# K053247: Validate Cardiac Marker (CM1) Calibration Verification Test Set

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Co.
- Decided: Jan 13, 2006 after 53 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
Longest line of descent: 5 generations back to K961828 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040277: Liquichek Cardiac Marker Control LT, Bio-Rad Laboratories, Inc. (2004) Summary page 1.
- (no number) DOCUMENT CK-MB CALoVER: named in the summary without a submission number

## Indications for use
The VALIDATE ® Cardiac Marker Calibration Verification Test Sets are used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for CK-MB and Myoglobin.

Source page: https://510kreport.com/device/K053247
Methodology: https://510kreport.com/methodology