Cleared Traditional

K922467 - SYNCHRON TOTAL PROTEIN TEST --MODIFIED

K922467 is an FDA 510(k) clearance for SYNCHRON TOTAL PROTEIN TEST --MODIFIED, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Chemistry device with product code CEK cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K922467 · Beckman Instruments, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Nov 1992
Decision
193d
Days
Class 2
Risk

K922467 is an FDA 510(k) clearance for the SYNCHRON TOTAL PROTEIN TEST --MODIFIED. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on November 23, 1992 after a review of 193 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1635 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K922467

510(k) Number K922467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1992
Decision Date November 23, 1992
Days to Decision 193 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 88d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEK Device Classification - Class 2, Special Controls

Product Code CEK Biuret (colorimetric), Total Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1635
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 Chemistry devices follow this clearance model.

Regulatory Peers - CEK Biuret (colorimetric), Total Protein

All 82
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K922467.
TOTAL PROTEIN TEST (TPRO)
K935174 · Em Diagnostic Systems, Inc. · Dec 1993
MICROPROTEIN REAGENT SET
K921412 · Sterling Diagnostics, Inc. · Jan 1993
OLYUMPUS TOTAL PROTEIN REAGENT
K924659 · Olympus Corp. · Dec 1992
SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000
K923267 · Em Diagnostic Systems, Inc. · Sep 1992
NOVA TOTAL PROTEIN MODULE
K923266 · Nova Biomedical Corp. · Aug 1992
OLYMPUS TOTAL PROTEIN REAGENT
K922361 · Olympus Corp. · Jul 1992