# K170586: Strep B Carrot Broth One-Step

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: May 22, 2017 after 83 days
- Product code: PQZ (Gbs Culture Media, Selective And Differential)
- Device class: 1
- Regulation: 21 CFR 866.2360
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K871447 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871447: Todd Hewitt W/Cna (Lim Broth), Remel Co. (1987) Summary page 4.

## Recalls of this device
- Oct 6, 2020 · Class III · Z-0441-2021: Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expiration date of 2020-11-10
- Apr 20, 2020 · Class II · Z-2051-2020: Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patie

## Indications for use
Strep B Carrot Broth™ One-Step is a selective and differential medium which is intended for the detection of Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. The medium is used as an aid in the qualitative determination of GBS colonization in pregnant women. The color change reaction from white to orange is representative of a positive result for presence of GBS. The medium requires 24 hours of incubation but positive results can be interpreted as early as 16 hours. Due to the properties of Strep B Carrot Broth™ One-Step, non-hemolytic GBS cannot be detected by the medium’s color change and require subculture for identification. Any presumptive negative indicated by lack of color change at the end of the incubation period must be subcultured to a non-selective medium (e.g. Tryptic Soy Agar with 5% Sheep Blood) to confirm absence of GBS. Subculture must also be performed to recover isolates for conducting susceptibility testing as recommended for penicillin-allergic women.

Source page: https://510kreport.com/device/K170586
Methodology: https://510kreport.com/methodology