Cleared Traditional

DUPONT DIMENSION TOTAL PROTEIN METHOD (K950920) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K950920 · Dupont Medical Products · Chemistry device
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Aug 1995
Decision
163d
Days
Class 2
Risk

K950920 is an FDA 510(k) clearance for the DUPONT DIMENSION TOTAL PROTEIN METHOD. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Dupont Medical Products (Wilmington, US). The FDA issued a Cleared decision on August 11, 1995 after a review of 163 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 Dupont Medical Products devices

Submission Details

510(k) Number K950920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1995
Decision Date August 11, 1995
Days to Decision 163 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 88d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 30
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K950920.
URINARY/CEREBROSPINAL FLUID PROTEIN
K934841 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1994
TOTAL PROTEIN TEST (TPRO)
K935174 · Em Diagnostic Systems, Inc. · Dec 1993
OLYUMPUS TOTAL PROTEIN REAGENT
K924659 · Olympus Corp. · Dec 1992
SYNCHRON TOTAL PROTEIN TEST --MODIFIED
K922467 · Beckman Instruments, Inc. · Nov 1992
SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000
K923267 · Em Diagnostic Systems, Inc. · Sep 1992
OLYMPUS TOTAL PROTEIN REAGENT
K922361 · Olympus Corp. · Jul 1992