# K132091: Multichem IA and IA Plus

- Pathway: 510(k) (Abbreviated)
- Applicant: Techno-Path Manufacturing, Ltd.
- Decided: Sep 20, 2013 after 74 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: 1 generation back to K001373 (2000). 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)
- K001373: Liquichek Immunoassay Plus Control, Model 360, 361, 362, 363, Bio-Rad (2000)

## Most influential descendants
- K162530: Multichem IA Plus (2017), 0 descendants of its own

## Indications for use
Multichem [A Plus is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analyxes listed in the package insert. The following analytes are listed in the package insert: Alpha Fetoprotein (APP) Folute Sex Hormone Binding Globulin Anti-thyroglobulin Prostate Specific Antigen, Fre T-Uptake Anti-thyroperoxidase Follicle Stimulating Hormone (ESH) Testosterone Human Chorionic Gonadotropin (8KCG) Triiodothyronine, Free (FT3) Theophylline BNP (1-32) Thyroxine, Free (P74) Troponin I CA 125 Gentamicin Thyroid Stimulating Hormone (TSH) CA 15-3 Homocysteinc Triiodothyronine, Total (M7) CA 19-9 Immunoglobulin E Thyroxine, Total (174) Carbamazepine Insulin Voiproic Acid Carcinogenic Embryonic Antigen (CEA) Luteinizing Hormone Vancomycin CK-MB Myoglobin Vitamin B12 Cortisol Parathyroid Hormone (PTI-) (1-84) 25-OH Vitamin D C-Peplide Pbenobarbital DHEA-Sul ratte Phenytoin Digoxin Progesterone Estradiol Prolactin Ferritin Prostate Specific Antigen, Total

Source page: https://510kreport.com/device/K132091
Methodology: https://510kreport.com/methodology