Cleared Traditional

K091486 - K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR

K091486 is an FDA 510(k) clearance for K-ASSAY MICROALBUMIN AND K-ASSAY MICROA..., manufactured by Kamiya Biomedical Co.. The device is a Class 2 Chemistry device with product code DCF cleared through the Traditional 510(k) pathway after a 345-day FDA review.

K091486 · Kamiya Biomedical Co. · Chemistry device
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Apr 2010
Decision
345d
Days
Class 2
Risk

K091486 is an FDA 510(k) clearance for the K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR. Classified as Albumin, Antigen, Antiserum, Control (product code DCF), Class II - Special Controls.

Submitted by Kamiya Biomedical Co. (Tukwila, US). The FDA issued a Cleared decision on April 29, 2010 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5040 - 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. Elevated predicate reliance profile. 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 Kamiya Biomedical Co. devices

FDA 510(k) Submission Details - K091486

510(k) Number K091486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2009
Decision Date April 29, 2010
Days to Decision 345 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
257d slower than avg
Panel avg: 88d · This submission: 345d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCF Device Classification - Class 2, Special Controls

Product Code DCF Albumin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5040
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 - DCF Albumin, Antigen, Antiserum, Control

All 33
Devices cleared under the same product code (DCF) and FDA review panel - the closest regulatory comparables to K091486.
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K082251 · Beckman Coulter, Inc. · Apr 2009
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K061990 · Dade Behring, Inc. · Sep 2006
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K053553 · Polymedco, Inc. · Mar 2006