Cleared Traditional

K190397 - Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA (FDA 510(k) Clearance)

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190397 · Immunalysis Corporation · Toxicology device
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Nov 2019
Decision
269d
Days
Class 2
Risk

K190397 is an FDA 510(k) clearance for the Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA. Classified as Meprobamate Test System (product code QBK), Class II - Special Controls.

Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on November 15, 2019 after a review of 269 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3590 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Immunalysis Corporation devices

Submission Details

510(k) Number K190397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2019
Decision Date November 15, 2019
Days to Decision 269 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
182d slower than avg
Panel avg: 87d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QBK Meprobamate Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3590
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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.