DeviceClearance

Product code QBK— Clinical Toxicology

Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA

Classification name
Meprobamate Test System
Device class
Class 2
Regulation
21 CFR 862.3590
Advisory panel
Clinical Toxicology
Total cleared
2
First cleared
Most recent

FDA classification definition

“A meprobamate test system is a device intended to measure meprobamate in human specimens. Measurements obtained by this device are used to detect the presence of meprobamate to diagnose the use or overdose of meprobamate or structurally-related drug compounds (e.g., prodrugs).”

— U.S. Food and Drug Administration, device classification record for product code QBK under 21 CFR 862.3590, via openFDA

Market context for product code QBK

FDA has cleared 2 devices under product code QBK between 2018 and 2019, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QBK

Recent clearances under product code QBK

Data sourced from openFDA. This site is unofficial and independent of the FDA.