Cleared Traditional

ACS PHENOBARBITAL (K953021) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K953021 · Ciba Corning Diagnostics Corp. · Toxicology device
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Dec 1995
Decision
165d
Days
Class 2
Risk

K953021 is an FDA 510(k) clearance for the ACS PHENOBARBITAL. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on December 11, 1995 after a review of 165 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ciba Corning Diagnostics Corp. devices

Submission Details

510(k) Number K953021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1995
Decision Date December 11, 1995
Days to Decision 165 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
78d slower than avg
Panel avg: 87d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 - DIS Enzyme Immunoassay, Barbiturate

All 41
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K953021.
ROCHE COBAS INTEGRA SERUM BARBITURATES
K991440 · Roche Diagnostics Corp. · Jun 1999
MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
K983698 · Roche Diagnostic Systems, Inc. · May 1999
ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN
K982551 · Roche Diagnostic Systems, Inc. · Aug 1998
AXSYM BARBITURATES II U
K951253 · Abbott Laboratories · May 1995
URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950137 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1995
EMIT IIC BARBITURATE ASSAY
K935116 · Syva Co. · Feb 1995