# K012561: Vitros Immunodiagnostic Products Anti-HCV Controls

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics
- Decided: Aug 29, 2001 after 21 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K930027: Boston Biomedica, Inc. ACCURUN 1® Multi-Marker Positive Control. The summary prints BK930027, a CBER number, which our reading took as K930027, which is not in FDA’s 510(k) list. Kept off the family tree. Summary page 1.

## Indications for use
For use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma (heparin, EDTA or citrate). The performance of the Vitros Immunodiagnostic Products Anti-HCV Controls has not been established with any other anti-HCV assays.

Source page: https://510kreport.com/device/K012561
Methodology: https://510kreport.com/methodology