# DEN170010: LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay

- Pathway: De Novo (Direct)
- Applicant: Lin-Zhi International, Inc.
- Decided: Apr 20, 2018 after 423 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K190397: Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA (2019), 0 descendants of its own

## Indications for use
The LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of carisoprodol metabolite (meprobamate) in human urine at a cutoff value of 100 ng/mL when calibrated against meprobamate. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for verification by a confirmatory method such as GC/MS, LC/MS or permitting laboratories to establish quality control procedures. The assay provides only a preliminary analytical result. A more specific alternative chemical confirmatory method (e.g., gas or liquid chromatography and mass spectrometry) must be used to obtain a confirmed analytical result. Clinical consideration and professional judgment must be exercised with any drug of abuse test, particularly when the preliminary test result is positive.

Source page: https://510kreport.com/device/DEN170010
Methodology: https://510kreport.com/methodology