Cleared Traditional

K920749 - THC URINE CALIBRATORS

K920749 is the FDA 510(k) clearance for THC URINE CALIBRATORS by Diagnostic Reagents, Inc.. It is a Class 2 Toxicology device (product code DLJ) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K920749 · Diagnostic Reagents, Inc. · Toxicology device
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Mar 1992
Decision
28d
Days
Class 2
Risk

K920749 is an FDA 510(k) clearance for the THC URINE CALIBRATORS. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Mountain View, US). The FDA issued a Cleared decision on March 18, 1992 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - 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 Diagnostic Reagents, Inc. devices

Submission Details

510(k) Number K920749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1992
Decision Date March 18, 1992
Days to Decision 28 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 87d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DLJ Calibrators, Drug Specific
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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 - DLJ Calibrators, Drug Specific

All 93
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K920749.
ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR
K933279 · Roche Diagnostic Systems, Inc. · Aug 1993
URINE CALIBRATOR AND CONTROL
K931506 · Diagnostic Reagents, Inc. · Jul 1993
THC URINE CALIBRATORS
K923386 · Diagnostic Reagents, Inc. · Sep 1992
DIGITOXIN FPIA CALIBRATOR SET
K915464 · Sigma Diagnostics, Inc. · Jan 1992
ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS
K912048 · Roche Diagnostic Systems, Inc. · Jul 1991
ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS
K910086 · Roche Diagnostic Systems, Inc. · Jan 1991