# K102617: Audit Microcv Cardiac Markers Linearity Set

- Pathway: 510(k) (Traditional)
- Applicant: Aalto Scientific, Ltd.
- Decided: Jan 10, 2011 after 122 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: 3 generations back to K910440 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042318: Audit Microcv General Chemistry Linearity Set, Aalto Scientific, Ltd. (2004) Summary page 1.

## Indications for use
The AuditTM MicroCVTM Cardiac Markers Linearity Set is an assayed quality control material consisting of five levels human based serum. Each level contains CKMB, Myoglobin, and Troponin I (TnI) analytes. The five levels demonstrate a linear relationship to each other for CKMB, Myoglobin, and TnI analytes. When AuditTM MicroCVTM Cardiac Markers Linearity Set is used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The product is intended for use with quantitative assays on the analyzers indicated in the labeling. The AuditTM Cardiac Markers Linearity Set is "For In Vitro Diagnostic Use Only".

Source page: https://510kreport.com/device/K102617
Methodology: https://510kreport.com/methodology