# K162076: chromID MRSA

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Oct 25, 2016 after 90 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K092407 (2010). 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)
- K092407: Remel Spectra Mrsa, Remel, Inc. (2010) Summary page 4.

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0802-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- Nov 9, 2022 · Class II · Z-0842-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed

## Indications for use
chromID™ MRSA agar is a selective and differential chromogenic medium for : A. The qualitative detection of nasal colonization of methicillin-resistant Staphylococcus aureus (MRSA), to aid in the prevention and control of MRSA in healthcare settings. The test is performed on anterior nares swab specimens from patients and healthcare workers to screen for MRSA colonization. chromID™ MRSA when used to detect nasal colonization is not intended to diagnose, guide, or monitor therapy for MRSA infections, or provide results of susceptibility to methicillin. B. The qualitative detection of MRSA from skin and skin structure infections. chromID™ MRSA is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA infections. Concomitant cultures for skin and skin structure infections are necessary to recover organisms for further microbiological susceptibility testing or epidemiological typing. A negative result does not preclude MRSA infection. chromID™ MRSA is not intended to monitor treatment for MRSA infections, or provide results of susceptibility to methicillin. C. The qualitative detection of MRSA from positive blood cultures demonstrating Gram-positive cocci on Gram stain. chromID™ MRSA is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA infections. Sub-culturing for positive blood cultures are necessary to recover organisms for further microbiological susceptibility testing or epidemiological typing. A negative result does not prectude. MRSA infection. chromID™ MRSA is not intended to monitor treatment for MRSA infections, or provide results of susceptibility to methicillin.

Source page: https://510kreport.com/device/K162076
Methodology: https://510kreport.com/methodology