Cleared Traditional

K946210 - PHENOBARBITAL ENZYME IMMUNOASSAY

K946210 is the FDA 510(k) clearance for PHENOBARBITAL ENZYME IMMUNOASSAY by Diagnostic Reagents, Inc.. It is a Class 2 Toxicology device (product code DLZ) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K946210 · Diagnostic Reagents, Inc. · Toxicology device
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Feb 1995
Decision
51d
Days
Class 2
Risk

K946210 is an FDA 510(k) clearance for the PHENOBARBITAL ENZYME IMMUNOASSAY. Classified as Enzyme Immunoassay, Phenobarbital (product code DLZ), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Mountain View, US). The FDA issued a Cleared decision on February 10, 1995 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3660 - 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 K946210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1994
Decision Date February 10, 1995
Days to Decision 51 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
36d faster than avg
Panel avg: 87d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DLZ Enzyme Immunoassay, Phenobarbital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3660
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 - DLZ Enzyme Immunoassay, Phenobarbital

All 31
Devices cleared under the same product code (DLZ) and FDA review panel - the closest regulatory comparables to K946210.
IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5
K000012 · Diagnostic Products Corp. · Mar 2000
ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS
K993031 · Syva Co. · Jan 2000
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
K984288 · Ortho-Clinical Diagnostics, Inc. · Jan 1999
IL TEST PHENOBARBITAL CALIBRATORS
K943981 · Instrumentation Laboratory CO · Jan 1995
PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS
K935568 · Baxter Diagnostics, Inc. · Mar 1994
EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS
K913190 · Syva Co. · Aug 1991