Cleared Traditional

K862301 - IL SYSTEM 810, ACL AND THE REAGENT SETS

K862301 is an FDA 510(k) clearance for IL SYSTEM 810, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code GJA cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K862301 · Instrumentation Laboratory CO · Hematology device
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Sep 1986
Decision
78d
Days
Class 2
Risk

K862301 is an FDA 510(k) clearance for the IL SYSTEM 810, ACL AND THE REAGENT SETS. Classified as Test, Thrombin Time (product code GJA), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on September 3, 1986 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7875 - 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

FDA 510(k) Submission Details - K862301

510(k) Number K862301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1986
Decision Date September 03, 1986
Days to Decision 78 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
35d faster than avg
Panel avg: 113d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GJA Device Classification - Class 2, Special Controls

Product Code GJA Test, Thrombin Time
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7875
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 - GJA Test, Thrombin Time

All 17
Devices cleared under the same product code (GJA) and FDA review panel - the closest regulatory comparables to K862301.
THROMBIN TIME REAGENT
K894467 · Sigma Chemical Co. · Sep 1989
THROMBIN-PREST REAGENT KIT
K884384 · American Bioproducts Co. · Dec 1988
FIBRI-PREST/THROMBIN-PREST CONTROLS
K884385 · American Bioproducts Co. · Dec 1988
THROMBINEX BOVINE THROMBIN
K845000 · Bio/Data Corp. · Mar 1985
THROMBOLYTIC ACTIVITY TEST
K834301 · Bio/Data Corp. · Feb 1984
THROMBIN TIME TEST
K822466 · American Dade · Sep 1982