# K993723: Cardiasure Cardiac Markers Control

- Pathway: 510(k) (Traditional)
- Applicant: Quantimetrix Corp.
- Decided: Nov 23, 1999 after 20 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. The FDA summary names its predicate without a number.
- (no number) Liquichek™ Cardiac Markers Control: named in the summary without a submission number

## Indications for use
The Quantimetrix Cardiasure Control is to be used as a quality control material to assess the accuracy and precision of laboratory test methods used to measure the specific serum analytes contained in the control material in order to validate the measurernent of these analytes in patient samples. Quality Control materials that have known component concentrations are an integral part of diagnostic procedures. Daily monitoring of control values establishes intra- and interlaboratory parameters for accuracy and precision of the test method. Three levels of control are provided to allow the performance of the test methods to be monitored within the clinically significant ranges.

Source page: https://510kreport.com/device/K993723
Methodology: https://510kreport.com/methodology