Cleared Traditional

K961835 - PROTIME MICROCOAGULATION SYSTEM

K961835 is an FDA 510(k) clearance for PROTIME MICROCOAGULATION SYSTEM, manufactured by International Technidyne Corp.. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K961835 · International Technidyne Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
303d
Days
Class 2
Risk

K961835 is an FDA 510(k) clearance for the PROTIME MICROCOAGULATION SYSTEM. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on March 12, 1997 after a review of 303 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 International Technidyne Corp. devices

FDA 510(k) Submission Details - K961835

510(k) Number K961835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1996
Decision Date March 12, 1997
Days to Decision 303 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
190d slower than avg
Panel avg: 113d · This submission: 303d
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 107
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K961835.
MDA SIMPLASTIN HTF
K974566 · Organon Teknika Corp. · Feb 1998
SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM
K972796 · Sigma Diagnostics, Inc. · Oct 1997
COAGUCHEK PST SYSTEM
K962571 · Boehringer Mannheim Corp. · Apr 1997
STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS
K961938 · Nova Biomedical Corp. · Jun 1996
THROMBOPLASTIN-LI REAGENT
K951820 · Helena Laboratories · Oct 1995
MDA SIMPLASTIN LS
K952608 · Organon Teknika Corp. · Oct 1995