Cleared Traditional

K904413 - CEDIA(TM) PHENOBARBITAL ASSAY

K904413 is the FDA 510(k) clearance for CEDIA(TM) PHENOBARBITAL ASSAY by Microgenics Corp.. It is a Class 2 Toxicology device (product code LAF) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K904413 · Microgenics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1990
Decision
40d
Days
Class 2
Risk

K904413 is an FDA 510(k) clearance for the CEDIA(TM) PHENOBARBITAL ASSAY. Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on November 5, 1990 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - 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 K904413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1990
Decision Date November 05, 1990
Days to Decision 40 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 87d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LAF Gas Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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 - LAF Gas Chromatography, Methamphetamine

All 31
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K904413.
QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065)
K972556 · Phamatech · Sep 1997
ACCUSIGN MET/BIOSIGN MET
K961249 · Princeton BioMeditech Corp. · Apr 1996
TENONE(TM) METHAMPHETAMINE
K910043 · Diagnostic Products Corp. · Feb 1991
COAT-A-COUNT METHAMPHETAMIN #TKMA1
K885071 · Diagnostic Products Corp. · Jan 1989