# K190553: HardyCHROM CRE

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Apr 29, 2019 after 55 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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 3.

## Recalls of this device
- May 6, 2025 · Class II · Z-2041-2025: Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.

## Indications for use
HardyCHROM™ CRE is a selective and differential chromogenic agar medium intended for the qualitative and presumptive detection from stool specimens of Escherichia coli that are non- susceptible to carbapenems as pink colonies and KES (Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Enterobacter cloacae complex, and Serratia marcescens) that are non-susceptible to carbapenems as blue colonies. HardyCHROM CRE is intended as an aid in the detection, identification of colonization and control of these bacteria in a healthcare setting. HardyCHROM™ CRE is not intended to diagnose infection or guide therapy. Results can be interpreted after incubation for 18-24 hours. Subculture to non-selective medium is required for confirming identification, antimicrobial susceptibility testing and epidemiological typing. A lack of growth or the absence of pink or blue colonies on HardyCHROM™ CRE does not preclude the presence of Escherichia coli and KES that are non-susceptible to carbapenems.

Source page: https://510kreport.com/device/K190553
Methodology: https://510kreport.com/methodology