Cleared Traditional

K210212 - Psychemedics Homogeneous Enzyme Immunoa...

K210212 is an FDA 510(k) clearance for Psychemedics Homogeneous Enzyme Immunoa..., manufactured by Psychemedics Corporation. The device is a Class 2 Toxicology device with product code LAF cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K210212 · Psychemedics Corporation · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
322d
Days
Class 2
Risk

K210212 is an FDA 510(k) clearance for the Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair. Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by Psychemedics Corporation (Culver City, US). The FDA issued a Cleared decision on December 15, 2021 after a review of 322 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 Psychemedics Corporation devices

FDA 510(k) Submission Details - K210212

510(k) Number K210212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2021
Decision Date December 15, 2021
Days to Decision 322 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
235d slower than avg
Panel avg: 87d · This submission: 322d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LAF Device Classification - Class 2, Special Controls

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 32
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K210212.
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay
K203647 · Immunalysis Corporation · Dec 2021
Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers
K201442 · Diatron Group · Jul 2020
Rapid Tox Cup II
K170222 · American Bio Medica Corp. · Aug 2017
Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K153693 · Immunalysis Corporation · Mar 2016
Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)
K150096 · Healgen Scientific, LLC · Mar 2015
LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
K131652 · Lin-Zhi International, Inc. · Mar 2014