# K160512: HardyCHROM ESBL

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Nov 15, 2016 after 265 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: 2 generations back to K972359 (1997). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122187: Vreselect Culture Medium, Bio-Rad (2012) Summary page 4.

## Most influential descendants
- K162620: Remel Spectra ESBL (2017), 0 descendants of its own

## Indications for use
HardyCHROM ESBL is a selective and differential chromogenic medium which is intended for the qualitative and presumptive detection from stool specimens of: 1) Enterobacteriaceae that are potentially non-susceptible to ceftazidime and cefpodoxime; and 2) Extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli, Klebsiella pneumoniae and Klebsiella oxytoca. The test is performed on stool specimens from patients at risk of harboring Enterobacteriaceae that are non-susceptible to 3rd generation cephalosporins or ESBL-producing E. coli, K. pneumoniae and K. oxytoca, and is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. HardyCHROM ESBL is not intended to diagnose infection or to guide or monitor treatment for infections. Results can be interpreted after incubation for 18-24 hours. Subculture to non-selective medium is required for confirming identification, susceptibility testing and epidemiological typing. A lack of growth or the absence of pink, blue or yellow/gold colonies on HardyCHROM ESBL does not preclude the presence of Enterobacteriaceae that are non-susceptible to 3rd generation cephalosporins or ESBL producing organisms.

Source page: https://510kreport.com/device/K160512
Methodology: https://510kreport.com/methodology