Cleared Traditional

K012109 - DRI ECSTASY URINE CALIBRATORS

K012109 is the FDA 510(k) clearance for DRI ECSTASY URINE CALIBRATORS by Microgenics Corp.. It is a Class 2 Toxicology device (product code DLJ) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K012109 · Microgenics Corp. · Toxicology device
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Aug 2001
Decision
52d
Days
Class 2
Risk

K012109 is an FDA 510(k) clearance for the DRI ECSTASY URINE CALIBRATORS. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on August 27, 2001 after a review of 52 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 Microgenics Corp. devices

Submission Details

510(k) Number K012109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2001
Decision Date August 27, 2001
Days to Decision 52 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
35d faster than avg
Panel avg: 87d · This submission: 52d
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 K012109.
CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K021449 · Lin-Zhi International, Inc. · Jun 2002
EMIT 2000 VANCOMYCIN CALIBRATORS
K020845 · Dade Behring, Inc. · May 2002
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K020769 · Lin-Zhi International, Inc. · Apr 2002
CYCLOSPORINE CALIBRATOR
K011112 · Dade Behring, Inc. · Jul 2001
SYNCHRON SYSTEMS DRUG CALIBRATOR 2
K993473 · Beckman Coulter, Inc. · Nov 1999
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS
K993022 · Beckman Coulter, Inc. · Nov 1999