Cleared Traditional

K861508 - WAKO MICRO TP

K861508 is an FDA 510(k) clearance for WAKO MICRO TP, manufactured by Wako Chemicals USA, Inc.. The device is a Class 2 Chemistry device with product code CEK cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K861508 · Wako Chemicals USA, Inc. · Chemistry device
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Aug 1986
Decision
118d
Days
Class 2
Risk

K861508 is an FDA 510(k) clearance for the WAKO MICRO TP. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Dallas, US). The FDA issued a Cleared decision on August 19, 1986 after a review of 118 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 Wako Chemicals USA, Inc. devices

FDA 510(k) Submission Details - K861508

510(k) Number K861508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1986
Decision Date August 19, 1986
Days to Decision 118 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
30d slower than avg
Panel avg: 88d · This submission: 118d
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 K861508.
DEMAND TOTAL PROTEIN
K863301 · Cooper Biomedical, Inc. · Sep 1986
TOTAL PROTEINS
K863074 · J. D. Assoc. · Sep 1986
EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95
K863005 · Em Diagnostic Systems, Inc. · Aug 1986
VISION TOTAL PROTEIN
K861798 · Abbott Laboratories · Jun 1986
TOTAL PROTEIN PROCEDURE
K861663 · Data Medical Associates, Inc. · Jun 1986
EASY-TEST TOTAL PROTEIN (TP), #67513/93
K860917 · Em Diagnostic Systems, Inc. · Apr 1986