Meprobamate Test System
The Meprobamate Test System is an in vitro diagnostic device intended to measure meprobamate in human specimens to detect the presence of meprobamate or structurally-related prodrug compounds, used in the diagnosis of use or overdose of these substances. It is classified as a Class 2 device under regulation 862.3590, requiring 510(k) premarket notification and eligible for third-party review, falling within the Clinical Toxicology (TX) medical specialty. The product code is QBK. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QBK
- Device Class
- FDA class 2
- Regulation Number
- 862.3590
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K190397 | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA | Nov 15, 2019 | Substantially Equivalent | Immunalysis Corporation |
| DEN170010 | LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay | Apr 20, 2018 | Unknown | Lin-Zhi International, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.