Cleared Traditional

K945316 - PHENOBARBITAL CALIBRATORS

K945316 is the FDA 510(k) clearance for PHENOBARBITAL CALIBRATORS by Diagnostic Reagents, Inc.. It is a Class 2 Toxicology device (product code DLJ) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K945316 · Diagnostic Reagents, Inc. · Toxicology device
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Jan 1995
Decision
64d
Days
Class 2
Risk

K945316 is an FDA 510(k) clearance for the PHENOBARBITAL CALIBRATORS. 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 January 4, 1995 after a review of 64 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 Diagnostic Reagents, Inc. devices

Submission Details

510(k) Number K945316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1994
Decision Date January 04, 1995
Days to Decision 64 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
23d faster than avg
Panel avg: 87d · This submission: 64d
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 K945316.
CEDIA DAU LSD CALBIRATORS
K955813 · Microgenics Corp. · Feb 1996
CEDIA DAU PPX/METH CALIBRATOR
K951153 · Microgenics Corp. · Apr 1995
THEOPHYLLINE CALIBRATORS
K945338 · Diagnostic Reagents, Inc. · Jan 1995
PHENYTOIN CALIBRATORS
K945337 · Diagnostic Reagents, Inc. · Dec 1994
CEDIA DAU THC CALIBRATORS
K935795 · Microgenics Corp. · Apr 1994
ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS
K932548 · Roche Diagnostic Systems, Inc. · Dec 1993