# K190397: Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA

- Pathway: 510(k) (Traditional)
- Applicant: Immunalysis Corporation
- Decided: Nov 15, 2019 after 269 days
- Product code: QBK (Meprobamate Test System)
- Device class: 2
- Regulation: 21 CFR 862.3590
- 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 DEN170010 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170010: LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay, Lin-Zhi International, Inc. (2018) Summary page 4.

## Indications for use
The Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is a homogeneous enzyme immunoassay for the qualitative analysis of carisoprodol metabolite, Meprobamate, at a cutoff of 280 ng/mL in human urine. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only. The Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography / Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K190397
Methodology: https://510kreport.com/methodology