# K992976: K-Assay Myoglobin Assay, K-Assay Myoglobin Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Nov 1, 1999 after 59 days
- Product code: DDR (Myoglobin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5680
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The K-ASSAY Myoglobin Assay is intended to be used for the quantitative determination of Myoglobin in serum by latex particle enhanced immunoturbidimetric assay. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease. The K-ASSAY Myoglobin Multi-Calibrator is intended to be used for the calibration of the K-ASSAY Myoglobin Assay.

Source page: https://510kreport.com/device/K992976
Methodology: https://510kreport.com/methodology