Cleared Traditional

K843535 - ORTHO BRAIN THROMBOPLASTIN DILUENT

K843535 is an FDA 510(k) clearance for ORTHO BRAIN THROMBOPLASTIN DILUENT, manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K843535 · Ortho Diagnostic Systems, Inc. · Hematology device
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Dec 1984
Decision
96d
Days
Class 2
Risk

K843535 is an FDA 510(k) clearance for the ORTHO BRAIN THROMBOPLASTIN DILUENT. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on December 12, 1984 after a review of 96 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 Ortho Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K843535

510(k) Number K843535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1984
Decision Date December 12, 1984
Days to Decision 96 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 113d · This submission: 96d
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 113
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K843535.
THROMBOPLASTIN.R
K864274 · American Dade · Nov 1986
PLASTINEX
K852484 · Bio/Data Corp. · Aug 1985
ACA PROTHROMBIN TIME ANALYTICAL TEST PACK
K851125 · E.I. Dupont DE Nemours & Co., Inc. · May 1985
DIA THROMBIN DIA PLASTIN
K840802 · Diatech, Inc. · May 1984
EASYTOUCH TROMBOPLASTIN REAGENT
K832427 · Worthington Diagnostic Systems · Oct 1983
LIQUID THROMBOPLASTIN REAGENT
K830331 · Helena Laboratories · Apr 1983