# Biosite Incorporated

- Location (FDA's records): San Diego, CA
- FDA decisions: 46 (1990–2010): 45 510(k) clearances and 1 De Novo grant
- Product codes: NBC (9), DKZ (7), JJY (6), DIF (4), GGN (2), DAP (2), JJX (2), DJR (2), LDJ (1), LDP (1), MCB (1), JHX (1)
- Predicates its devices cite: 42 (25 its own); citations of its devices by later devices: 53 (25 its own)
- Recalls linked to its devices: 35 (11 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bio-Rad: 7 (https://510kreport.com/company/bio-rad)
- Syva Co.: 2 (https://510kreport.com/company/syva)
- Dade Behring, Inc.: 1 (https://510kreport.com/company/dade-behring)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)
- Prognostix, Inc.: 1 (https://510kreport.com/company/prognostix)
- American Bioproducts Co.: 1 (https://510kreport.com/company/american-bioproducts)
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)
- Microgenics Corp.: 1 (https://510kreport.com/company/microgenics)

## Firms that cite its devices most
- Bg Medicine, Inc.: 9 (https://510kreport.com/company/bg-medicine)
- Response Biomedical Corp.: 3 (https://510kreport.com/company/response-biomedical)
- Techlab, Inc.: 2 (https://510kreport.com/company/techlab)
- Quidel Cardiovascular, Inc.: 2 (https://510kreport.com/company/quidel-cardiovascular)
- American Bio Medica Corp.: 2 (https://510kreport.com/company/american-bio-medica)
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)
- Shenzhen Superbio Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-superbio-technology)

## Its most-cited devices
- K021317: Triage B-Type Natriuretic Peptide (BNP) Test (2002), cited by 6
- K973126: Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage Myoglobin, Triage Troponin-I and CK-MB, Triage Troponin-I (1997), cited by 5
- K973547: Triage Statmeter (1998), cited by 4
- K043242: Triage Tox Drug Screen (2005), cited by 3
- K051787: Triage BNP Test, Model 98000XR (2005), cited by 3
- K040437: Triage Profiler S.O.B. Panel (2004), cited by 2

## Recent decisions
- K092987: Inratio/INRATIO2 Test Strips (Jun 11, 2010)
- K092048: One Step Eddp (Methadone Metabolite) Test Strip (Apr 19, 2010)
- K093032: Triage Total 3 Controls and Calibration Verification Set (Nov 13, 2009)
- K080269: Triage Cardioprofiler and Profiler S.O.B. Panels (Jun 6, 2008)
- K072892: Triage Total Controls 5, Triage Total Calibration Verification 5 (Dec 7, 2007)
- K062840: Triage Protein C Controls and Calibration Verification Controls (Mar 1, 2007)
- K062530: Triage Protein C Test (Jan 29, 2007)
- K060788: Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414 (Jul 10, 2006)

Source page: https://510kreport.com/company/biosite