# K040008: Quickvue Advance PH and Amines GLL Test

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corp.
- Decided: Apr 29, 2004 after 118 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
Longest line of descent: 1 generation back to K962718 (1997). 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)
- K962718: Femexam Testcard, Litmus Concepts, Inc. (1997) Summary page 2.

## Indications for use
The QuickVue Advance pH and Amines gil test contains two calorimetric tests intended for the qualitative detection of elevated vaginal fluid pH (pH > 4.7) and the presence of volatile vaginal fluid amines. The test is intended for use by health care professionals as an aid in the diagnosis of bacterial vaginosis.

Source page: https://510kreport.com/device/K040008
Methodology: https://510kreport.com/methodology