# K022851: PH and Amines External Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corp.
- Decided: Sep 27, 2002 after 31 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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. The FDA summary names no predicate by number.

## Indications for use
The pH and Amines External Control Set is intended for use with the QuickVueB Advance pH and Amines test and the FemExarna pH and Amines Testcard”. These controls are intended for use as external controls to aid in the interpretation of positive and negative test results and verify test and operator performance. The pH and Amines External Control Set is for use by healthcare professionals.

Source page: https://510kreport.com/device/K022851
Methodology: https://510kreport.com/methodology