Cleared Traditional

K013155 - DADE THROMBOPLASTIN C PLUS

K013155 is an FDA 510(k) clearance for DADE THROMBOPLASTIN C PLUS, manufactured by Dade Behring, Inc.. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K013155 · Dade Behring, Inc. · Hematology device
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Jan 2002
Decision
119d
Days
Class 2
Risk

K013155 is an FDA 510(k) clearance for the DADE THROMBOPLASTIN C PLUS. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Miami, US). The FDA issued a Cleared decision on January 18, 2002 after a review of 119 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Dade Behring, Inc. devices

FDA 510(k) Submission Details - K013155

510(k) Number K013155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2001
Decision Date January 18, 2002
Days to Decision 119 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
6d slower than avg
Panel avg: 113d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GJS Device Classification - Class 2, Special Controls

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 112
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K013155.
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
HARMONY INR MONITORING SYSTEM
K022922 · Lifescan, Inc. · Sep 2002
HEMOSIL RECOMBI PLASTIN
K012768 · Instrumentation Laboratory CO · Sep 2001
PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
K010599 · International Technidyne Corp. · Jul 2001
RUBICON PROTHROMBIN TIME MONITORING SYSTEM
K001699 · Lifescan, Inc. · May 2001