Cleared Traditional

K973108 - TOTAL PROTEIN (MICRO) ASSAY

K973108 is the FDA 510(k) clearance for TOTAL PROTEIN (MICRO) ASSAY by Diagnostic Chemicals , Ltd.. It is a Class 2 Chemistry device (product code CEK) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K973108 · Diagnostic Chemicals , Ltd. · Chemistry device
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Mar 1998
Decision
195d
Days
Class 2
Risk

K973108 is an FDA 510(k) clearance for the TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E.I., CA). The FDA issued a Cleared decision on March 2, 1998 after a review of 195 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 Diagnostic Chemicals , Ltd. devices

Submission Details

510(k) Number K973108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1997
Decision Date March 02, 1998
Days to Decision 195 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 88d · This submission: 195d
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 76
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K973108.
CSF/URINE TOTAL PROTEIN
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TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2
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TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2
K950128 · Emd Chemicals, Inc. · May 1995
DMA MICROPROTEIN PROCEDURE
K942424 · Data Medical Associates, Inc. · Sep 1994
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