Cleared Traditional

K935174 - TOTAL PROTEIN TEST (TPRO)

K935174 is the FDA 510(k) clearance for TOTAL PROTEIN TEST (TPRO) by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CEK) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K935174 · Em Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
50d
Days
Class 2
Risk

K935174 is an FDA 510(k) clearance for the TOTAL PROTEIN TEST (TPRO). Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on December 16, 1993 after a review of 50 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K935174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1993
Decision Date December 16, 1993
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
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 K935174.
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
MICROPROTEIN REAGENT SET
K921412 · Sterling Diagnostics, Inc. · Jan 1993
OLYUMPUS TOTAL PROTEIN REAGENT
K924659 · Olympus Corp. · Dec 1992
SYNCHRON TOTAL PROTEIN TEST --MODIFIED
K922467 · Beckman Instruments, Inc. · Nov 1992