Cleared Traditional

K893915 - EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420

K893915 is an FDA 510(k) clearance for EMDS TOTAL PROTEIN (TP), manufactured by Em Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code CEK cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K893915 · Em Diagnostic Systems, Inc. · Chemistry device
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Aug 1989
Decision
93d
Days
Class 2
Risk

K893915 is an FDA 510(k) clearance for the EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420. 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 August 31, 1989 after a review of 93 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 Em Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K893915

510(k) Number K893915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1989
Decision Date August 31, 1989
Days to Decision 93 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
5d slower than avg
Panel avg: 88d · This submission: 93d
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 100
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K893915.
COULTER TOTAL PROTEIN REAGENT
K897166 · Coulter Electronics, Inc. · Feb 1990
COBAS READY TOTAL PROTEIN REAGENT
K896230 · Roche Diagnostic Systems, Inc. · Feb 1990
CLINISTAT TOTAL PROTEIN REAGENT TEST
K896916 · Heraeus Kulzer, Inc. · Jan 1990
DMA MICROPROTEIN PROCEDURE
K890868 · Data Medical Associates, Inc. · Mar 1989
TOTAL PROTEIN REAGENT
K890278 · Sigma Chemical Co. · Mar 1989
TOTAL PROTEIN REAGENT
K890317 · Medical Analysis Systems, Inc. · Mar 1989