# K221693: Elecsys Anti-HCV II (08837031190)

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jan 4, 2023 after 208 days
- Product code: MZO (Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus)
- Device class: 2
- Regulation: 21 CFR 866.3169
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P140021 (2015). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P140021: Elecsys Anti-HCV II Immunoassay, Elecsys Precicontrol Anti-HCV, Roche Diagnostics Operations, Inc. (2015) Summary page 5.

## Indications for use
Immunoassay for the in vitro qualitative detection of antibodies to hepatitis C virus (HCV) in human adult and pediatric (ages 18 months through 21 years) serum and plasma (potassium EDTA, lithium heparin, sodium heparin, and sodium citrate). Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection. The test does not determine the state of infection or associated disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K221693
Methodology: https://510kreport.com/methodology