# K042303: Vitros Immunodiagnostic Products Anti-HBS Controls

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics
- Decided: Sep 27, 2004 after 33 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
Longest line of descent: 1 generation back to K003112 (2000). 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)
- K003112: Vitros Immunodiagnostic Products Anti-HBS Controls, Ortho-Clinical Diagnostics, Inc. (2000) Summary page 1.

## Indications for use
The VITROS Immunodiagnostic Products Anti-HBs Controls are intended for use in monitoring the performance of the VITROS Immunodiagnostic System when used for the quantitative in vitro determination of total antibody to Hepatitis B surface antigen (anti-HBs) in human serum when using the VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack on the VITROS Immunodiagnostic System. The performance of the VITROS Immunodiagnostic Products Anti-HBs Controls has not been established with any other anti-HBs assays. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K042303
Methodology: https://510kreport.com/methodology