Trinity Biotech USA
Jamestown, NY, US
Trinity Biotech USA appears in FDA device records in Jamestown, NY. FDA records list 25 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Trinity Biotech USA 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.
- Clark Laboratories, Inc.510(k), enforcement report, recall
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)enforcement report, recall
510(k) clearance history
FDA records hold 25 510(k) clearances for Trinity Biotech USA between 1992 and 2014. The busiest year on record is 1992, with 8. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 8 |
| 1993 | 2 |
| 1998 | 4 |
| 1999 | 1 |
| 2000 | 1 |
| 2003 | 6 |
| 2004 | 2 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K140455 | CAPTIA MEASLES IGM | PCL | Substantially Equivalent | |
| K033106 | CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT | MYF | Substantially Equivalent | |
| K033105 | CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT | MXJ | Substantially Equivalent | |
| K033083 | BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM | LSR | Substantially Equivalent | |
| K033079 | CHLAMYDIA IGG ELISA TEST SYSTEM | LJC | Substantially Equivalent | |
| K033070 | BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM | LSR | Substantially Equivalent | |
| K033067 | PYLORI IGG | LYR | Substantially Equivalent | |
| K033064 | MYCOPLASMA IGG | LON | Substantially Equivalent | |
| K033051 | LEGIONELLA PNEUMOPHILA IGG/IGM | MJH | Substantially Equivalent | |
| K993839 | ENA PROFILE ELISA TEST SYSTEM | LLL | Substantially Equivalent | |
| K992665 | MACRA LP(A) ENZYME IMMUNOASSAY KIT | DFC | Substantially Equivalent | |
| K980912 | VCA IGG ELISA TEST SYSTEM | LSE | Substantially Equivalent | |
| K980596 | VCA IGM ELISA TEST SYSTEM | LSE | Substantially Equivalent | |
| K980598 | EBNA-1 IGM ELISA TEST SYSTEM | LLM | Substantially Equivalent | |
| K973123 | EA-D IGG ELISA TEST SYSTEM | LSE | Substantially Equivalent | |
| K931543 | ENCORE ENA COMBINED EIA | LLL | Substantially Equivalent | |
| K925826 | ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA | JZO | Substantially Equivalent | |
| K923537 | ENCORE DS-DNA | LRM | Substantially Equivalent | |
| K921870 | ENCORE SM/RNP | LLL | Substantially Equivalent | |
| K921572 | ENCORE SM | LLL | Substantially Equivalent | |
| K922340 | ENCORE SS-B | LLL | Substantially Equivalent | |
| K922157 | ENCORE SS-A | LLL | Substantially Equivalent | |
| K924056 | ENCORE RHEUMATOID FACTOR EIA | DHR | Substantially Equivalent | |
| K921573 | RUBELLA IGM | LFX | Substantially Equivalent | |
| K920150 | ENCORE SCL-70 | LKJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1318354 | 1318354 | Trinity Biotech USA | 2823 Girts Rd, Jamestown, NY 14701 US | 2026 | and 31 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- LKJAntinuclear Antibody, Antigen, Control
- GQOAntisera, Cf, Herpesvirus Hominis 1,2
- GQIAntiserum, Cf, Cytomegalovirus
- GNPAntiserum, Cf, Epstein-Barr Virus
- GQXAntiserum, Cf, Varicella-Zoster
- JISCalibrator, Primary
- JSMCulture Media, Non-Propagating Transport
- JHOElectrophoretic Separation, Lipoproteins
- LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- LJYEnzyme Linked Immunoabsorbent Assay, Mumps Virus
- LJZEnzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- LJBEnzyme Linked Immunoabsorbent Assay, Rubeola Igg
- PCLEnzyme Linked Immunoabsorbent Assay, Rubeola Igm
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- LFYEnzyme Linked Immunoabsorbent Assay, Varicella-Zoster
- LIPEnzyme Linked Immunoabsorption Assay, Treponema Pallidum
- MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
- MYFEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
- LSEEpstein-Barr Virus, Other
- LLLExtractable Antinuclear Antibody, Antigen And Control
- LYRHelicobacter Pylori
- JNLImmunochemical, Thyroglobulin Autoantibody
- MJHLegionella, Spp., Elisa
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
- KITMedia And Components, Synthetic Cell And Tissue Culture
- OAXPlasmodium Spp. Detection Reagents
- LSRReagent, Borrelia Serological Reagent
- QKOReagent, Coronavirus Serological
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- JSKSupplement, Culture Media
- LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- DHRSystem, Test, Rheumatoid Factor
- JZOSystem, Test, Thyroid Autoantibody
- MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)
- LLMTest, Antigen, Nuclear, Epstein-Barr Virus
- KHGWhole Blood Hemoglobin Determination
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2292-2025 | Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease. | Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter. | Class II | Open, Classified | |
| Z-0382-2022 | Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440 | Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay | Class II | Terminated | |
| Z-1503-2021 | Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection. | Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting | Class II | Terminated | |
| Z-0624-2019 | Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only. | lack of 510K | Class II | Terminated | |
| Z-0623-2019 | Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only. | lack of 510K | Class II | Terminated | |
| Z-0622-2019 | Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only. | lack of 510K | Class II | Terminated | |
| Z-0621-2019 | Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only. | lack of 510K | Class II | Terminated | |
| Z-0620-2019 | ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only. | lack of 510K | Class II | Terminated | |
| Z-2782-2016 | Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD | The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range). | Class III | Terminated | |
| Z-0819-2015 | Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum. | Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months. | Class III | Terminated | |
| Z-0572-2014 | Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis). It is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis. | Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results. | Class II | Terminated | |
| Z-2445-2012 | Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera. | The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range. | Class III | Terminated | |
| Z-0261-05 | AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract of rabbit brain with buffer, stabilizers and calcium chloride. Responsible firm on the label: Trinity Biotech PLC, IDA Business Park, Bray, County Wicklow, Ireland. USA Enquiries - Trinity Biotech USA, 1930 Innerbelt Business Center Drive, St. Louis, MO 63114, USA. | Prolongation of Prothrombin times in patient samples, resulting in a falsely elevated INR value. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain