# K162620: Remel Spectra ESBL

- Pathway: 510(k) (Traditional)
- Applicant: Remel, Inc.
- Decided: May 1, 2017 after 223 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
Longest line of descent: 3 generations back to K972359 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160512: HardyCHROM ESBL, Hardy Diagnostics (2016). Cleared while this submission was under review Summary page 5.

## Indications for use
Remel Spectra ESBL is a selective and differential growth medium for use in primary isolation and presumptive identification of Extended Spectrum β Lactamase (ESBL)-producing Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca and Proteus mirabilis to aid in prevention and control of these bacteria in a healthcare setting. Testing may be performed from either perirectal swabs or fresh stool specimens. Remel Spectra ESBL is not intended to diagnose ESBL infection, or to guide or monitor treatment. Do not report Spectra ESBL positive screening results. Subculture of presumptively positive colonies to non-selective medium (e.g., Tryptic Soy Agar with 5% sheep blood) is required for organism identification, confirmatory testing for ESBL, susceptibility testing and epidemiological typing. A lack of growth or the absence of pink, blue-turquoise-green or tan colonies on Spectra ESBL does not preclude the presence of ESBL producing organisms.

Source page: https://510kreport.com/device/K162620
Methodology: https://510kreport.com/methodology