Cleared Traditional

K981200 - IL TEST PLASMINOGEN

K981200 is the FDA 510(k) clearance for IL TEST PLASMINOGEN by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K981200 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
54d
Days
Class 2
Risk

K981200 is an FDA 510(k) clearance for the IL TEST PLASMINOGEN. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on May 26, 1998 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 K981200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1998
Decision Date May 26, 1998
Days to Decision 54 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
59d faster than avg
Panel avg: 113d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GGP Test, Qualitative And Quantitative Factor Deficiency

All 118
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K981200.
IL TEST VON WILLEBRAND FACTOR
K992704 · Instrumentation Laboratory CO · Nov 1999
COAMATIC PLASMIN INHIBITOR
K981817 · Instrumentation Laboratory CO · Sep 1998
IL TEST PLASMIN INHIBITOR
K981696 · Instrumentation Laboratory CO · Aug 1998
COAMATIC PLASMINOGEN
K974711 · Instrumentation Laboratory CO · May 1998
IL TEST PROTEIN C
K980875 · Instrumentation Laboratory CO · Apr 1998
COAMATIC FACTOR VIII
K981038 · Instrumentation Laboratory CO · Apr 1998