Cleared Traditional

K001699 - RUBICON PROTHROMBIN TIME MONITORING SYSTEM

K001699 is an FDA 510(k) clearance for RUBICON PROTHROMBIN TIME MONITORING SYSTEM, manufactured by Lifescan, Inc.. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 347-day FDA review.

K001699 · Lifescan, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
347d
Days
Class 2
Risk

K001699 is an FDA 510(k) clearance for the RUBICON PROTHROMBIN TIME MONITORING SYSTEM. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Lifescan, Inc. (Milpitas, US). The FDA issued a Cleared decision on May 15, 2001 after a review of 347 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Lifescan, Inc. devices

FDA 510(k) Submission Details - K001699

510(k) Number K001699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2000
Decision Date May 15, 2001
Days to Decision 347 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
234d slower than avg
Panel avg: 113d · This submission: 347d
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 111
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K001699.
DADE THROMBOPLASTIN C PLUS
K013155 · Dade Behring, Inc. · Jan 2002
HEMOSIL RECOMBI PLASTIN
K012768 · Instrumentation Laboratory CO · Sep 2001
PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
K010599 · International Technidyne Corp. · Jul 2001
THROMBOREL S
K003870 · Dade Behring, Inc. · Feb 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