Cleared Traditional

K953021 - ACS PHENOBARBITAL

K953021 is an FDA 510(k) clearance for ACS PHENOBARBITAL, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 165-day FDA review.

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

FDA 510(k) Submission Details - K953021

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.

DIS Device Classification - Class 2, Special Controls

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 74
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K953021.
ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN BAR/BZO/MTD
K961010 · Princeton BioMeditech Corp. · Jun 1996
BARBITURATE SERUM TOX EIA ASSAY
K960664 · Diagnostic Reagents, Inc. · May 1996
BARBITURATE EIA ESSAY (MODIFICATION)
K955928 · Diagnostic Reagents, Inc. · Mar 1996
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