# K062593: Cardiac Markers Control and Calibration Verification Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Compass Bioscience
- Decided: Nov 22, 2006 after 82 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. The FDA summary names its predicate without a number.
- (no number) Triage® Profiler S.O.B. (Shortness of Breath) Control: named in the summary without a submission number
- (no number) Triage® Profiler S.O.B. (Shortness of Breath) Calibration Verification Controls: named in the summary without a submission number

## Indications for use
The Compass Bioscience Cardiac Markers Controls are to be used as a quality control material to assess the accuracy and precision of laboratory test methods used to measure the antigens and enzymes contained in the control. It is intended to validate the measurement of these analytes in patient samples. Three levels of control are provided to allow the performance of the analyte test methods to be monitored within the clinically significant range. The Compass Bioscience Cardiac Marker Calibration Verification Control Set is used to verify the calibration of various test methods over the measurable range of the test.

Source page: https://510kreport.com/device/K062593
Methodology: https://510kreport.com/methodology