# K973358: Myoglobin Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Oct 6, 1997 after 28 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 K902154 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902154: NA Latex Myoglobin Test, Behring Diagnostics, Inc. (1990) Summary page 1.

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

## Indications for use
The Myoglobin Control Set are used for monitoring accuracy and precision of the Boehringer Mannheim Tinaquant Myoglobin assay.

Source page: https://510kreport.com/device/K973358
Methodology: https://510kreport.com/methodology