# K982845: Cardiac Markers Control (Single Use)-Levels, 1,2,3, Models Number 175-1, 175-2, 175-3

- Pathway: 510(k) (Traditional)
- Applicant: More Diagnostics
- Decided: Aug 21, 1998 after 9 days
- Product code: JJT (Enzyme 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.
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
The use of control material is necessary to estimate test precision in a test system and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

Source page: https://510kreport.com/device/K982845
Methodology: https://510kreport.com/methodology