Cleared Traditional

K012768 - HEMOSIL RECOMBI PLASTIN

K012768 is the FDA 510(k) clearance for HEMOSIL RECOMBI PLASTIN by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K012768 · Instrumentation Laboratory CO · Hematology device
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Sep 2001
Decision
32d
Days
Class 2
Risk

K012768 is an FDA 510(k) clearance for the HEMOSIL RECOMBI PLASTIN. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on September 18, 2001 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - 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 K012768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2001
Decision Date September 18, 2001
Days to Decision 32 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
81d faster than avg
Panel avg: 113d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
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 - GJS Test, Time, Prothrombin

All 76
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K012768.
PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
K021190 · Roche Diagnostics Corp. · Oct 2002
PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404
K020831 · Roche Diagnostics Corp. · Oct 2002
DADE THROMBOPLASTIN C PLUS
K013155 · Dade Behring, Inc. · Jan 2002
THROMBOREL S
K003870 · Dade Behring, Inc. · Feb 2001
PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM
K992492 · Roche Diagnostics Corp. · Nov 1999
IL TEST PT-FIBRINOGEN RECOMBINANT
K981479 · Instrumentation Laboratory CO · Jul 1998