Cleared Traditional

K781104 - PLASMA COAGULATION CONT.

K781104 is the FDA 510(k) clearance for PLASMA COAGULATION CONT. by Ortho Diagnostics, Inc.. It is a Class 2 Hematology device (product code GFO) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K781104 · Ortho Diagnostics, Inc. · Hematology device
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Aug 1978
Decision
38d
Days
Class 2
Risk

K781104 is an FDA 510(k) clearance for the PLASMA COAGULATION CONT., ABNORMAL. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Ortho Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1978 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ortho Diagnostics, Inc. devices

Submission Details

510(k) Number K781104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1978
Decision Date August 10, 1978
Days to Decision 38 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 113d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GFO Activated Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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 - GFO Activated Partial Thromboplastin

All 38
Devices cleared under the same product code (GFO) and FDA review panel - the closest regulatory comparables to K781104.
KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT
K884485 · King Diagnostics, Inc. · Dec 1988
UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
K882325 · Sclavo, Inc. · Aug 1988
ALUMINA SILICA-ACTIVATED PARTIAL THROM
K820835 · Hyland Therapeutic Div., Travenol Laboratories · Apr 1982
HEPARIN CONTROL PLASMA
K760918 · Hyland Therapeutic Div., Travenol Laboratories · Jan 1977
ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT
K760318 · Dade, Baxter Travenol Diagnostics, Inc. · Aug 1976