# K050352: IN-Vitro Diagnostic Vaginitis Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Ameritek Research, LLC
- Decided: Sep 1, 2005 after 202 days
- Product code: JTO (Discs, Strips And Reagents, Microorganism Differentiation)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: none
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
FemLab is a biochemical assay intended for use as a screening test for nitrites, blood, protein, leukocytes, and proline-iminopeptidase in vaginal fluid samples, and also to measure vaginal fluid pH. It is indicated for use as an aid in the presumptive diagnosis of vaginitis or urethritis and should be used in conjunction with other laboratory tests such as Gram stain, microscopic examination, culture and KOH test. The FemLab Vaginitis Test Kit is for professional and laboratory use only.

Source page: https://510kreport.com/device/K050352
Methodology: https://510kreport.com/methodology