# Roche Diagnostics Corp.

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 480 (1985–2026): 459 510(k) clearances, 4 De Novo grants and 17 original PMA approvals
- Names in FDA's records: Roche Diagnostics Corp. (276); Roche Diagnostics (190); Roche Diagnostics GmbH (7); Roche Diagnostics Corporation (6); Roche Diagnostics, Inc. (1)
- Product codes: JJX (60), JJY (22), NBW (19), JIT (18), JIX (14), GJS (14), LFR (12), SEI (10), DKZ (10), CGN (7), JZO (7), NBC (7)
- 510(k) review time since 2016: median 119 days, against 145 for FDA's reviews in the same codes and years (5 of 10 faster)
- Predicates its devices cite: 474 (237 its own); citations of its devices by later devices: 516 (237 its own)
- Recalls linked to its devices: 170 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostic Systems, Inc.: 77 (https://510kreport.com/company/roche-diagnostic-systems)
- Boehringer Mannheim Corp.: 65 (https://510kreport.com/company/boehringer-mannheim)
- Fujirebio Diagnostics,Inc.: 7 (https://510kreport.com/company/fujirebio-diagnostics)
- Roche Molecular Systems, Inc.: 5 (https://510kreport.com/company/roche-molecular-systems)
- International Technidyne Corp.: 5 (https://510kreport.com/company/international-technidyne)
- Behring Diagnostics, Inc.: 4 (https://510kreport.com/company/behring-diagnostics)
- Diagnostic Products Corp.: 4 (https://510kreport.com/company/diagnostic-products)
- Beckman Coulter, Inc.: 4 (https://510kreport.com/company/beckman-coulter)

## Firms that cite its devices most
- Siemens Healthcare Diagnostics, Inc.: 37 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Elitechgroup: 21 (https://510kreport.com/company/elitechgroup)
- Hitachi Chemical Diagnostics, Inc.: 14 (https://510kreport.com/company/hitachi-chemical-diagnostics)
- Seppim S.A.S.: 11 (https://510kreport.com/company/seppim)
- Dade Behring, Inc.: 10 (https://510kreport.com/company/dade-behring)
- Roche Diagnostics Operations (Rdo): 8 (https://510kreport.com/company/roche-diagnostics-operations-rdo)
- Abbott Laboratories: 8 (https://510kreport.com/company/abbott-laboratories)
- Ortho-Clinical Diagnostics, Inc.: 8 (https://510kreport.com/company/ortho-clinical-diagnostics)

## Its most-cited devices
- K033501: Modification to Calibrator for Automatic Systems (Cfas) (2003), cited by 17
- K041227: Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera (2004), cited by 16
- K043474: Accu-Chek Aviva System (2005), cited by 10
- K100853: Cobas 8000 Modular Series Analyzer (2010), cited by 9
- K022516: Elecsys Probnp Immunoassay (2002), cited by 9
- K021513: Accu-Chek Advantage Module (2002), cited by 8

## Recent decisions
- DEN260027: Elecsys HBsAg II quant II RxDx (Oct 20, 2026)
- K260232: Elecsys EBV VCA IgG (Oct 2, 2026)
- K260233: Elecsys EBV IgM (Oct 2, 2026)
- K260221: Elecsys EBV EBNA IgG (Oct 2, 2026)
- K261686: Elecsys Phospho-Tau (217P) Plasma (Aug 19, 2026)
- K252323: cobas pulse blood glucose monitoring system (Jun 12, 2026)
- K252431: Elecsys Calcitonin (Apr 24, 2026)
- K252280: Elecsys Anti-SARS-CoV-2 S (Apr 13, 2026)

Source page: https://510kreport.com/company/roche-diagnostics