Cleared Traditional

K242170 - K-ASSAY CRP (Ver.2)

K242170 is an FDA 510(k) clearance for K-ASSAY CRP (Ver.2), manufactured by Kamiya Biomedical Company, LLC. The device is a Class 2 Immunology device with product code DCK cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K242170 · Kamiya Biomedical Company, LLC · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
268d
Days
Class 2
Risk

K242170 is an FDA 510(k) clearance for the K-ASSAY CRP (Ver.2). Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Kamiya Biomedical Company, LLC (Tukwila, US). The FDA issued a Cleared decision on April 18, 2025 after a review of 268 days - an extended review cycle.

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 Kamiya Biomedical Company, LLC devices

FDA 510(k) Submission Details - K242170

510(k) Number K242170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2024
Decision Date April 18, 2025
Days to Decision 268 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 104d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCK Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 89
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K242170.
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VITROS Chemistry Products CRP Slides
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