Cleared Traditional

K973122 - QUICKSCREEN ONE STEP THC SCREENING TEST

K973122 is the FDA 510(k) clearance for QUICKSCREEN ONE STEP THC SCREENING TEST by Phamatech. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K973122 · Phamatech · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
36d
Days
Class 2
Risk

K973122 is an FDA 510(k) clearance for the QUICKSCREEN ONE STEP THC SCREENING TEST. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on September 25, 1997 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Phamatech devices

Submission Details

510(k) Number K973122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1997
Decision Date September 25, 1997
Days to Decision 36 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
51d faster than avg
Panel avg: 87d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 - LDJ Enzyme Immunoassay, Cannabinoids

All 85
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K973122.
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
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K955677 · Beckman Instruments, Inc. · Apr 1996