Cleared Traditional

K914885 - BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROT...

K914885 is an FDA 510(k) clearance for BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROT..., 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 92-day FDA review.

K914885 · Beckman Instruments, Inc. · Chemistry device
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Jan 1992
Decision
92d
Days
Class 2
Risk

K914885 is an FDA 510(k) clearance for the BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST. 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 January 30, 1992 after a review of 92 days - within the typical 510(k) review window.

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 - K914885

510(k) Number K914885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1991
Decision Date January 30, 1992
Days to Decision 92 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
4d slower than avg
Panel avg: 88d · This submission: 92d
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 K914885.
OLYMPUS TOTAL PROTEIN REAGENT
K922361 · Olympus Corp. · Jul 1992
WAKO AUTOKIT MICRO TP
K920531 · Wako Chemicals USA, Inc. · Jul 1992
MICROPROTEIN-PR
K915380 · Sigma Diagnostics, Inc. · Feb 1992
TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZE
K913978 · Beckman Instruments, Inc. · Oct 1991
ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13
K912810 · Em Diagnostic Systems, Inc. · Jul 1991
SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420
K905661 · Em Diagnostic Systems, Inc. · Jan 1991