# K033127: Vitros Immunodiagnostic Products Anti-HBC Controls

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics
- Decided: Oct 31, 2003 after 31 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
- K930016: Blackhawk BioSystems, Inc. VIROTROL 1 (Multi-Marker Positive Control). The summary prints BK930016, a CBER number, which our reading took as K930016, 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 total antibody (IgG and IgM) to hepatitis B core antigen (total anti-HBc) in human serum and plasma (EDTA and citrate). The performance of the Vitros Immunodiagnostic Products Anti-HBc Controls has not been established with any other anti-HBc assays.

Source page: https://510kreport.com/device/K033127
Methodology: https://510kreport.com/methodology