# K964015: Indicard Test

- Pathway: 510(k) (Traditional)
- Applicant: Litmus Concepts, Inc.
- Decided: Jun 19, 1997 after 255 days
- Product code: MJM (Dna Probe, Gardnerella Vaginalis)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K993732: Bvblue (2000), 0 descendants of its own

## Indications for use
The Indicard™ test is an enzyme activity test for use in the detection of Gardnerella vaginalis Proline IminoPeptidase (PIP) activity in vaginal fluid specimens from patients suspected of having vaginosis. The Indicard™ test is indicated for professional use only and may be used at point of care. It is not intended for home use.

Source page: https://510kreport.com/device/K964015
Methodology: https://510kreport.com/methodology