# K131993: Multichem U

- Pathway: 510(k) (Abbreviated)
- Applicant: Techno-Path Manufacturing, Ltd.
- Decided: Oct 15, 2013 after 109 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 K971954 (1997). 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)
- K020817: Liquichek Urine Chemistry Control, Bio-Rad Laboratories, Inc. (2002) Summary page 1.

## Indications for use
Multichemn U is intended for use as an assayed urine quality control to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. Two levels of Controls (Level I and Level 2) are supplied in liquid form. The following analytes are listed in the package insert: Amylase, Calcium, Chloride, Creatinine Enzymatic, Creatinine Picrate, Glucose, Magnesium, Microalbumin, Phosphorous, Potassium, Sodium, Urea Nitrogen, Uric Acid, Urinary Protein.

Source page: https://510kreport.com/device/K131993
Methodology: https://510kreport.com/methodology