# K972080: Qualitrol DHP Immunoassay Control Levels 1,2 and 3, Conformancee MCC-Ligand Control Levels 1, 2 and 3

- Pathway: 510(k) (Traditional)
- Applicant: Consolidated Technologies, Inc.
- Decided: Jun 18, 1997 after 15 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 Ilaboratories, performing immunoassays for drugs, hormones and proteins on automated immunoassay systems may use Qualitrol Immunoassay DHP Control or CONFORMANCE MCC-Ligand Control routinely as a means of estimating precision and monitoring test system performance, provided: (a) the above mentioned controls, provided as a set (Levels 1, 2 and 3) are used as an adjunct to primary control procedure recommended by the manufacturer of immunoassay systems. (b) above mentioned controls are used in accordance with the quality control requirements of regulatory and/or accrediting organizations and laboratory's quality control goals; (c) above mentioned controls are validated for use with the specific immunoassay test system being used by the clinical laboratory. These controls have been assayed with AXSYM, IMx-and TDX systems manufactured by Abbott Laboratories (Abbott Park, USA). The expected values, for these systems, are included in the package insert. The controls may be used as assayed controls for the stated indication for use when measurements are made with above-mentioned immunoassay systems.

Source page: https://510kreport.com/device/K972080
Methodology: https://510kreport.com/methodology