Cleared Traditional

K944076 - CX(TM) BENZODIAZEPINE(BENZ) REAGENT FOR...

K944076 is an FDA 510(k) clearance for CX(TM) BENZODIAZEPINE(BENZ) REAGENT FOR..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Toxicology device with product code JXM cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K944076 · Beckman Instruments, Inc. · Toxicology device
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Nov 1994
Decision
139d
Days
Class 2
Risk

K944076 is an FDA 510(k) clearance for the CX(TM) BENZODIAZEPINE(BENZ) REAGENT FOR SYCHRON CX SYS. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on November 21, 1994 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3170 - 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 - K944076

510(k) Number K944076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1994
Decision Date November 21, 1994
Days to Decision 139 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
52d slower than avg
Panel avg: 87d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXM Device Classification - Class 2, Special Controls

Product Code JXM Enzyme Immunoassay, Benzodiazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3170
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 - JXM Enzyme Immunoassay, Benzodiazepine

All 75
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K944076.
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K950427 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1995
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K942795 · Microgenics Corp. · Aug 1994
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K934869 · Solarcare Technologies Corp,Inc. · Nov 1993