Cleared Traditional

K994238 - IL TEST LIQUID ANTITHROMBIN

K994238 is the FDA 510(k) clearance for IL TEST LIQUID ANTITHROMBIN by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code JBQ) cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K994238 · Instrumentation Laboratory CO · Hematology device
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Jun 2000
Decision
190d
Days
Class 2
Risk

K994238 is an FDA 510(k) clearance for the IL TEST LIQUID ANTITHROMBIN. 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 June 23, 2000 after a review of 190 days - an extended review 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: 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 K994238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1999
Decision Date June 23, 2000
Days to Decision 190 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 113d · This submission: 190d
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 K994238.
HEMOSIL LIQUID ANTITHROMBIN XL
K033775 · Instrumentation Laboratory CO · Jan 2004
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
K022550 · Instrumentation Laboratory CO · Aug 2002
COAMATIC AT-400
K022195 · Instrumentation Laboratory CO · Aug 2002
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