Data / Medical devices / Canada / Abbott Point Of Care Canada Limited

Abbott Point Of Care Canada Limited: FDA-registered device maker in Ottawa Ontario, Canada, 38 510(k) clearances

Name: Abbott Point Of Care Canada Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Abbott Point Of Care Canada Limited is registered with the FDA (registration 3005643513) in Ottawa Ontario, Canada. It lists 24 device types. The FDA files 38 510(k) clearances under its listings, the newest dated May 2, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005643513
Address: 185 Corkstown Road, Ottawa Ontario, Canada, K2H 8V4
Owner or operator: ABBOTT LABORATORIES (1415939)
Roles: Manufacturer, Specification developer
First device listed: March 23, 2006
Registered through: 2026
Brand names listed: Alinity c CRP Vario HS Control Kit (LN 07P5612), Alinity c Proteins Control Kit (LN 08P6712), Alinity i Anti-CCP Controls (LN 09P2710), Alinity i STAT CK-MB Controls (LN 04V3810), Alinity i STAT Myoglobin Controls (LN 04V3710), I-STAT BNP TEST, I-STAT CK-MB TEST, I-STAT CREATININE TEST and more

Devices it lists

Device	Product code	Class	Role	Source
Acid, Lactic, Enzymatic Method	KHP	1	Manufacturer	accessdata.fda.gov
Activated Whole Blood Clotting Time	JBP	2	Manufacturer	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Manufacturer	accessdata.fda.gov
Biosensor, Immunoassay, Cpk Or Isoenzymes	MYT	2	Manufacturer	accessdata.fda.gov
Brain Trauma Assessment Test	QAT	2	Manufacturer	accessdata.fda.gov
Control, Hematocrit	GLK	2	Specification developer	accessdata.fda.gov
Device, Hematocrit Measuring	JPI	2	Manufacturer	accessdata.fda.gov
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	CHL	2	Manufacturer	accessdata.fda.gov
Electrode, Ion Based, Enzymatic, Creatinine	CGL	2	Manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Calcium	JFP	2	Manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Urea Nitrogen	CDS	2	Manufacturer	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Manufacturer	accessdata.fda.gov
Electrolyte Controls (Assayed And Unassayed)	JJR	1	Specification developer	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Manufacturer	accessdata.fda.gov
Immunoassay Method, Troponin Subunit	MMI	2	Manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Specification developer	accessdata.fda.gov
Ph Rate Measurement, Carbon-Dioxide	JFL	2	Manufacturer	accessdata.fda.gov
Plasma, Coagulation Control	GGN	2	Specification developer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer, Specification developer	accessdata.fda.gov
System, Test, Human Chorionic Gonadotropin	DHA	2	Manufacturer	accessdata.fda.gov
Test, Natriuretic Peptide	NBC	2	Manufacturer	accessdata.fda.gov
Test, Time, Prothrombin	GJS	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 2, 2025	K244014	i-STAT CG4+ cartridge with the i-STAT 1 System	CHL	Substantially Equivalent	Abbott Point of Care, Inc.	accessdata.fda.gov
January 3, 2025	K240984	i-STAT hs-TnI cartridge with the i-STAT 1 System	MMI	Substantially Equivalent	Abbott Point of Care, Inc.	accessdata.fda.gov
March 27, 2024	K234143	i-STAT TBI Cartridge with the i-STAT Alinity System	QAT	Substantially Equivalent	Abbott Point of Care	accessdata.fda.gov
October 27, 2023	K230300	i-STAT CG8+ cartridge with the i-STAT 1 System	JFP	Substantially Equivalent	Abbott Point of Care, Inc.	accessdata.fda.gov
October 27, 2023	K230285	i-STAT CG8+ cartridge with the i-STAT 1 System	CHL	Substantially Equivalent	Abbott Point of Care, Inc.	accessdata.fda.gov
October 27, 2023	K230275	i-STAT CG8+ cartridge with the i-STAT 1 System	JGS	Substantially Equivalent	Abbott Point of Care, Inc.	accessdata.fda.gov
September 15, 2023	K223857	i-STAT G3+ cartridge with the i-STAT 1 System	CHL	Substantially Equivalent	Abbott Point of Care, Inc.	accessdata.fda.gov
September 11, 2023	K223755	i-STAT G cartridge with the i-STAT 1 System	CGA	Substantially Equivalent	Abbott Point of Care, Inc.	accessdata.fda.gov
July 28, 2023	K223710	i-STAT CG8+ cartridge with the i-STAT 1 System	CGA	Substantially Equivalent	Abbott Point of Care, Inc.	accessdata.fda.gov
July 14, 2023	K220282	i-STAT PTplus Cartridge with the i-STAT 1 System	GJS	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
August 13, 2021	K210958	i-STAT CHEM8+ cartridge with the i-STAT 1 System	CGA	Substantially Equivalent	Abbott Point of Care, Inc.	accessdata.fda.gov
January 8, 2021	K201778	i-STAT TBI Plasma cartridge with the i-STAT Alinity System	QAT	Substantially Equivalent	Abbott Laboratories	accessdata.fda.gov
April 9, 2020	K200492	i-STAT CG4+ Cartridge with the i-STAT 1 System	CHL	Substantially Equivalent	Abbott Point of Care, Inc.	accessdata.fda.gov
February 28, 2020	K183680	i-STAT CHEM8+ cartridge with the i-STAT 1 System	JPI	Substantially Equivalent	Abbott Point of Care, Inc.	accessdata.fda.gov
February 14, 2020	K191360	i-STAT CHEM8+ cartridge with the i-STAT 1 System	JFP	Substantially Equivalent	Abbott Point of Care, Inc.	accessdata.fda.gov
February 7, 2020	K191298	i-STAT CHEM8+ cartridge with the i-STAT 1 System	JFL	Substantially Equivalent	Abbott Point of Care, Inc.	accessdata.fda.gov
February 7, 2020	K183688	i-STAT CHEM8+ cartridge with the i-STAT 1 System	JGS	Substantially Equivalent	Abbott Point of Care, Inc.	accessdata.fda.gov
February 7, 2020	K183678	i-STAT CHEM8+ cartridge with the i-STAT 1 System	CGA	Substantially Equivalent	Abbott Point of Care, Inc.	accessdata.fda.gov
July 8, 2016	K153357	i-STAT Alinity System with i-STAT Sodium test	JGS	Substantially Equivalent	Abbott Point of Care, Inc.	accessdata.fda.gov
April 16, 2015	K133002	i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials	DHA	Substantially Equivalent	Abbott Point of Care, Inc.	accessdata.fda.gov
May 31, 2013	K120900	I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2	GGN	Substantially Equivalent	Cliniqa Corporation	accessdata.fda.gov
May 18, 2012	K121237	BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE	JJX	Substantially Equivalent	Cliniqa Corporation	accessdata.fda.gov
February 8, 2011	K103195	I-STAT 1 WIRELESS ANALYZER	CGA	Substantially Equivalent	Abbott Point of Care, Inc.	accessdata.fda.gov
June 2, 2008	K080973	CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC	JJY	Substantially Equivalent	Cliniqa Corporation	accessdata.fda.gov
July 21, 2006	K053597	I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)	NBC	Substantially Equivalent	I-Stat Corporation	accessdata.fda.gov
January 13, 2006	K053110	Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge	JGS	Substantially Equivalent	I-Stat Corporation	accessdata.fda.gov
December 15, 2005	K051433	I-STAT CREATINE KINASE MB (CK-MB)	MYT	Substantially Equivalent	I-Stat Corporation	accessdata.fda.gov
September 8, 2003	K023582	I-STAT KAOLIN ACT TEST	JBP	Substantially Equivalent	I-Stat Corporation	accessdata.fda.gov
September 2, 2003	K031739	I-STAT CARDIAC TROPONIN (CTNI) TEST	MMI	Substantially Equivalent	I-Stat Corporation	accessdata.fda.gov
May 14, 2002	K020355	I-STAT PROTHROMBIN TIME TEST	GJS	Substantially Equivalent	I-Stat Corporation	accessdata.fda.gov
February 10, 2000	K992571	I-STAT SYSTEM	JBP	Substantially Equivalent	I-Stat Corp.	accessdata.fda.gov
June 29, 1998	K982071	I-STAT LACTATE TEST	KHP	Substantially Equivalent	I-Stat Corp.	accessdata.fda.gov
October 20, 1997	K973292	I-STAT SYSTEM	CGL	Substantially Equivalent	I-Stat Corp.	accessdata.fda.gov
August 28, 1997	K972868	TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL	JJY	Substantially Equivalent	Bionostics, Inc.	accessdata.fda.gov
March 1, 1996	K955630	RNA MEDICAL HEMAT CONTROL	JJR	Substantially Equivalent	Bionostics, Inc.	accessdata.fda.gov
May 10, 1994	K940918	I-STAT 200 PORTABLE CLINICAL ANALYZER	CHL	Substantially Equivalent	I-Stat Corp.	accessdata.fda.gov
July 1, 1991	K912387	I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK	JGS	Substantially Equivalent	I-Stat Corp.	accessdata.fda.gov
October 16, 1989	K894914	MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK	JGS	Substantially Equivalent	I-Stat Corp.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
November 1, 2012	64043	Class II	Terminated	Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of c	APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack.	accessdata.fda.gov

Compare with other makers

Updated May 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.