Cleared Traditional

K841736 - IL TEST ANTITHROMBIN III ACTIVITY

K841736 is the FDA 510(k) clearance for IL TEST ANTITHROMBIN III ACTIVITY by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code JBQ) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K841736 · Instrumentation Laboratory CO · Hematology device
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Sep 1984
Decision
132d
Days
Class 2
Risk

K841736 is an FDA 510(k) clearance for the IL TEST ANTITHROMBIN III ACTIVITY. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on September 6, 1984 after a review of 132 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K841736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1984
Decision Date September 06, 1984
Days to Decision 132 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
19d slower than avg
Panel avg: 113d · This submission: 132d
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 K841736.
ENZYGNOST(R) TAT REAGENTS
K880700 · Behring Diagnostics, Inc. · Apr 1988
DADE ANTITHROMBIN III CHROMOGENIC ASSAY
K880315 · Baxter Healthcare Corp · Mar 1988
IL TEST 97574-15M, ANTITTHROMBIN III ASSASY
K864214 · Instrumentation Laboratory CO · Nov 1986
PROTOTRO/PROTEOLYTIC ENZYME CONTROL
K831297 · American Dade · Jun 1983
ACA ANTITHROMBIN III PLASMINOGEN CALIB
K812626 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1981
ACA ANTITHROMBIN III TEST PACK
K812627 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1981