Cleared Traditional

K843535 - ORTHO BRAIN THROMBOPLASTIN DILUENT

K843535 is the FDA 510(k) clearance for ORTHO BRAIN THROMBOPLASTIN DILUENT by Ortho Diagnostic Systems, Inc.. It is a Class 2 Hematology device (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

Submission Details

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.

Device Classification

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 94
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
LIQUID THROMBOPLASTIN REAGENT
K830331 · Helena Laboratories · Apr 1983
SIGMA PROCEDURE #890
K811784 · Sigma Chemical Co. · Jul 1981
LANCER COAGENT PT KIT
K792031 · Sherwood Medical Co. · Nov 1979