# K162530: Multichem IA Plus

- Pathway: 510(k) (Abbreviated)
- Applicant: Techno-Path Manufacturing
- Decided: Mar 31, 2017 after 203 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 K001373 (2000). 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)
- K132091: Multichem IA and IA Plus, Techno-Path Manufacturing, Ltd. (2013) Summary page 5.

## Indications for use
For In Vitro Diagnostic use only. Multichem IA Plus is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Source page: https://510kreport.com/device/K162530
Methodology: https://510kreport.com/methodology