Cleared Traditional

K864214 - IL TEST 97574-15M

K864214 is the FDA 510(k) clearance for IL TEST 97574-15M by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code JBQ) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K864214 · Instrumentation Laboratory CO · Hematology device
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Nov 1986
Decision
28d
Days
Class 2
Risk

K864214 is an FDA 510(k) clearance for the IL TEST 97574-15M, ANTITTHROMBIN III ASSASY. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on November 25, 1986 after a review of 28 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K864214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1986
Decision Date November 25, 1986
Days to Decision 28 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 113d · This submission: 28d
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 31
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K864214.
BERICHROM(R) ANTITHROMBIN III
K883662 · Behring Diagnostics, Inc. · Nov 1988
ENZYGNOST(R) TAT REAGENTS
K880700 · Behring Diagnostics, Inc. · Apr 1988
DADE ANTITHROMBIN III CHROMOGENIC ASSAY
K880315 · Baxter Healthcare Corp · Mar 1988
IL TEST ANTITHROMBIN III ACTIVITY
K841736 · Instrumentation Laboratory CO · Sep 1984
PROTOTRO/PROTEOLYTIC ENZYME CONTROL
K831297 · American Dade · Jun 1983
ACA ANTITHROMBIN III PLASMINOGEN CALIB
K812626 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1981