# K980514: Chemtrak Platinum Comprehensive Liquid Assayed Chemistry and TDM Control Level 1, Model AP11001, Level 2, Model AP22002

- Pathway: 510(k) (Traditional)
- Applicant: Medical Analysis Systems, Inc.
- Decided: Mar 4, 1998 after 22 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
chemTRAK® Platinum Comprehensive Liquid Assayed Chemistry and TDM Control is a bovine based quality control material used in various general chemistry and immunoassay assays. The product is intended for use as a consistent test sample of known concentrations that is assayed along with patient serum specimens when assaying for any of the listed constituents. The Clinician can compare recovered values over an extended period of time as a means of evaluating analytical precision, as well as reagent and instrument performance.

Source page: https://510kreport.com/device/K980514
Methodology: https://510kreport.com/methodology