Cleared Traditional

K931506 - URINE CALIBRATOR AND CONTROL

K931506 is the FDA 510(k) clearance for URINE CALIBRATOR AND CONTROL by Diagnostic Reagents, Inc.. It is a Class 2 Toxicology device (product code DLJ) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K931506 · Diagnostic Reagents, Inc. · Toxicology device
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Jul 1993
Decision
125d
Days
Class 2
Risk

K931506 is an FDA 510(k) clearance for the URINE CALIBRATOR AND CONTROL. 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 July 28, 1993 after a review of 125 days - within the typical 510(k) review window.

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: 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 Diagnostic Reagents, Inc. devices

Submission Details

510(k) Number K931506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1993
Decision Date July 28, 1993
Days to Decision 125 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
38d slower than avg
Panel avg: 87d · This submission: 125d
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 K931506.
ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS
K932548 · Roche Diagnostic Systems, Inc. · Dec 1993
DUPONT ACA URINE METHADONE CALIBRATOR
K934144 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1993
ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR
K933279 · Roche Diagnostic Systems, Inc. · Aug 1993
THC URINE CALIBRATORS
K923386 · Diagnostic Reagents, Inc. · Sep 1992
THC URINE CALIBRATORS
K920749 · Diagnostic Reagents, Inc. · Mar 1992
DIGITOXIN FPIA CALIBRATOR SET
K915464 · Sigma Diagnostics, Inc. · Jan 1992