Cleared Traditional

K203647 - SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay (FDA 510(k) Clearance)

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

K203647 · Immunalysis Corporation · Toxicology device
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Dec 2021
Decision
373d
Days
Class 2
Risk

K203647 is an FDA 510(k) clearance for the SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay. Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on December 22, 2021 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - 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. Elevated predicate reliance profile. 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 K203647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2020
Decision Date December 22, 2021
Days to Decision 373 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
286d slower than avg
Panel avg: 87d · This submission: 373d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LAF Gas Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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.

Regulatory Peers - LAF Gas Chromatography, Methamphetamine

All 48
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K203647.
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