# K062972: Precinorm CK-MB and Precipath CK-MB Controls

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Oct 13, 2006 after 14 days
- Product code: JJX (Single (Specified) Analyte 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
Longest line of descent: 1 generation back to K003158 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003158: Roche Diagnostics CK-MB, Roche Diagnostics Corp. (2000) Summary page 1.

## Indications for use
Precinorm CK-MB is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. Precipath CK-MB is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. The Precinorm CK-MB and Precipath CK-MB are assayed quality control material intended for medical purposes for use in Roche test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

Source page: https://510kreport.com/device/K062972
Methodology: https://510kreport.com/methodology