# K032993: Vitros Immunodiagnostic Products Anti-HBC Igm Controls

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Oct 31, 2003 after 36 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974613 (1998). 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)
- K974613: Virotrol Iii, Blackhawk Biosystems, Inc. (1998) Summary page 1.

## Recalls of this device
- Oct 15, 2021 · Class III · Z-0247-2022: Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. Whil

## Indications for use
The Vitros Immunodiagnostic Products Anti-HBc IgM Controls are intended for use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of IgM antibody to Hepatitis B core antigen (anti-HBc IgM) in human serum and plasma (heparin, EDTA or citrate). For in vitro diagnostic use.

Source page: https://510kreport.com/device/K032993
Methodology: https://510kreport.com/methodology