Cleared Traditional

K924098 - IL MCL-2 COAGULATION ANALYZER

K924098 is the FDA 510(k) clearance for IL MCL-2 COAGULATION ANALYZER by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GKP) cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K924098 · Instrumentation Laboratory CO · Hematology device
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Optimized for regulatory review, auditing and printing
Jun 1993
Decision
309d
Days
Class 2
Risk

K924098 is an FDA 510(k) clearance for the IL MCL-2 COAGULATION ANALYZER. Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on June 18, 1993 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5400 - 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. Elevated predicate reliance profile. 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 K924098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1992
Decision Date June 18, 1993
Days to Decision 309 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
196d slower than avg
Panel avg: 113d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKP Instrument, Coagulation, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5400
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 - GKP Instrument, Coagulation, Automated

All 31
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K924098.
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
K961579 · American Bioproducts Co. · Jul 1996
STA AUTOMATED MULTI-PARAMETRIC ANALYZER
K942117 · American Bioproducts Co. · Feb 1995
CASCADE M, CAT. NO. 1710
K931956 · Helena Laboratories · Aug 1993
CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)
K921465 · Helena Laboratories · Jun 1992
CASCADE 480
K921363 · Helena Laboratories · Jun 1992
CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION
K914946 · Helena Laboratories · Jan 1992