Cleared Traditional

K841736 - IL TEST ANTITHROMBIN III ACTIVITY

K841736 is an FDA 510(k) clearance for IL TEST ANTITHROMBIN III ACTIVITY, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K841736

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.

JBQ Device Classification - Class 2, Special Controls

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 46
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K841736.
DADE ANTITHROMBIN III CHROMOGENIC ASSAY
K880315 · Baxter Healthcare Corp · Mar 1988
IL TEST 97574-15M, ANTITTHROMBIN III ASSASY
K864214 · Instrumentation Laboratory CO · Nov 1986
GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY
K850412 · Warner-Lambert Co. · May 1985
DIACROM * ATIII
K832592 · Wellcome Diagnostics · Sep 1983
IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN
K831961 · Kent Laboratories, Inc. · Aug 1983
PROTOTRO/PROTEOLYTIC ENZYME CONTROL
K831297 · American Dade · Jun 1983