Company ยท US
Abbott Point Of Care Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2026. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (2 in 12 months)
77recalls (3 in 12 months)
69recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 35 |
| CGA | Glucose Oxidase, Glucose | 12 |
| JGS | Electrode, Ion Specific, Sodium | 11 |
| JPI | Device, Hematocrit Measuring | 9 |
| MMI | Immunoassay Method, Troponin Subunit | 6 |
| GJS | Test, Time, Prothrombin | 5 |
| JBP | Activated Whole Blood Clotting Time | 5 |
| CGL | Electrode, Ion Based, Enzymatic, Creatinine | 2 |
| JFP | Electrode, Ion Specific, Calcium | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 2 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 |
| JFL | Ph Rate Measurement, Carbon-Dioxide | 1 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 |
| KHP | Acid, Lactic, Enzymatic Method | 1 |
| MYT | Biosensor, Immunoassay, Cpk Or Isoenzymes | 1 |
| NBC | Test, Natriuretic Peptide | 1 |
| QAT | Brain Trauma Assessment Test | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 26, 2026 | K261039 | i-STAT Crea cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | CGL |
| Jun 11, 2026 | K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity System Abbott Point of Care, Inc. | MMI |
| May 2, 2025 | K244014 | i-STAT CG4+ cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | CHL |
| Jan 3, 2025 | K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | MMI |
| Mar 27, 2024 | K234143 | i-STAT TBI Cartridge with the i-STAT Alinity System Abbott Point of Care | QAT |
| Oct 27, 2023 | K230300 | i-STAT CG8+ cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | JFP |
| Oct 27, 2023 | K230285 | i-STAT CG8+ cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | CHL |
| Oct 27, 2023 | K230275 | i-STAT CG8+ cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | JGS |
| Sep 15, 2023 | K223857 | i-STAT G3+ cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | CHL |
| Sep 11, 2023 | K223755 | i-STAT G cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | CGA |
| Jul 28, 2023 | K223710 | i-STAT CG8+ cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | CGA |
| Aug 13, 2021 | K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | CGA |
| Apr 9, 2020 | K200492 | i-STAT CG4+ Cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | CHL |
| Feb 28, 2020 | K183680 | i-STAT CHEM8+ cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | JPI |
| Feb 14, 2020 | K191360 | i-STAT CHEM8+ cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | JFP |
| Feb 7, 2020 | K191298 | i-STAT CHEM8+ cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | JFL |
| Feb 7, 2020 | K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | JGS |
| Feb 7, 2020 | K183678 | i-STAT CHEM8+ cartridge with the i-STAT 1 System Abbott Point of Care, Inc. | CGA |
| Apr 10, 2017 | K163271 | i-Stat Alinity System with i-Stat Glucose test Abbott Point of Care, Inc. | CGA |
| Jul 8, 2016 | K153357 | i-STAT Alinity System with i-STAT Sodium test Abbott Point of Care, Inc. | JGS |
| Apr 16, 2015 | K133002 | i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials Abbott Point of Care, Inc. | DHA |
| Feb 8, 2011 | K103195 | I-STAT 1 WIRELESS ANALYZER Abbott Point of Care, Inc. | CGA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2026 | Abbott Point Of Care Inc. i-STAT G3+ cartridge;
List Number: 03P78-26; Open, Classified |
CHL | K223857 |
| Apr 29, 2026 | Abbott Point Of Care Inc. i-STAT EG6+ cartridge;
List Number: 03P77-25; Open, Classified |
CHL | K940918 |
| Apr 29, 2026 | Abbott Point Of Care Inc. i-STAT EG7+ cartridge;
List Number: 03P76-25; Open, Classified |
CHL | K940918 |
| Sep 17, 2025 | Abbott Point Of Care Inc. i-STAT EG6+ cartridge. List Number: 03P77-25. Open, Classified |
CHL | None listed |
| Sep 17, 2025 | Abbott Point Of Care Inc. i-STAT EG7+ cartridge. List Number: 03P76-25. Open, Classified |
CHL | None listed |
| Sep 17, 2025 | Abbott Point Of Care Inc. i-STAT CG8+ cartridge. List Number: 03P88-25.
510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300 Open, Classified |
CHL | None listed |
| Sep 17, 2025 | Abbott Point Of Care Inc. i-STAT CG4+ cartridge (white). List Number: 03P85-25. Open, Classified |
CHL | K244014 K940918 +1 |
| Dec 22, 2020 | Abbott Point Of Care Inc. Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood.
List Numb Terminated |
CHL | K940918 |
| Dec 22, 2020 | Abbott Point Of Care Inc. Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood
Lis Terminated |
CHL | K940918 |
| Feb 18, 2020 | Abbott Point Of Care Inc. i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quantitative measurement of pH, pCO2, and pO2 in venous, arterial Terminated |
CHL | None listed |
| Feb 18, 2020 | Abbott Point Of Care Inc. i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT CG4+ cartridge is intended for the quantitative measurement of lactate, pH, pCO2, and pO2 in venous Terminated |
KHP | None listed |
| Feb 18, 2020 | Abbott Point Of Care Inc. i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge may be used for the quantitative measurement of sodium, potassium, chloride, bl Terminated |
JGS | None listed |
| Oct 16, 2019 | Abbott Point Of Care Inc. i-STAT cTnI cartridge Terminated |
MMI | K031739 K051433 |
| Sep 13, 2018 | Abbott Point Of Care Inc. Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood.
List Number/UDI# : 03P88-25 ,(01)10054749000163(17)181028(10) Terminated |
CHL | K940918 |
| Sep 12, 2017 | Abbott Point Of Care Inc. i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255) Terminated |
JQP | None listed |
| Aug 10, 2015 | Abbott Point Of Care Inc. i-Stat PT/INR Cartridges
List number 03P89-24
The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box.
a prothrombin time test useful in monitoring pati Terminated |
GJS | K020355 |
| Mar 27, 2014 | Abbott Point Of Care Inc. i-STAT G3+ Cartridge
pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances. Terminated |
CHL | K940918 |
| Dec 4, 2013 | Abbott Point Of Care Inc. Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540
The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as C Terminated |
GJS | K020355 |
| Nov 2, 2012 | Abbott Point Of Care Inc. Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039)
Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number Terminated |
JJT | K030768 |
| Aug 22, 2012 | Abbott Point Of Care Inc. i-STAT cTnI cartridges
Product Usage:
The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac Terminated |
MMI | K031739 |
| Aug 9, 2012 | Abbott Point Of Care Inc. i-Stat CK-MP cartridges
Abbott Point of Care Inc.
The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. C Terminated |
MYT | K051433 |
| Aug 9, 2012 | Abbott Point Of Care Inc. i-Stat BNP cartridges
Abbott Point of Care Inc.
The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma sampl Terminated |
NBC | K053597 |
| Aug 9, 2012 | Abbott Point Of Care Inc. i-Stat cTnl cartridges
Abbott Point of Care Inc.
The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma sampl Terminated |
MMI | K031739 |
| Aug 8, 2012 | Abbott Point Of Care Inc. I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA
This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin. Terminated |
GJS | K020355 |
| Aug 2, 2012 | Abbott Point Of Care Inc. I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ.
The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, parti Terminated |
CHL | K940918 |
| Jul 9, 2012 | Abbott Point Of Care Inc. Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 2 Terminated |
CHL | K001387 |
| Jul 9, 2012 | Abbott Point Of Care Inc. i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as por Terminated |
CHL | K001387 |
| Jul 9, 2012 | Abbott Point Of Care Inc. i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Terminated |
CHL | K001387 |
| Jul 9, 2012 | Abbott Point Of Care Inc. Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of Terminated |
CHL | K001387 |
| Jul 9, 2012 | Abbott Point Of Care Inc. i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analy Terminated |
CHL | K001387 |
| Jul 9, 2012 | Abbott Point Of Care Inc. iStat1 Analyzer
Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the Terminated |
CHL | K001387 |
| Nov 10, 2011 | Abbott Point Of Care Inc. i-Stat cTnI cartridges
Is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Terminated |
MMI | K031739 |
| Apr 18, 2011 | Abbott Point Of Care Inc. i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110
Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyt Terminated |
JGS | K053110 |
| Apr 1, 2011 | Abbott Point Of Care Inc. Cardiac Marker Control Calibration Verification Set, List number 136604/06F15-02.
Used to verify the accuracy of results over the measurement range of the i-STAT cTnI test. Terminated |
JJX | K031873 |
| Apr 1, 2011 | Abbott Point Of Care Inc. Cardiac Marker Control Level 1, List Number 136601-06F12-02; Cardiac Marker Control Level 2, List number 136602/06F13-02; and Cardiac Marker Control Level 3, List number 136603/06F14-02.
Used to ver Terminated |
JJX | K031873 |
| Mar 10, 2011 | Abbott Point Of Care Inc. i-STAT G3+ Cartridge: PCO2
Abbott Point of Care,
Princeton, NJ 08540
The test for PCO2, as part of the i-STAT System, is intended for use in the in vitro quantification of carbon dioxide partial pres Terminated |
CHL | K940918 |
| Feb 16, 2011 | Abbott Point Of Care Inc. Celite ACT Cartridge
Cartridge is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients und Terminated |
JBP | K992571 |
| Feb 2, 2011 | Abbott Point of Care Inc. i-STAT Level 2 Control Value Assignment Sheets
Human Consumption Terminated |
JJY | None listed |
| Jan 20, 2011 | Abbott Point of Care Inc. i-STAT G3+ Cartridge;
pH, pCO2, PO2; IVD
Abbott Point of Care
The test for PCO2, as part of the i-STAT System, is intended for use in the vitro quantification of carbon dioxide partial pressure in ar Terminated |
CHL | K940918 |
| Jan 20, 2011 | Abbott Point of Care Inc. i-STAT CG8+ Cartridge;
pH, pCO2, PO2, NA, K, iCa, Glu, Hct; IVD
Abbott Point of Care
The test for PCO2, as part of the i-STAT System, is intended for use in the vitro quantification of carbon dioxide Terminated |
CHL | K940918 |
| Dec 10, 2010 | Abbott Point Of Care Inc. Military Kit Portable Clinical Analyzer;
Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the Terminated |
CGA | K001387 |
| Dec 10, 2010 | Abbott Point Of Care Inc. i-STAT Portable Clinical Analyzer;
Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat Terminated |
CGA | K001387 |
| Dec 10, 2010 | Abbott Point Of Care Inc. Military Kit i-STAT1;
Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable ana Terminated |
CHL | K940918 |
| Dec 10, 2010 | Abbott Point Of Care Inc. i-STAT1 Abaxis Analyzer;
Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable Terminated |
CHL | K940918 |
| Dec 10, 2010 | Abbott Point Of Care Inc. FUSO Analyzer 300F
Abbott Point of Care, Princeton, NJ 08540
Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analy Terminated |
CHL | K940918 |
| Dec 10, 2010 | Abbott Point Of Care Inc. i-STAT Analyzer;
Abbott Point of Care, Princeton, NJ 08540
Model 200. the 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer Terminated |
CHL | K940918 |
| Nov 24, 2010 | Abbott Point of Care Inc. i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ. Terminated |
CGL | K973292 |
| Nov 17, 2010 | Abbott Point Of Care Inc. i-STAT ACT Kaolin Cartridges
in vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery. Terminated |
JBP | K023582 |
| Nov 17, 2010 | Abbott Point Of Care Inc. i-STAT ACT Celite Cartridges
in vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples. Terminated |
JBP | K992571 |
| Nov 3, 2010 | Abbott Point Of Care Inc. i-STAT BNP cartridge
Abbott Point of Care,
Princeton, NJ 08540 Terminated |
CHL | K053597 |
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