Cleared Traditional

K952608 - MDA SIMPLASTIN LS

K952608 is an FDA 510(k) clearance for MDA SIMPLASTIN LS, manufactured by Organon Teknika Corp.. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K952608 · Organon Teknika Corp. · Hematology device
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Oct 1995
Decision
121d
Days
Class 2
Risk

K952608 is an FDA 510(k) clearance for the MDA SIMPLASTIN LS. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on October 6, 1995 after a review of 121 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K952608

510(k) Number K952608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1995
Decision Date October 06, 1995
Days to Decision 121 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
8d slower than avg
Panel avg: 113d · This submission: 121d
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 102
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K952608.
PROTIME MICROCOAGULATION SYSTEM
K961835 · International Technidyne Corp. · Mar 1997
STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS
K961938 · Nova Biomedical Corp. · Jun 1996
THROMBOPLASTIN-LI REAGENT
K951820 · Helena Laboratories · Oct 1995
COAGUCHEK SYSTEM
K942884 · Boehringer Mannheim Corp. · May 1995
HEMOCHRON HNPT/FACTOR VI PT+
K945078 · International Technidyne Corp. · Apr 1995
ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT
K935748 · Ortho Diagnostic Systems, Inc. · Apr 1995