# K102922: Hardychrom Mrsa

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: May 4, 2011 after 215 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
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.

## Recalls of this device
- Nov 14, 2019 · Class II · Z-2298-2020: False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.
- Jul 9, 2015 · Class II · Z-2463-2015: Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot.

## Indications for use
HardyCHROMTM MRSA is a selective and differential chromogenic medium recommended for the qualitative detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in health care settings. The test is performed on anterior nares swabs from patients and healthcare workers to screen for MRSA colonization. HardyCHROMTM MRSA is not intended to diagnose MRSA infection nor to guide or monitor therapy for MRSA infections. Concomitant cultures are necessary for susceptibility testing or epidemiological typing. A negative result does not preclude MRSA nasal colonization.

Source page: https://510kreport.com/device/K102922
Methodology: https://510kreport.com/methodology