# K961912: Qualitrol, (Alfa Fetoprotein) Afp Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Consolidated Technologies, Inc.
- Decided: Aug 15, 1996 after 90 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Clinical laboratories. performing quantitative or semi-quantitative tests to determine alpha fetoprotein CAFP) in patient specimen and desiring to use the quality control material that 1s not provided with the kit used for such measurement. may use Qualitrol AFP Control Set as an alternative. Compattibility among the test reagents and Qualitrol AFP Control Set needs to be established prior to such a use.

Source page: https://510kreport.com/device/K961912
Methodology: https://510kreport.com/methodology