Cleared Traditional

K955156 - WAKO AUTOKIT CRP NEW (FDA 510(k) Clearance)

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

K955156 · Wako Chemicals USA, Inc. · Immunology device
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Feb 1996
Decision
95d
Days
Class 2
Risk

K955156 is an FDA 510(k) clearance for the WAKO AUTOKIT CRP NEW. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on February 16, 1996 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K955156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1995
Decision Date February 16, 1996
Days to Decision 95 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 104d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCK C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
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 Immunology devices follow this clearance model.