# K061683: Tina-Quant Myoglobin Gen.2 Test System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jul 21, 2006 after 36 days
- Product code: DDR (Myoglobin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K902154 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972513: Tinaquant Myoglobin Assay, Boehringer Mannheim Corp. (1997) Summary page 1.

## Most influential descendants
- K123785: Diazyme Myoglobin; Assay, Calibrator Set, Control Set (2013), 0 descendants of its own

## Recalls of this device
- Jul 2, 2019 · Class II · Z-2445-2019: The firm conducted internal investigations that confirmed customer complaints of quality control (QC) imprecision and calibration failures for the Tina-quant Myoglobin Gen.2 assay (catalog number 0458

## Indications for use
The Tina-Quant ® Myoglobin Gen.2 Test System is an immunoturbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease. C.f.a.s. (Calibrator for automated systems) Myoglobin is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.

Source page: https://510kreport.com/device/K061683
Methodology: https://510kreport.com/methodology