# K131992: Multichem P

- Pathway: 510(k) (Abbreviated)
- Applicant: Techno-Path Manufacturing, Ltd.
- Decided: Sep 25, 2013 after 89 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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: 2 generations back to K011494 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022991: Liquichek Immunology Control Level 1, 2, and 3-1 ML, Model 591, 592, 593; Level 1, 2, and 3-3 ML, Model 594, 595, 596, Bio-Rad (2002) Summary page 1.

## Indications for use
Multichem P is intended for use as a single level assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The following analytes are listed in the package insert: Alpha- I Acidglycoprotein Alpha-I Antitiypsin Apolipoprotein Al (APO Al) Apolipoprotein B (APO B) Beta-2 Microglobulin- Ceruloplasmin Complement C3 Complement C4 C-Reactive Protein Haptoglobin Immunoglobulin A Immunoglobulin G Immunoglobulin M Prealbumnin Rheumatoid Factor (1(F) Transferrin

Source page: https://510kreport.com/device/K131992
Methodology: https://510kreport.com/methodology