Cleared Traditional

K003870 - THROMBOREL S

K003870 is an FDA 510(k) clearance for THROMBOREL S, 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 67-day FDA review.

K003870 · Dade Behring, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
67d
Days
Class 2
Risk

K003870 is an FDA 510(k) clearance for the THROMBOREL S. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on February 20, 2001 after a review of 67 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 Dade Behring, Inc. devices

FDA 510(k) Submission Details - K003870

510(k) Number K003870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2000
Decision Date February 20, 2001
Days to Decision 67 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
46d faster than avg
Panel avg: 113d · This submission: 67d
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 K003870.
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
PACIFIC HEMOSTASIS THROMBOPLASTIN D
K994100 · Pacific Hemostasis · Feb 2000
AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)
K994006 · Avocet Medical, Inc. · Feb 2000
AVOCET ACUSURE SYSTEM
K991286 · Avocet Medical, Inc. · Nov 1999