e194a3e5e3\Approved\Approved On: 29-Sep-2020 03:51 (GMT)
Page 15
FDA-CBER-2021-5683-1072185
Project Sponsor Flags Technical 26 -MAY-20 02:26 PM
Page: 14
Project: 522472
C4591001 Continued Ages Paramenter Reach Value Negative Positive
Test Race Sex Low High Conventional SI Flag Conv SI Flag Conv SI Flag
Total Bili Continued >17.6 >301 SF
>20.5 >351 SF
14D 18Y >1.2 >21 SF
>1.5 >26 SF
>1.8 >31 SF
>2.1 >36 SF
18Y 999Y >1.2 >21 SF
>1.5 >26 SF
>1.8 >31 SF
>2.1 >36 SF
ALT (SGPT) Female 0Y 1Y >58 >58 G1
>135 >135 G2
>270 >270 G3
>540 >540 G4
1Y 4Y >36 >36 G1
>85 >85 G2
>170 >170 G3
>340 >340 G4
4Y 7Y >36 >36 G1
>85 >85 G2
>170 >170 G3
>340 >340 G4
7Y 10Y >36 >36 G1
>85 >85 G2
>170 >170 G3
>340 >340 G4
10Y 18Y >36 >36 G1
>85 >85 G2
>170 >170 G3
>340 >340 G4
18Y 999Y >46 >46 G1
>108 >108 G2
>215 >215 G3
>430 >430 G4
Male 0Y 1Y >58 >58 G1
>135 >135 G2
>270 >270 G3
>540 >540 G4
1Y 4Y >36 >36 G1
>85 >85 G2
>170 >170 G3
>340 >340 G4
4Y 7Y >36 >36 G1
>85 >85 G2
>170 >170 G3
>340 >340 G4
7Y 10Y >36 >36 G1
>85 >85 G2
>170 >170 G3
>340 >340 G4
090177e194a3e5e3\Approved\Approved On: 29-Sep-2020 03:51 (GMT)
Page 16
FDA-CBER-2021-5683-1072186
Project Sponsor Flags Technical 26 -MAY-20 02:26 PM
Page: 15
Projec t: 522472
C4591001 Continued Ages Paramenter Reach Value Negative Positive
Test Race Sex Low High Conventional SI Flag Conv SI Flag Conv SI Flag
ALT (SGPT) Continued 10Y 18Y >46 >46 G1
>108 >108 G2
>215 >215 G3
>430 >430 G4
18Y 999Y >52 >52 G1
>120 >120 G2
>240 >240 G3
>480 >480 G4
Creatinine Female 0M 1M >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
1M 1Y >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
1Y 4Y >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
4Y 7Y >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
7Y 10Y >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
10Y 13Y >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
13Y 16Y >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
16Y 18Y >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
18Y 50Y >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
50Y 70Y >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
70Y 80Y >1.49 >132 G1
>1.70 >150 G2
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Page 17
FDA-CBER-2021-5683-1072187
Project Sponsor Flags Technical 26 -MAY-20 02:26 PM
Page: 16
Project: 522472
C4591001 Continued Ages Paramenter Reach Value Negative Positive
Test Race Sex Low High Conventional SI Flag Conv SI Flag Conv SI Flag
Creatinine Continued >2.00 >177 G3
>2.50 >221 G4
80Y 999Y >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
Male 0M 1M >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
1M 1Y >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
1Y 4Y >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
4Y 7Y >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
7Y 10Y >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
10Y 13Y >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
13Y 16Y >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
16Y 18Y >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
18Y 50Y >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
50Y 70Y >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
70Y 80Y >1.49 >132 G1
>1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
80Y 999Y >1.49 >132 G1
090177e194a3e5e3\Approved\Approved On: 29-Sep-2020 03:51 (GMT)
Page 18
FDA-CBER-2021-5683-1072188
Project Sponsor Flags Technical 26 -MAY-20 02:26 PM
Page: 17
Project: 522472
C4591001 Continued
Ages Paramenter Reach Value Negative Positive
Test Race Sex Low High Conventional SI Flag Conv SI Flag Conv SI Flag
Creatinine Continued >1.70 >150 G2
>2.00 >177 G3
>2.50 >221 G4
Alk Phos Female 0D 15D >272 >272 G1
>496 >496 G2
>744 >744 G3
>2480 >2480 G4
15D 1Y >515 >515 G1
>938 >938 G2
>1407 >1407 G3
>4690 >4690 G4
1Y 10Y >368 >368 G1
>670 >670 G2
>1005 >1005 G3
>3350 >3350 G4
10Y 13Y >458 >458 G1
>834 >834 G2
>1251 >1251 G3
>4170 >4170 G4
13Y 15Y >278 >278 G1
>508 >508 G2
>762 >762 G3
>2540 >2540 G4
15Y 17Y >128 >128 G1
>234 >234 G2
>351 >351 G3
>1170 >1170 G4
17Y 19Y >95 >95 G1
>174 >174 G2
>261 >261 G3
>870 >870 G4
19Y 999Y >113 >113 G1
>208 >208 G2
>312 >312 G3
>1040 >1040 G4
Male 0D 15D >272 >2 72 G1
>496 >496 G2
>744 >744 G3
>2480 >2480 G4
15D 1Y >515 >515 G1
>938 >938 G2
>1407 >1407 G3
>4690 >4690 G4
1Y 10Y >368 >368 G1
>670 >670 G2
>1005 >1005 G3
>3350 >3350 G4
10Y 13Y >458 >458 G1
>834 >834 G2
>1251 >1251 G3
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FDA-CBER-2021-5683-1072189
Project Sponsor Flags Technical 26 -MAY-20 02:26 PM
Page: 18 Project: 522472
C4591001 Continued Ages Paramenter Reach Value Negative Positive
Test Race Sex Low High Conventional SI Flag Conv SI Flag Conv SI Flag
Alk Phos Continued >4170 >4170 G4
13Y 15Y >514 >514 G1
>936 >936 G2
>1404 >1404 G3
>4680 >4680 G4
15Y 17Y >363 >363 G1
>662 >662 G2
>993 >993 G3
>3310 >3310 G4
17Y 19Y >163 >163 G1
>298 >298 G2
>447 >447 G3
>1490 >1490 G4
19Y 999Y >141 >141 G1
>258 >258 G2
>387 >387 G3
>1290 >1290 G4
AST (SGOT) Female 0Y 1Y >87 >87 G1
>200 >200 G2
>400 >400 G3
>800 >800 G4
1Y 4Y >61 >61 G1
>140 >140 G2
>280 >280 G3
>560 >560 G4
4Y 7Y >52 >52 G1
>120 >120 G2
>240 >240 G3
>480 >480 G4
7Y 18Y >43 >43 G1
>100 >100 G2
>200 >200 G3
>400 >400 G4
18Y 999Y >43 >43 G1
>100 >100 G2
>200 >200 G3
>400 >400 G4
Male 0Y 1Y >87 >87 G1
>200 >200 G2
>400 >400 G3
>800 >800 G4
1Y 4Y >75 >75 G1
>173 >173 G2
>345 >345 G3
>690 >690 G4
4Y 7Y >64 >64 G1
>148 >148 G2
>295 >295 G3
>590 >590 G4
7Y 18Y >43 >43 G1
090177e194a3e5e3\Approved\Approved On: 29-Sep-2020 03:51 (GMT)
Page 20
FDA-CBER-2021-5683-1072190
Project Sponsor Flags Technical 26 -MAY-20 02:26 PM
Page: 19
Project: 522472
C4591001 Continued Ages Paramenter Reach Value Negative Positive
Test Race Sex Low High Conventional SI Flag Conv SI Flag Conv SI Flag
AST (SGOT) Continued >100 >100 G2
>200 >200 G3
>400 >400 G4
18Y 999Y >43 >43 G1
>100 >100 G2
>200 >200 G3
>400 >400 G4
Urea Nitr Both 0Y 18Y >22 >8.0 G1
>26 >9.4 G2
>31 >11.2 G3
18Y 70Y >22 >8.0 G1
>26 >9.4 G2
>31 >11.2 G3
70Y 80Y >22 >8.0 G1
>26 >9.4 G2
>31 >11.2 G3
80Y 999Y >22 >8.0 G1
>26 >9.4 G2
>31 >11.2 G3
Flags: G1 Toxicity Grade 1
G2 Toxicity Grade 2
G3 Toxicity Grade 3
G4 Toxicity Grade 4
H1 Sponsor Flag
HY Hy's Law SF Sponsor Flag
19
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Page 21
FDA-CBER-2021-5683-1072191
Protocol C4591001
16.1. 10List of Labora tories
Page 1
CONFIDE NTIALList of La boratories – Final Analysis Interim
Organization Address Service (s)Provided
Pfizer Vaccine Research &
Development401 N Middletow n Road
Pearl River, NY 1 0965
USAS1-binding IgG level assay ;
RBD -binding IgG level assay ;
N-binding antibody assay; and
RT-PCR on nasal swabs for
SAR S-CoV-2.
Pfizer Vaccine Research &
Developmenta111 Ideation Way
Nutley, NJ 07110
USASARS -CoV- 2 neutralizati on
assay -NT50 and NT90 .
University of Texas Medica l
Bran chbDepartment of Biochemistry &
Molecular Bi ology
University of Texas Medical
Branch
Galveston, TX 77555 -1055
USASAR S-CoV- 2 neutralization
assay -NT50 and NT90 .
Covance Central Laboratory
Services8211 SciCor Drive
Indianapolis, IN 46214
USAPhase 1 Safety Labs:
hematologypanel (hemoglobin,
complete blood count with
diffe rential, and platelet s);
blood chemistry (ALT , AST ,
alkali nephosphat ase, total
bilirubin, BUN , and creatinine ).
Phase 1 Screening Labs:HIV,
HBsAg, HBc Ab, and HCV Ab.
Abbre viations : ALT = alan ineaminotransfe rase;AST = aspartat e aminotransferase ;BUN = blood
urea nitrogen ; HBcAb = hepatitis B core antibody; HBsAg =hepatitis B surface antigen;
HCV Ab=hepatitis C virus anti body ;HIV = human immunodeficien cy virus ; IgG = i mmuno globul in
G; N = SARS -CoV-2 nucleoprotein ;NT50= 50% neutraliz ingtiter; NT9 0 = 9 0%neutraliz ingtiter;
RBD = receptor -binding domain ;RT-PCR =reverse transcription –polymerase chain reaction ;
S1 = s pike proteinS1subun it;SAR S-CoV-2 = severe a cute r espiratory syndrome corona virus 2 .
a. Pfizer Vaccine R esearch & Development , Nutley, NJ,performe d the neutral ization assays for
Phase 2/3.
b. The University of Texas Medical Branch, Galveston ,TX,perform edthe neutral ization assays for
Phase 1.
Protoco l C4591001 Listof Laboratories –Final Analysis Interim ,Final, Version1.0, 20Nov 2020 .
090177e195946ee4\Final\Final On: 20-Nov-2020 19:58 (GMT)
Page 22
(b) (4), (b) (6)
FDA-CBER-2021-5683-1072192