Cleared Traditional

K-ASSAY APO B (K993354) - FDA 510(k) Clearance

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

K993354 · Kamiya Biomedical Co. · Chemistry device
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Oct 1999
Decision
23d
Days
Class 2
Risk

K993354 is an FDA 510(k) clearance for the K-ASSAY APO B. Classified as Alpha-1-lipoprotein, Antigen, Antiserum, Control (product code DER), Class II - Special Controls.

Submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on October 28, 1999 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5580 - 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 Kamiya Biomedical Co. devices

Submission Details

510(k) Number K993354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1999
Decision Date October 28, 1999
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DER Alpha-1-lipoprotein, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5580
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.