Cleared Traditional

K993213 - K-ASSAY IGA

K993213 is the FDA 510(k) clearance for K-ASSAY IGA by Kamiya Biomedical Co.. It is a Class 2 Immunology device (product code CFF) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K993213 · Kamiya Biomedical Co. · Immunology device
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Nov 1999
Decision
60d
Days
Class 2
Risk

K993213 is an FDA 510(k) clearance for the K-ASSAY IGA. Classified as Immunoelectrophoretic, Immunoglobulins, (g, A, M) (product code CFF), Class II - Special Controls.

Submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on November 23, 1999 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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

Submission Details

510(k) Number K993213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1999
Decision Date November 23, 1999
Days to Decision 60 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
44d faster than avg
Panel avg: 104d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFF Immunoelectrophoretic, Immunoglobulins, (g, A, M)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - CFF Immunoelectrophoretic, Immunoglobulins, (g, A, M)

All 16
Devices cleared under the same product code (CFF) and FDA review panel - the closest regulatory comparables to K993213.
SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389
K024162 · Helena Laboratories · Feb 2003
PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100
K002799 · Beckman Coulter, Inc. · Oct 2000
K-ASSAY IGM
K993323 · Kamiya Biomedical Co. · Nov 1999
POLYSLIT IFE KIT
K990998 · Helena Laboratories · Jun 1999
SPIFE IFE-6
K973040 · Helena Laboratories · Jan 1998
IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC
K924767 · The Binding Site, Ltd. · Feb 1993