Cleared Traditional

K955813 - CEDIA DAU LSD CALBIRATORS

K955813 is the FDA 510(k) clearance for CEDIA DAU LSD CALBIRATORS by Microgenics Corp.. It is a Class 2 Toxicology device (product code DLJ) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K955813 · Microgenics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
45d
Days
Class 2
Risk

K955813 is an FDA 510(k) clearance for the CEDIA DAU LSD CALBIRATORS. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on February 9, 1996 after a review of 45 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 K955813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1995
Decision Date February 09, 1996
Days to Decision 45 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
42d faster than avg
Panel avg: 87d · This submission: 45d
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 K955813.
CEDIA DIGOXIN CALIBRATORS
K972433 · Boehringer Mannheim Corp. · Jul 1997
ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR
K962280 · Roche Diagnostic Systems, Inc. · Aug 1996
ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20
K961726 · Roche Diagnostic Systems, Inc. · Jul 1996
CEDIA DAU PPX/METH CALIBRATOR
K951153 · Microgenics Corp. · Apr 1995
THEOPHYLLINE CALIBRATORS
K945338 · Diagnostic Reagents, Inc. · Jan 1995
PHENOBARBITAL CALIBRATORS
K945316 · Diagnostic Reagents, Inc. · Jan 1995