# K981933: Urichemtrak Liquid Assayed Control Levels 1 and 2

- Pathway: 510(k) (Traditional)
- Applicant: Medical Analysis Systems, Inc.
- Decided: Jun 29, 1998 after 27 days
- Product code: JJW (Urinalysis Controls (Assayed And Unassayed))
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K991917: Osteomark NTX Point of Care (Poc) Control Set (1999), 0 descendants of its own

## Indications for use
UrichemTRAK Liquid Assayed Control is a human urine based quality control material used in various general chemistry assays. The product is intended for use as a consistent test sample of known concentrations that is assayed along with patient urine specimens when performing urine chemistry assays. 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/K981933
Methodology: https://510kreport.com/methodology