# K181092: CHROMID CARBA agar (CARB)

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux S.A.
- Decided: Jul 6, 2018 after 72 days
- Product code: JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar)
- Device class: 2
- Regulation: 21 CFR 866.1700
- 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: 2 generations back to K972359 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091025: Chromid Vre Agar, Model: Ref 43 851, bioMerieux, Inc. (2010) Summary page 4.

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0839-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed

## Indications for use
CHROMID® CARBA agar is a selective and differential chromogenic medium that is intended for the qualitative detection and presumptive identification of carbapenemase-producing Escherichia coli and Klebsiella pneumoniae in rectal swab specimens from patients at risk of colonization. CHROMID® CARBA agar is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. Rectal swabs are inoculated directly onto CHROMID® CARBA agar without enrichment and results can be interpreted after incubation for 18-24 hours. Presumptive carbapenemase-producing colonies of E. coli appear pink to burgundy and those of K. pneumoniae appear blue-green or blue-grey. Other organisms besides carbapenemase-producing E. coli and K. pneumoniae can also grow on CHROMID® CARBA agar with colonies that appear pink to burgundy or blue-green to blue-grey. Sub-culture to non-selective medium is required to confirm organism identity, for antimicrobial susceptibility testing, confirmation of carbapenemase production and epidemiological typing. A lack of growth or the absence of pink to burgundy or blue-green to blue-grey colonies does not preclude the carriage of carbapenemase producing organisms.

Source page: https://510kreport.com/device/K181092
Methodology: https://510kreport.com/methodology