Cleared Traditional

K880677 - TOTAL PROTEIN REAGENT SET

K880677 is an FDA 510(k) clearance for TOTAL PROTEIN REAGENT SET, manufactured by Tech-Neal Scientific, Inc.. The device is a Class 2 Chemistry device with product code CEK cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K880677 · Tech-Neal Scientific, Inc. · Chemistry device
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Mar 1988
Decision
34d
Days
Class 2
Risk

K880677 is an FDA 510(k) clearance for the TOTAL PROTEIN REAGENT SET. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Tech-Neal Scientific, Inc. (Chicago, US). The FDA issued a Cleared decision on March 24, 1988 after a review of 34 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 Tech-Neal Scientific, Inc. devices

FDA 510(k) Submission Details - K880677

510(k) Number K880677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1988
Decision Date March 24, 1988
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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 K880677.
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT)
K881639 · Eastman Kodak Company · Jul 1988
BIOTROL TOTAL PROTEIN H.P.
K882189 · Biotrol, USA, Inc. · Jul 1988
WAKO(TM) AUTOKIT TOTAL PROTEIN
K880312 · Wako Chemicals USA, Inc. · Mar 1988
TOTAL PROTEIN
K875222 · Catachem, Inc. · Jan 1988
EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011
K874476 · Em Diagnostic Systems, Inc. · Nov 1987
TOTAL PROTEIN REAGENT - BIURET METHOD
K870371 · Trace Scientific , Ltd. · Aug 1987