# Roche Diagnostics Operations

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 9 (2012–2025): 7 510(k) clearances and 2 original PMA approvals
- Names in FDA's records: Roche Diagnostics Operations (5); Roche Diagnostics Operations, Inc. (4)
- Product codes: MZO (1), LCP (1), LAO (1), PDJ (1), DFC (1), NBW (1), LFR (1), DCF (1), LOM (1)
- Predicates its devices cite: 8 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostics Corp.: 6 (https://510kreport.com/company/roche-diagnostics)
- Siemens Medical Solutions Diagnostics: 1 (https://510kreport.com/company/siemens-medical-solutions-diagnostics)
- Ark Diagnostics, Inc.: 1 (https://510kreport.com/company/ark-diagnostics)

## Firms that cite its devices most
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)
- Alere Technologies AS: 1 (https://510kreport.com/company/alere-technologies)

## Its most-cited devices
- P140021: Elecsys Anti-HCV II Immunoassay, Elecsys Precicontrol Anti-HCV (2015), cited by 1
- K121610: Cobas C 501 Tina-Quant HBA1CDX Gen.3 Assay (2013), cited by 1
- K131366: Accu-Chek Aviva Expert Blood Glucose Monitoring System (2013), cited by 1

## Recent decisions
- K241220: Tina-quant Lipoprotein (a) Gen.2 Molarity (Jan 24, 2025)
- K233454: ONLINE TDM Methotrexate (Feb 20, 2024)
- K163633: cobas HbA1c Test, cobas b 101 system (Jul 28, 2017)
- P140021: Elecsys Anti-HCV II Immunoassay, Elecsys Precicontrol Anti-HCV (Jun 11, 2015)
- P130015: Elecsys® Hbeag Immunoassay and Elecsys® Precicontrol Hbeag (Mar 14, 2014)
- K131366: Accu-Chek Aviva Expert Blood Glucose Monitoring System (Oct 11, 2013)
- K131029: Accu-Chek Aviva Plus Test Strip (Aug 9, 2013)
- K121610: Cobas C 501 Tina-Quant HBA1CDX Gen.3 Assay (Aug 8, 2013)

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