Cleared Traditional

K993481 - K-ASSAY C4

K993481 is an FDA 510(k) clearance for K-ASSAY C4, manufactured by Kamiya Biomedical Co.. The device is a Class 2 Immunology device with product code DBI cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K993481 · Kamiya Biomedical Co. · Immunology device
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Nov 1999
Decision
46d
Days
Class 2
Risk

K993481 is an FDA 510(k) clearance for the K-ASSAY C4. Classified as Complement C4, Antigen, Antiserum, Control (product code DBI), Class II - Special Controls.

Submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on November 29, 1999 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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: 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

FDA 510(k) Submission Details - K993481

510(k) Number K993481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1999
Decision Date November 29, 1999
Days to Decision 46 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 105d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBI Device Classification - Class 2, Special Controls

Product Code DBI Complement C4, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - DBI Complement C4, Antigen, Antiserum, Control

All 27
Devices cleared under the same product code (DBI) and FDA review panel - the closest regulatory comparables to K993481.
RANDOX COMPLEMENT C4
K000468 · Randox Laboratories, Ltd. · Mar 2000
DIMENSION C4 FLEX REAGENT CARTRIDGE
K994293 · Dade Behring, Inc. · Mar 2000
C4 MININEPH ANTISERUM
K981785 · The Binding Site, Ltd. · Dec 1999
C4
K983356 · Abbott Laboratories · Nov 1998
N-ASSAY TIA C4 TEST KIT
K964297 · Crestat Diagnostics, Inc. · Jul 1997
N-ASSAY TIA MULTI V-NL
K964300 · Crestat Diagnostics, Inc. · Jul 1997