Cleared Traditional

K980242 - IL TEST HEPARIN

K980242 is the FDA 510(k) clearance for IL TEST HEPARIN by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code KFF) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K980242 · Instrumentation Laboratory CO · Hematology device
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Optimized for regulatory review, auditing and printing
Mar 1998
Decision
55d
Days
Class 2
Risk

K980242 is an FDA 510(k) clearance for the IL TEST HEPARIN. Classified as Assay, Heparin (product code KFF), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on March 19, 1998 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7525 - 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 K980242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1998
Decision Date March 19, 1998
Days to Decision 55 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
58d faster than avg
Panel avg: 113d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KFF Assay, Heparin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7525
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 - KFF Assay, Heparin

All 23
Devices cleared under the same product code (KFF) and FDA review panel - the closest regulatory comparables to K980242.
HemosIL Liquid Anti-Xa
K213464 · Instrumentation Laboratory CO · Oct 2022
HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
K090209 · Instrumentation Laboratory CO · Jun 2009
COAMATIC HEPARIN
K983178 · Instrumentation Laboratory CO · Nov 1998
SPECTROLYSE HEPARIN (ANTI-IIA)
K972209 · Medical Diagnostic Technologies, Inc. · Aug 1997
MDA HEPARIN ANTI-X ASSAY
K965076 · Organon Teknika Corp. · Mar 1997
CHROM Z-HEPARIN, CAT. NO 5242
K952667 · Helena Laboratories · Feb 1996