# K030067: Vitros Immunodiagnostic Products Hbsag Controls

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics
- Decided: Jan 17, 2003 after 10 days
- Product code: MJX (Kit, Serological, Positive Control)
- 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 K011250 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011250: Vitros Immunodiagnostic Products Hbsag Controls, Ortho-Clinical Diagnostics, Inc. (2001)

## Most influential descendants
- K150815: BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit (2015), 0 descendants of its own

## Recalls of this device
- Jun 22, 2016 · Class III · Z-0313-2017: The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Increased results may occur on both the negative and positive Controls. The positive Con

## Indications for use
For use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (EDTA, citrate and heparin). The performance of the Vitros Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assays. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K030067
Methodology: https://510kreport.com/methodology