Cleared Traditional

K000361 - K-ASSAY AT-III

K000361 is the FDA 510(k) clearance for K-ASSAY AT-III by Kamiya Biomedical Co.. It is a Class 2 Hematology device (product code JBQ) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K000361 · Kamiya Biomedical Co. · Hematology device
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Apr 2000
Decision
82d
Days
Class 2
Risk

K000361 is an FDA 510(k) clearance for the K-ASSAY AT-III. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on April 26, 2000 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7060 - the FDA hematology 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 K000361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2000
Decision Date April 26, 2000
Days to Decision 82 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 113d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JBQ Antithrombin Iii Quantitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7060
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 Hematology devices follow this clearance model.

Regulatory Peers - JBQ Antithrombin Iii Quantitation

All 37
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K000361.
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
K022550 · Instrumentation Laboratory CO · Aug 2002
COAMATIC AT-400
K022195 · Instrumentation Laboratory CO · Aug 2002
IL TEST LIQUID ANTITHROMBIN
K994238 · Instrumentation Laboratory CO · Jun 2000
IL TEST ANTITHROMBIN
K980499 · Instrumentation Laboratory CO · Apr 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT
K974110 · Beckman Instruments, Inc. · Dec 1997
SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III
K972144 · Sigma Diagnostics, Inc. · Jul 1997