Cleared Traditional

CLINISTAT TOTAL PROTEIN REAGENT TEST (K896916) - FDA 510(k) Clearance

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

K896916 · Heraeus Kulzer, Inc. · Chemistry device
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Jan 1990
Decision
39d
Days
Class 2
Risk

K896916 is an FDA 510(k) clearance for the CLINISTAT TOTAL PROTEIN REAGENT TEST. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Elkhart, US). The FDA issued a Cleared decision on January 19, 1990 after a review of 39 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K896916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1989
Decision Date January 19, 1990
Days to Decision 39 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
49d faster than avg
Panel avg: 88d · This submission: 39d
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 29
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K896916.
ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13
K912810 · Em Diagnostic Systems, Inc. · Jul 1991
SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420
K905661 · Em Diagnostic Systems, Inc. · Jan 1991
COBAS READY TOTAL PROTEIN REAGENT
K896230 · Roche Diagnostic Systems, Inc. · Feb 1990
EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420
K893915 · Em Diagnostic Systems, Inc. · Aug 1989
TOTAL PROTEIN REAGENT
K890278 · Sigma Chemical Co. · Mar 1989
TOTAL PROTEIN TEST (TP) ITEM #65670
K884703 · Em Diagnostic Systems, Inc. · Jan 1989