Cleared Traditional

K851641 - THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL

K851641 is an FDA 510(k) clearance for THROMBOSIL SILICA ACTIVATED PTT REAGENT..., manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 1 Hematology device with product code MSJ cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K851641 · Ortho Diagnostic Systems, Inc. · Hematology device
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Jul 1985
Decision
95d
Days
Class 1
Risk

K851641 is an FDA 510(k) clearance for the THROMBOSIL SILICA ACTIVATED PTT REAGENT THROMBOXIL. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on July 23, 1985 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1475 - 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 - K851641

510(k) Number K851641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1985
Decision Date July 23, 1985
Days to Decision 95 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
18d faster than avg
Panel avg: 113d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

MSJ Device Classification - Class 1, General Controls

Product Code MSJ Apolipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.