Data / Medical devices / United States / Trinity Biotech (Primus Corporation dba Trinity Biotech)
Trinity Biotech (Primus Corporation dba Trinity Biotech): FDA-registered device maker in Kansas City, MO, United States, 2 510(k) clearances
Trinity Biotech (Primus Corporation dba Trinity Biotech) is registered with the FDA (registration 1931251) in Kansas City, MO, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 4, 2023. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1931251
- Address
- 4231 E 75th Ter, Kansas City, MO, United States, 64132
- Owner or operator
- TRINITY BIOTECH, PLC (9025161)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- February 9, 2012
- Registered through
- 2026
- Brand names listed
- A. Menarini Premier Hb9210 Assay Components, Premier Hb9210 HbA1c Assay Components, Premier Resolution Analyzer, Premier Resolution Assay Components, TRI-stat 2 Analyzer, TRI-stat Assay Components, ultra2 Genesys Variants Analyzer, ultra2 Genesys Variants Assay Components and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abnormal Hemoglobin Quantitation | GKA | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Manufacturer for export | accessdata.fda.gov |
| Assay, Glycosylated Hemoglobin | LCP | 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 |
|---|---|---|---|---|---|---|
| August 4, 2023 | K222635 | Premier Resolution System | GKA | Substantially Equivalent | Trinity Biotech (Primus Corporation, Dba Trinity Biotech) | accessdata.fda.gov |
| November 22, 2011 | K112015 | PREMIER HB9210 HBA1C ANALYZER | LCP | Substantially Equivalent | Primus Corporation Dba Trinity Biotech | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 5, 2021 | 91054 | Class III | Terminated | 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 | accessdata.fda.gov |
| October 9, 2020 | 86598 | Class II | Terminated | Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation | The product did not receive pre-market approval or clearance. | accessdata.fda.gov |
Compare with other makers
- All makers of Abnormal Hemoglobin Quantitation
- All makers of Assay, Glycosylated Hemoglobin
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Updated August 4, 2023. 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.