# K173903: Granada Medium

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Mar 22, 2018 after 90 days
- Product code: PQZ (Gbs Culture Media, Selective And Differential)
- Device class: 1
- Regulation: 21 CFR 866.2360
- 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 K881577 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163042: chromID Strepto B agar, bioMerieux, Inc. (2017) Summary page 4.

## Indications for use
Granada Medium is a selective and differential agar which is intended for the qualitative detection of Group B Streptococcus (GBS) from LIM Broth enrichment cultures of vaginal/rectal swabs from antepartum women following 18-24 hours of incubation. Recovery of orange colored colonies on Granada Medium is a positive result for presence of β-hemolytic GBS. Results can be interpreted after18-24 hours of anaerobic incubation. Due to the properties of Granada Medium, white colonies recovered on Granada Medium must undergo additional testing to confirm absence of GBS. Subculture of GBS colonies must be performed for conducting susceptibility testing as recommended for penicillin- allergic women. A lack of growth or the absence of orange colonies on Granada Medium does not preclude the presence of GBS. Granada Medium is not intended to diagnose infection, or to guide or monitor treatment for infections.

Source page: https://510kreport.com/device/K173903
Methodology: https://510kreport.com/methodology