Cleared Traditional

K843107 - SYSTEMATE TOTAL PROTEIN 67218

K843107 is the FDA 510(k) clearance for SYSTEMATE TOTAL PROTEIN 67218 by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CEK) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K843107 · Em Diagnostic Systems, Inc. · Chemistry device
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Aug 1984
Decision
20d
Days
Class 2
Risk

K843107 is an FDA 510(k) clearance for the SYSTEMATE TOTAL PROTEIN 67218. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Walker, US). The FDA issued a Cleared decision on August 27, 1984 after a review of 20 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 K843107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1984
Decision Date August 27, 1984
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 88d · This submission: 20d
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 77
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K843107.
AMRESCO FLOW PAC TOTAL PROTEIN BIURET & BLANK CONC
K852844 · American Research Products Co. · Jul 1985
TOTAL PROTEIN LIQUID STABLE REAGENT SET
K851877 · Medical Analysis Systems, Inc. · May 1985
TOTAL PROTEIN ASSAY KIT
K843028 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984
TOTAL PROTEIN REAGENT BIURET
K841466 · Reagents Applications, Inc. · May 1984
SERUM TOTAL PROTEIN REAGENT SET
K841069 · Medical Specialties, Inc. · May 1984
PARAMAX TOTAL PROTEIN REAGENT TP
K845052 · American Dade · Apr 1984