# K163042: chromID Strepto B agar

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jan 27, 2017 after 88 days
- Product code: PQZ (Gbs Culture Media, Selective And Differential)
- Device class: 1
- Regulation: 21 CFR 866.2360
- 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 K881577 (1988). 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)
- K881577: Modified Selective Streptococcus Agar, Acumedia Manufacturers, Inc. (1988) Summary page 4.

## Most influential descendants
- K173903: Granada Medium (2018), 0 descendants of its own

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0847-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed

## Indications for use
chromID® Strepto B agar is a selective chromogenic medium that is intended to aid in the qualitative determination of Group B Streptococcus (GBS) colonization in pregnant women. This medium supports the growth of, but does not differentiate between, hemolytic and non-hemolytic GBS strains. The test is performed on 18-24 hour LIM broth enrichments of vaginal/rectal swabs obtained from pregnant women. chromID® Strepto B agar results can be interpreted after 24 hours incubation with confirmation of characteristic GBS colonies from the media. chromID® Strepto B agar is not intended to diagnose infection nor to guide or monitor treatment for infections. chromID® Strepto B agar does not provide susceptibility results. Subculture to non-selective media should be performed as needed for susceptibility testing. chromID® Strepto B agar is intended for use by laboratory health practitioners in a clinical laboratory.

Source page: https://510kreport.com/device/K163042
Methodology: https://510kreport.com/methodology