# K971060: Precinorm TDM Controls

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jul 7, 1997 after 105 days
- Product code: DIF (Drug Mixture Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- 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 K912455 (1991). 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)
- K912455: Dade Iac-X Comprehensive Immunoassay Control, Baxter Healthcare Corp (1991) Summary page 1.

## Indications for use
Precinorm® TDM is a triple range lyophilised control material based on human serum. Precinorm® TDM is used for monitoring accuracy or precision.

Source page: https://510kreport.com/device/K971060
Methodology: https://510kreport.com/methodology