Cleared Traditional

K944075 - CX(TM) BARBITURATES(BARB) REAGENT FOR S...

K944075 is an FDA 510(k) clearance for CX(TM) BARBITURATES(BARB) REAGENT FOR S..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K944075 · Beckman Instruments, Inc. · Toxicology device
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Dec 1994
Decision
177d
Days
Class 2
Risk

K944075 is an FDA 510(k) clearance for the CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYST. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on December 29, 1994 after a review of 177 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K944075

510(k) Number K944075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1994
Decision Date December 29, 1994
Days to Decision 177 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
90d slower than avg
Panel avg: 87d · This submission: 177d
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 71
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K944075.
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
CEDIA DAU BARBITURATE ASSAY
K945344 · Microgenics Corp. · Dec 1994
CEDIA DAU BARBITURATE ASSAY
K942436 · Microgenics Corp. · Aug 1994
CEDIA(R) DAU BARBITURATE ASSAY, MODIFICATION
K942404 · Microgenics Corp. · Jul 1994