FDA.reportPublic FDA data

i-STAT

Primary DI
10054749005519
Brand
i-STAT
Company
ABBOTT POINT OF CARE INC.
Model
09P31-26
Catalog number
09P31-26
Device description
Cartridge, Chem8+
Published
2020-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CDSELECTRODE, ION SPECIFIC, UREA NITROGEN
CEMELECTRODE, ION SPECIFIC, POTASSIUM
CGAGLUCOSE OXIDASE, GLUCOSE
CGLELECTRODE, ION BASED, ENZYMATIC, CREATININE
CGZELECTRODE, ION-SPECIFIC, CHLORIDE
JFLpH rate measurement, carbon-dioxide
JFPElectrode, ion specific, calcium
JGSELECTRODE, ION SPECIFIC, SODIUM
JPIDEVICE, HEMATOCRIT MEASURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDSElectrode, Ion Specific, Urea NitrogenClinical Chemistry2
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CGAGlucose Oxidase, GlucoseClinical Chemistry2
CGLElectrode, Ion Based, Enzymatic, CreatinineClinical Chemistry2
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2
JFLPh Rate Measurement, Carbon-DioxideClinical Chemistry2
JFPElectrode, Ion Specific, CalciumClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
JPIDevice, Hematocrit MeasuringHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183678000
K183680000
K183688000
K191298000
K191360000
K210958000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183678000i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2020-02-07CGA
K183680000i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2020-02-28JPI
K183688000i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2020-02-07JGS
K191298000i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2020-02-07JFL
K191360000i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2020-02-14JFP
K210958000i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2021-08-13CGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00054749005512PackageGS125In Commercial Distribution
10054749005519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00054749005512000547490055120547490055120054749005512
1005474900551910054749005519

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius0
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)366-8020techsvc@apoc.abbott.com

Regulatory Flags#

DUNS number
079226216
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10054749000163i-STAT03P88-2503P88-252016-09-09
10054749000132i-STAT03P85-2503P85-252016-09-09
00054749004027i-STAT06F24-2006F24-202023-09-22
00054749001385i-STAT06F24-1606F24-162023-06-23
00054749004911i-STAT hs-TnI Calibration Verification, Levels 1-306P17-2006P17-202025-05-02
00054749004928i-STAT hs-TnI Control Level 106P17-2106P17-212025-05-02
00054749004935i-STAT hs-TnI Control Level 206P17-2206P17-222025-05-02
00054749004942i-STAT hs-TnI Control Level 306P17-2306P17-232025-05-02
10054749003058i-STAT hs-TnI cartridge09P81-2509P81-252025-04-29
00054749003051i-STAT hs-TnI cartridge09P81-2509P81-252025-04-29
10054749005779i-STAT TBI cartridge03S09-2503S09-252024-07-08
00054749005772i-STAT TBI cartridge03S09-2503S09-252024-07-08
00054749000661i-STAT06F14-0106F14-012023-06-23
10054749000071i-STAT03P79-2503P79-252016-09-09
10054749000149i-STAT03P86-2503P86-252016-09-09
10054749000170i-STAT03P89-2403P89-242016-09-09
10054749000187i-STAT03P90-2503P90-252016-09-09
10054749000200i-STAT03P92-2503P92-252016-09-09
10054749000217i-STAT03P93-2503P93-252016-09-09
10054749000118i-STAT03P83-2503P83-252016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00054749005710i-STAT G CartridgeABBOTT POINT OF CARE INC.CGA2024-04-30
10758750031658VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CGZ2023-04-28
10385480631645Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631652Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631669Nova Primary NOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480632307Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-22
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSCGA2022-08-09
10888277409187MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-11
10888277409170MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-10
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdCGA2020-09-11
08809301160862Pip Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2020-09-11
00024291121831On Call Express Blood Glucose Monitoring SystemNAVAJO MANUFACTURING COMPANYCGA2020-03-30
00024291121848On Call Express Blood Glucose Test StripsNAVAJO MANUFACTURING COMPANYCGA2020-03-30
00015482502300Assure® PlatinumARKRAY USA, INC.CGA2019-11-25
30804084000144IDEAL LIFE Blood Glucose Test Strips 1 vial of 25 Test StripsIdeal Life IncCGA2019-08-02
00015482512057GLUCOCARD® W Blood Glucose Test StripsARKRAY USA, INC.CGA2019-04-01
08809301160411Gmate Smart Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-09-17
08809301168011GlucoTrack Blood Glucose Test StripsPHILOSYS Co., LtdCGA2018-08-16
08809301168042GlucoTrack Blood Glucose Test StripsPHILOSYS Co., LtdCGA2018-08-16
08809301168080GlucoTrack Voice Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
08809301168097GlucoTrack VOICE Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
08809301168103GlucoTrack VOICE Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
08809301168110GlucoTrack SMART Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
08809301168127GlucoTrack SMART Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
08809301168134GlucoTrack SMART Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
08426950807575GEM Premier 5000 PAK BG/ISE/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807575GEM Premier 5000 PAK BG/ISE/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYJGS2018-01-24
08426950807575GEM Premier 5000 PAK BG/ISE/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYCEM2018-01-24
08426950807575GEM Premier 5000 PAK BG/ISE/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807582GEM Premier 5000 PAK BG/ISE/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24