# K073027: Spectra Mrsa

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Feb 28, 2008 after 125 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Remel Spectra TM MRSA is a selective and differential chromogenic medium recommended for use in the qualitative detection of nasal colonization of methicillin-resistant Staphylococcocus aureus (MRSA) to aid in the prevention and control of MRSA in healthcare settings. The test is performed with anterior nares swab specimens from patients and healthcare workers to screen for MRSA colonization. Spectra TM MRSA is not intended to diagnose MRSA infection or to guide or monitor treatment for infections.

Source page: https://510kreport.com/device/K073027
Methodology: https://510kreport.com/methodology