# K132174: Multichem WBT

- Pathway: 510(k) (Abbreviated)
- Applicant: Techno-Path Manufacturing, Ltd.
- Decided: Sep 20, 2013 after 67 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: 4 generations back to K895905 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072721: Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCC, Bio-Rad, Diagnostics Grp. (2007) Summary page 1.

## Indications for use
The Multichemn WET control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The Multichemn WBT control consists of 3 different levels of control solutions prepared from human whole blood.

Source page: https://510kreport.com/device/K132174
Methodology: https://510kreport.com/methodology