Cleared Traditional

K935794 - CEDIA DAU 4-DRUG CUTOFF CALIBRATOR

K935794 is the FDA 510(k) clearance for CEDIA DAU 4-DRUG CUTOFF CALIBRATOR by Microgenics Corp.. It is a Class 2 Toxicology device (product code DKB) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K935794 · Microgenics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
49d
Days
Class 2
Risk

K935794 is an FDA 510(k) clearance for the CEDIA DAU 4-DRUG CUTOFF CALIBRATOR. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on January 25, 1994 after a review of 49 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 K935794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1993
Decision Date January 25, 1994
Days to Decision 49 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
38d faster than avg
Panel avg: 87d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKB Calibrators, Drug Mixture
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 - DKB Calibrators, Drug Mixture

All 77
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K935794.
CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB
K936028 · Microgenics Corp. · Mar 1994
URINE CALIBRATORS AND CONTROLS MODIFICATION
K935101 · Diagnostic Reagents, Inc. · Jan 1994
CEDIA DAU 5-DRUG CALIBRATORS
K935792 · Microgenics Corp. · Jan 1994
ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK
K935550 · Roche Diagnostic Systems, Inc. · Jan 1994
ABUSCREEN ONLINE(R) CALIBRATORS
K931124 · Roche Diagnostic Systems, Inc. · Aug 1993
ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
K932753 · Roche Diagnostic Systems, Inc. · Jul 1993