Trinity Biotech (Primus Corporation dba Trinity Biotech)

Kansas City, MO, US

Trinity Biotech (Primus Corporation dba Trinity Biotech) appears in FDA device records in Kansas City, MO. FDA records list 16 510(k) clearances between 1989-06-16 and 2023-08-04, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 3 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 16
PMA records: 0
Recall records: 3
Registered establishments: 1

FDA records under these names

2 names

FDA records resolved to Trinity Biotech (Primus Corporation dba Trinity Biotech) carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Primus Corporation Dba Trinity Biotech510(k), enforcement report, recall
Primus, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 16 510(k) clearances for Trinity Biotech (Primus Corporation dba Trinity Biotech) between 1989 and 2023. The busiest year on record is 1994, with 5. The most recent is 2023, with 1.

Clearances by year, as a table

510(k) clearance decisions for Trinity Biotech (Primus Corporation dba Trinity Biotech), by decision year
Year	Clearances
1989	1
1990	1
1994	5
1996	1
1999	2
2000	1
2002	2
2007	1
2011	1
2023	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K222635	Premier Resolution System	GKA	Substantially Equivalent	2023-08-04
K112015	PREMIER HB9210 HBA1C ANALYZER	LCP	Substantially Equivalent	2011-11-22
K062658	PRIMUS A1CARE ASSAY	LCP	Substantially Equivalent	2007-11-26
K013787	NYCOCARD CRP	DCK	Substantially Equivalent	2002-05-14
K014084	NYCOCARD CRP CONTROL	DCK	Substantially Equivalent	2002-01-07
K993131	NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY	LCP	Substantially Equivalent	2000-05-22
K994045	PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2	LCP	Substantially Equivalent	1999-12-21
K992921	PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II	LCP	Substantially Equivalent	1999-11-12
K955283	PRIMUS VARIANT SYSTEM PVS99	GKA	Substantially Equivalent	1996-03-01
K942009	PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY	LCP	Substantially Equivalent	1994-09-14
K940008	GLYCATED PROTEIN CALIBRATORS	JIS	Substantially Equivalent	1994-05-09
K940142	GLYCATED PROTEIN CONTROLS	JJX	Substantially Equivalent	1994-04-26
K936204	GLYCATED HEMOGLOBIN CALIBRATORS	LCP	Substantially Equivalent	1994-03-22
K940143	GLYCATED HEMOGLOBIN CONTROLS	LCP	Substantially Equivalent	1994-03-15
K896582	DIABETES CARE(TM) TEST PACKAGE FOR THE CLC 330(TM)	LCP	Substantially Equivalent	1990-06-28
K891235	PRIMUS MODEL CLC 330	LCP	Substantially Equivalent	1989-06-16

Registered establishments

FDA registered establishments for Trinity Biotech (Primus Corporation dba Trinity Biotech), with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1931251	1931251	Trinity Biotech (Primus Corporation dba Trinity Biotech)	4231 E 75th Ter, KANSAS CITY, MO 64132 US	2026	GKA JJE LCP

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0350-2023	Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis	The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, the unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.	Class III	2021-10-05	Terminated
Z-0349-2023	A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis	The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. The unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.	Class III	2021-10-05	Terminated
Z-0321-2021	Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation	The product did not receive pre-market approval or clearance.	Class II	2020-10-09	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain