A5418: 31985 Socios En Salud Sucursal Perú CRS

DRAFT
IND Study: Yes
MiPAL Version: 0.2 Completed by: (Maria) Cecilia Chang-
Letter of Amendment: Ching, Roger Calderon, Carmen
Clarification Memo: Salinas
Submitted: 3/3/2023
LC Reviewer: Jade Paris
Date MiPAL First Checked by DCLOT:
DCLOT First Reviewer:
Date MiPAL Checked by DCLOT:
DCLOT Reviewer:
Lab Instrument Instrument Instrument Instrument US FDA CE Marked Method/Kit Name Method/Kit Method US FDA CE Marked External EQA
Name Manufacturer Model Number Serial Number Approved Manufacturer Product Code Approved EQA Panel
Provider Details

Chemistry

Primary HID0218 - Vitros Ortho Clinical 250/350 25011588 Yes Yes BGC / ALB Ortho Clinical 1986211 Yes Yes CAP C
Impacta Diagnostics Diagnostics 198 8211
Barranco
Laboratory
Albumin
Backup HID0005 - Cobas 6000 - Roche 15S9 - 10 1178-17 Yes Yes COBAS INTEGRA Roche Diagnostics 03183688122 Yes Yes CAP C
ANGLO Cobas C501 SYSTEM Test ALB2

Primary HID0218 - Vitros Ortho Clinical 250/350 25011588 Yes Yes VITROS Chemistry Ortho Clinical 105 3180 Yes Yes CAP C
Impacta Diagnostics Products ALKP Diagnostics
Barranco Slides
Laboratory
Alkaline
Phosphatase Roche Diagnostics Yes Yes CAP C
Backup HID0005 - Cobas 6000 - Roche 15S9 - 10 1178-17 Yes Yes COBAS INTEGRA 03333752 190
ANGLO Cobas C501 SYSTEM ALP

Primary HID0218 - Vitros Ortho Clinical 250/350 25011588 Yes Yes VITROS Chemistry Ortho Clinical 161 2365 Yes Yes CAP C
Impacta Diagnostics Products BuBc Diagnostics
Barranco Slides
Laboratory
Bilirubin,
direct Roche Diagnostics Yes Yes CAP C
Backup HID0005 - Cobas 6000 - Roche 15S9 - 10 1178-17 Yes Yes COBAS INTEGRA 03146022 122
ANGLO Cobas C501 SYSTEM Bilirubin
Direct

Primary HID0218 - Vitros Ortho Clinical 250/350 25011588 Yes Yes Vitros Chemistry Ortho Clinical 8159931 Yes Yes CAP C
Impacta Diagnostics Products TBIL Slides Diagnostics
Barranco
Laboratory
Bilirubin,
total Roche Diagnostics Yes Yes CAP C
Backup HID0005 - Cobas 6000 - Roche 15S9 - 10 1178-17 Yes Yes COBAS INTEGRA 05 795 397 190
ANGLO Cobas C501 SYSTEM Bilirubin
Total Gen.3

1
 Lab Instrument Instrument Instrument Instrument US FDA CE Marked Method/Kit Name Method/Kit Method US FDA CE Marked External EQA
Name Manufacturer Model Serial Number Approved Manufacturer Product Code Approved EQA Panel
Number Provider Details
Primary HID0218 - Vitros Ortho Clinical 250/350 25011588 Yes Yes Vitros Chemistry Ortho Clinical 6802584 Yes Yes CAP C
Impacta Diagnostics Products CREA Diagnostics
Barranco /IDMS Slides
Laboratory
Creatinine
Backup HID0005 - Cobas 6000 - Roche 15S9 - 10 1178-17 Yes Yes COBAS INTEGRA Roche Diagnostics 04810716 190 Yes Yes CAP C
ANGLO Cobas C501 SYSTEM Creatinine
Jaffé Gen.2

Primary HID0218 - Vitros Ortho Clinical 250/350 25011588 Yes Yes ISE Undiluted/Vitros Ortho Clinical 8157596 Yes Yes CAP C
Impacta Diagnostics Chemistry Products Diagnostics
Barranco K Slides
Laboratory
Potassium
Backup HID0005 - Electrolytes i-Sens Inc. I-SMART 30 Yes Yes i- Smart 30 PRO i-Sens Inc. 6414 Yes Yes CAP C
ANGLO Analyzer I-Smart PRO Cartridge (Na+, K+,
30 Pro Cl-)

Primary HID0218 - Vitros Ortho Clinical 250/350 25011588 Yes Yes Vitros Chemistry Ortho Clinical 839 2292 Yes Yes CAP C
Impacta Diagnostics Products TP Slides Diagnostics
Barranco
Laboratory
Protein, total
Backup HID0005 - Cobas 6000 - Roche 15S9 - 10 1178-17 Yes Yes COBAS INTEGRA Roche Diagnostics 03183734 190 Yes Yes CAP C
ANGLO Cobas C501 SYSTEM Total
Protein

Primary HID0218 - Vitros Ortho Clinical 250/350 25011588 Yes Yes VITROS Chemistry Ortho Clinical 8379034 Yes Yes CAP C
Impacta Diagnostics Products Na+ Slides Diagnostic
Barranco
Laboratory
Sodium
Backup HID0005 - Electrolytes i-Sens Inc. I-SMART 30 Yes Yes i- Smart 30 PRO i-Sens Inc. 6414 Yes Yes CAP C
ANGLO Analyzer I-Smart PRO Cartridge (Na+, K+,
30 Pro Cl-)

Primary HID0218 - Vitros Ortho Clinical 250/350 25011588 Yes Yes VITROS Chemistry Ortho Clinical 810 2204 Yes Yes CAP C
Impacta Diagnostics Products BUN/UREA Diagnostics
Barranco Slides
Laboratory
Urea
Nitrogen
(BUN) Backup HID0005 - Cobas 6000 - Roche 15S9 - 10 1178-17 Yes Yes UREAL Roche Diagnostics 4460715190 Yes Yes CAP C
ANGLO Cobas C501

Primary HID0218 - Vitros Ortho Clinical 250/350 25011588 Yes Yes VITROS Chemistry Ortho Clinical 684 4288 Yes Yes CAP C
Impacta Diagnostics Products ALTV Diagnostics
Barranco
Laboratory
ALT
Backup HID0005 - Cobas 6000 - Roche 15S9 - 10 1178-17 Yes Yes COBAS INTEGRA Roche Diagnostics 20764957 322 Yes Yes CAP C
ANGLO Cobas C501 SYSTEM Alanine
Aminotransferase
(ALTL) Test

Primary HID0218 - Vitros Ortho Clinical 250/350 25011588 Yes Yes IFCC Vitros Ortho Clinical 8433815 Yes Yes CAP C
Impacta Diagnostics Chemistry Products Diagnostics
Barranco AST Slides
Laboratory
AST
Backup HID0005 - Cobas 6000 - Roche 15S9 - 10 1178-17 Yes Yes COBAS INTEGRA Roche Diagnostics 20764949 322 Yes Yes CAP C
ANGLO Cobas C501 SYSTEM Aspartate
Aminotransferase
(ASTL) Test

2
 Lab Instrument Instrument Instrument Instrument US FDA CE Marked Method/Kit Name Method/Kit Method US FDA CE Marked External EQA
Name Manufacturer Model Serial Number Approved Manufacturer Product Code Approved EQA Panel
Number Provider Details

CT/NG

Primary HID0141 - GENEXPERT IV CEPHEID GXIV-4N-6 707106 No Yes XPERT CT / NG CEPHEID EUROPE GXCT/NG-CE No Yes CAP HC7
Impacta San -4 EUROPE SAS SAS -10
Miguel
Laboratory
Chlamydia/G
C Screen,
Urine Backup HID0141 - GENEXPERT IV CEPHEID R2 4 110003895 No Yes XPERT CT / NG CEPHEID EUROPE GXCT/NG-CE No Yes CAP HC7
Impacta San -4 EUROPE SAS MÓDULOS SAS -10
Miguel 10C
Laboratory

Primary HID0141 - GENEXPERT IV CEPHEID GXIV-4N-6 707106 No Yes XPERT CT / NG CEPHEID EUROPE GXCT/NG-CE No Yes CAP HC7
Impacta San -4 EUROPE SAS SAS -10
Miguel
Laboratory
Chlamydia/G
C Screen,
Swab Backup HID0141 - GENEXPERT IV CEPHEID R2 4 110003895 No Yes XPERT CT / NG CEPHEID EUROPE GXCT/NG-CE No Yes CAP HC7
Impacta San -4 EUROPE SAS MÓDULOS SAS -10
Miguel 10C
Laboratory

Hematology

Primary HID0218 - PENTRA 60 C+ Horiba ABX Pentra 60 505PCP1341 Yes Yes ABX Diluent Horiba HO901020 Yes Yes CAP FH10
Impacta C+ 5
Barranco
Laboratory
Hematocrit
Backup HID0005 - XN 1000 SYSMEX XN-1000 29919 Yes Yes Cell Pack ROCHE ZA001393 Yes Yes CAP FH9
ANGLO Hematology
Analyzer

Primary HID0218 - PENTRA 60 C+ Horiba ABX Pentra 60 505PCP1341 Yes Yes ABX Diluent Horiba HO901020 Yes Yes CAP FH10
Impacta C+ 5
Barranco
Laboratory
Hemoglobin
Backup HID0005 - XN 1000 SYSMEX XN-1000 29919 Yes Yes Cell Pack ROCHE ZA001393 Yes Yes CAP FH9
ANGLO Hematology
Analyzer

Primary HID0218 - PENTRA 60 C+ Horiba ABX Pentra 60 505PCP1341 Yes Yes ABX Diluent Horiba HO901020 Yes Yes CAP FH10
Impacta C+ 5
Barranco
Laboratory
Platelet
Count ROCHE Yes Yes CAP FH9
Backup HID0005 - XN 1000 SYSMEX XN-1000 29919 Yes Yes Cell Pack ZA001393
ANGLO Hematology
Analyzer

Primary HID0218 - PENTRA 60 C+ Horiba ABX Pentra 60 505PCP1341 Yes Yes ABX Diluent Horiba HO901020 Yes Yes CAP FH10
Impacta C+ 5
Barranco
Laboratory
RBC
Backup HID0005 - XN 1000 SYSMEX XN-1000 29919 Yes Yes Cell Pack ROCHE ZA001393 Yes Yes CAP FH9
ANGLO Hematology
Analyzer

Primary HID0218 - PENTRA 60 C+ Horiba ABX Pentra 60 505PCP1341 Yes Yes ABX Diluent Horiba HO901020 Yes Yes CAP FH10
Impacta C+ 5
Barranco
Laboratory
WBC
Backup HID0005 - XN 1000 SYSMEX XN-1000 29919 Yes Yes Cell Pack ROCHE ZA001393 Yes Yes CAP FH9
ANGLO Hematology
Analyzer

3
 Lab Instrument Instrument Instrument Instrument US FDA CE Marked Method/Kit Name Method/Kit Method US FDA CE Marked External EQA
Name Manufacturer Model Serial Number Approved Manufacturer Product Code Approved EQA Panel
Number Provider Details
Primary HID0218 - PENTRA 60 C+ Horiba ABX Pentra 60 505PCP1341 Yes Yes ABX Diluent Horiba HO901020 Yes Yes CAP FH10
Impacta C+ 5
Barranco
Laboratory
WBC
Differential ROCHE Yes Yes CAP FH9
Backup HID0005 - XN 1000 SYSMEX XN-1000 29919 Yes Yes Cell Pack ZA001393
ANGLO Hematology
Analyzer

Hepatitis Viral Load

Primary HID0308 - U CAP/CLIA - N/A N/A N/A

Washington operating under
Retrovirus US lab
Lab requirements
HCV RNA
Backup N/A N/A N/A

Immunology

Primary N/A N/A N/A

hCG, serum,
qual - hCG,
serum, quant Backup N/A N/A N/A

IQA

Primary HID0218 - Flow Citometer / BD BD Facscount 337858 Yes Yes Flow Citometry / BD BD Biosciences 340167 Yes Yes UK 6x/yr
Impacta BD Facscount Biosciencies Facscount reagent NEQAS
Barranco
Laboratory
CD4
(absolute) BD Biosciences Yes Yes UK 6x/yr
Backup HID0218 - Flow Cytometer BD FACSCanto II V3389620253 Yes Yes BD FACS 7-color 335775
Impacta Biosciences 5 Setup Beads NEQAS
Barranco
Laboratory

Pharmacology

Primary Alturas NA NA

Intensive PK
Backup Alturas NA NA

Rapid HIV

Primary N/A N/A N/A

Anti-HIV-1
Backup N/A N/A N/A

4
 Lab Instrument Instrument Instrument Instrument US FDA CE Marked Method/Kit Name Method/Kit Method US FDA CE Marked External EQA
Name Manufacturer Model Serial Number Approved Manufacturer Product Code Approved EQA Panel
Number Provider Details
Primary HID0218 - Manual Method N/A N/A N/A N/A N/A ORAQUICK Orasure 3001-1197 Yes Yes OWA RVSS
Impacta ADVANCE Rapid 435
Barranco HIV 1/2 Antibody
Laboratory Test
Anti-HIV-1/2
Backup HID0141 - Manual Method N/A N/A N/A N/A N/A ORAQUICK Orasure 3001-1197 Yes Yes OWA RVSS
Impacta San ADVANCE Rapid 435
Miguel HIV 1/2 Antibody
Laboratory Test

Primary N/A N/A N/A

Anti-HIV
-1/2/P24
Backup N/A N/A N/A

Primary HID0218 - Geenius System BIORAD 94236 DP6A006909 Yes Yes Geenius HIV 1/2 BIORAD 72460 No Yes OWA RVSS
Impacta confirmatory assay 435
Barranco
Laboratory
Rapid
Confirmatory
Backup N/A N/A N/A

Specialty

Primary UWDLM- NA NA
Virology

MPX Virus
Backup UWDLM- NA NA
Virology

Storage

Primary HID0318 - N/A N/A

SES Peru

Urine
Storage
Backup N/A N/A N/A

Primary HID0318 - N/A N/A

SES Peru

Breast Milk
Storage
Backup N/A N/A N/A

Primary HID0318 - N/A N/A

SES Peru

Semen
Backup N/A N/A N/A

5
 Lab Instrument Instrument Instrument Instrument US FDA CE Marked Method/Kit Name Method/Kit Method US FDA CE Marked External EQA
Name Manufacturer Model Serial Number Approved Manufacturer Product Code Approved EQA Panel
Number Provider Details
Primary HID0318 - N/A N/A
SES Peru

Ocular Fluid
Backup N/A N/A N/A

Primary HID0318 - N/A N/A

SES Peru

PK sample
storage
Backup N/A N/A N/A

Primary HID0318 - N/A N/A

SES Peru

Serum
Storage
Backup N/A N/A N/A

Primary HID0318 - N/A N/A

SES Peru

Plasma
Storage
Backup N/A N/A N/A

Primary HID0218 - N/A N/A

Impacta
Barranco
Laboratory
PBMCs
Viable
Backup N/A N/A N/A

Primary HID0318 - N/A N/A

SES Peru

DBS Storage
Backup N/A N/A N/A

Syphilis

Primary HID0005 - Architect i1000 Abbott i1000 115r53016 Yes Yes CMIA Syphilis PT ABBOTT 8d06-29 Yes Yes CAP G
ANGLO

Syphilis,
Confirmatory
testing Backup N/A N/A N/A

6
 Lab Instrument Instrument Instrument Instrument US FDA CE Marked Method/Kit Name Method/Kit Method US FDA CE Marked External EQA
Name Manufacturer Model Serial Number Approved Manufacturer Product Code Approved EQA Panel
Number Provider Details
Primary HID0218 - Manual Method N/A N/A N/A N/A N/A RPR Quicktest Stanbio 1170-500 No Yes CAP G
Impacta
Barranco
Laboratory
Syphilis
Screen Stanbio No Yes CAP G
Backup HID0141 - Manual Method N/A N/A N/A N/A N/A RPR Quicktest 1170-500
Impacta San
Miguel
Laboratory

Urinalysis/Clinical Microscopy

Primary HID0218 - Manual Method N/A N/A N/A N/A N/A ONE-STEP TECO P597-A Yes Yes CAP CM
Impacta DIPSTICK DIAGNOSTICS
Barranco PREGNANCY TEST
Laboratory
hCG, urine
Backup HID0141 - Manual Method N/A N/A N/A N/A N/A ONE-STEP TECO P597-A Yes Yes CAP CM
Impacta San DIPSTICK DIAGNOSTICS
Miguel PREGNANCY
Laboratory TEST

Viral Markers

Primary HID0005 - Architect i1000 Abbott i1000 115r53016 Yes Yes ARC ANTI-HBC II Abbott Diagnostics 8L4425 Yes Yes CAP VM
ANGLO RGT

Anti-HBc
(Total) Roche Yes Yes CAP VM
Backup HID0005 - COBAS Roche E411 16F207 Yes Yes Anti HBc 11820559122
ANGLO

Primary HID0005 - Architect i1000 Abbott i1000 115r53016 Yes Yes ARC ANTI-HBS RGT Abbott Diagnostics 7C1825 Yes Yes CAP VM
ANGLO

Anti-HBs
Backup HID0005 - COBAS Roche E411 16F207 Yes Yes Anti HBs Roche 11820524122 Yes Yes CAP VM
ANGLO

Primary HID0005 - Architect i1000 Abbott i1000 115r53016 Yes Yes Architect Anti HCV Abbott Diagnostics 6C37 No Yes CAP VM
ANGLO

Anti-HCV
Backup HID0005 - COBAS Roche E411 16F207 Yes Yes COBAS Anti HCV Roche Diagnostics 03290352 160 Yes Yes CAP VM
ANGLO

Primary HID0005 - Architect i1000 Abbott i1000 115r53016 Yes Yes ARC HBSAG Abbott Diagnostics 1P9725 Yes Yes CAP VM
ANGLO QUALITATIVE RGT

HBsAg
Backup HID0005 - COBAS Roche E411 16F207 Yes Yes HBsAg G2 Roche 4687787190 Yes Yes CAP VM
ANGLO

Primary N/A N/A N/A

Anti-HIV-1
WB Proteins
- Western
Blot Backup N/A N/A N/A

7
 Lab Instrument Instrument Instrument Instrument US FDA CE Marked Method/Kit Name Method/Kit Method US FDA CE Marked External EQA
Name Manufacturer Model Serial Number Approved Manufacturer Product Code Approved EQA Panel
Number Provider Details
Primary HID0218 - ELISA microplate BIORAD PR4100 1601005176 Yes Yes GS HIV Combo BIORAD 26217 Yes No CAP VM
Impacta reader Ag/Ab EIA
Barranco
Laboratory
Anti-HIV
-1/2/P24 Abbott Diagnostics No Yes CAP VM
Backup HID0005 - Architect i1000 Abbott i1000 115r53016 Yes Yes ARCHITECT HIV 4J27-27
ANGLO Ag/Ab Combo

Primary N/A N/A N/A

Anti-HIV-1/2,
EIA
Backup N/A N/A N/A

Virology

Primary HID0308 - U CAP/CLIA - N/A N/A N/A

Washington operating under
Retrovirus US lab
Lab requirements
HSV
Backup N/A N/A N/A

Primary HID0318 - GeneXpert IV-4 Cepheid GXIV-4N-6 821584 / No Yes Xpert HIV-1 Viral Cepheid GXHIV-QA-CE No Yes N/A N/A
SES Peru Europa SAS 820837 Load -10

HIV NAT
Backup N/A N/A N/A

Primary HID0218 - Abbott m2000 rt Abbott m2000 rt 275020103 Yes Yes Abbott RealTime HIV Abbott 51-602146/R2 Yes Yes VQA HIV
Impacta -1 Amplification RNA
Barranco Reagent Kit
Laboratory
HIV RNA
Backup HID0141 - GENEXPERT IV CEPHEID GXIV-4N-6 707106 No Yes PCR / GX10 Test CEPHEID EUROPE GXHIV-VL-CE No Yes VQA HIV
Impacta San -4 EUROPE SAS HIV-1 Quant CE- SAS -10 RNA
Miguel IVD
Laboratory

Notes:

- 11/1/2022: HMPXV DNA removed.