# K962718: Femexam Testcard

- Pathway: 510(k) (Traditional)
- Applicant: Litmus Concepts, Inc.
- Decided: Feb 7, 1997 after 210 days
- Product code: CEN (Dye-Indicator, Ph (Urinary, Non-Quantitative))
- Device class: 1
- Regulation: 21 CFR 862.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K040008: Quickvue Advance PH and Amines GLL Test (2004), 0 descendants of its own
- K993732: Bvblue (2000), 0 descendants of its own

## Indications for use
The FemExam® TestCard™ contains two qualitative, colorimetric tests for use in the characterization of a vaginal fluid sample: (1) a pH test that differentiates vaginal fluid pH less than pH 4.7 from vaginal fluid pH equal to or greater than pH 4.7; and (2) a test that detects alkali volatilizable amines in vaginal fluid.

Source page: https://510kreport.com/device/K962718
Methodology: https://510kreport.com/methodology