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Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA product code LTJ · Class 2 · Immunology
31
Registered devices
653
Adverse events
12
Recalls
34
510(k) clearances
Devices with this code
Total PSA Extra Sensitive AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.Total PSA Extra Sensitive AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.Free PSA AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.FastPack® Total PSA Kit (50) — QUALIGEN INC.ADVIA Centaur® PSA — Siemens Healthcare Diagnostics Inc.Total PSA AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.Atellica IM PSA — Siemens Healthcare Diagnostics Inc.Total PSA AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.Free fPSA AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.Total PSA AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.FastPack® IP Total PSA Kit (30) — QUALIGEN INC.Monobind AccuLite Free PSA CLIA Kit - 192 Wells — MONOBIND, INC.ARCHITECT — Abbott Ireland DiagnosticsTotal PSA Extra Sensitive AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.VITROS — ORTHO CLINICAL DIAGNOSTICSAtellica IM PSA — Siemens Healthcare Diagnostics Inc.Total PSA AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.Elecsys free PSA — Roche Diagnostics GmbHFree fPSA AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.ADVIA Centaur® PSA — Siemens Healthcare Diagnostics Inc.FREND PSA Plus — NanoEnTek, Inc.ST AIA-PACK PA — TOSOH CORPORATIONVITROS — ORTHO CLINICAL DIAGNOSTICSARCHITECT — Abbott Ireland Diagnostics
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, dependin |
| 2016-08-09 | Siemens Healthcare Diagnostics, Inc | Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence |
| 2013-11-08 | Qualigen Inc | Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
| 2008-09-29 | Qualigen Inc | The recall was initiated after the firm investigation of customer complaints of falsely elevated results determined the product was not meeting product performa |
| 2008-05-21 | Siemens Medical Solutions Diagnostics | The field action was initiated after the firm confirmed that the Coat-A-Count PSA IRMA kit (IKPS1, 2, 5, X) exhibits a low bias, which is evident when comparing |
| 2008-01-08 | Beckman Coulter Inc | Beckman Coulter incorrectly shipped Access Hybritech PSA calibrators containing dual calibration cards (Hybritech and WHO) to some Access Hybritech PSA Customer |
| 2005-12-07 | Roche Diagnostics Corp. | There is the possibility of high results with sera expected to have non-detectable levels of tPSA if these reagent lots are used in combination on the Modular A |
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