# K210511: InTray GC

- Pathway: 510(k) (Traditional)
- Applicant: Biomed Diagnostics Incorporated
- Decided: Oct 20, 2021 after 239 days
- Product code: JTY (Culture Media, For Isolation Of Pathogenic Neisseria)
- Device class: 2
- Regulation: 21 CFR 866.2410
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K993033 (1999). 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)
- K993033: Intray GC, Biomed Diagnostics, Inc. (1999) Summary page 4.

## Indications for use
The InTray GC is a microbiological device intended to differentiate and support the growth of pathogenic Neisseria gonorrhoeae when incubated at 35°C for 24-72 hours. Inoculated samples can optionally be pre-incubated prior to transport when pre-incubated at 35°C for 24 hours. Subsequent transport, of the pre-incubated specimen under controlled room temperature (18 to 25°C), is supported out to 72 hours.

Source page: https://510kreport.com/device/K210511
Methodology: https://510kreport.com/methodology