Cleared Traditional

K940209 - ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ ...

K940209 is the FDA 510(k) clearance for ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ ... by Ortho Diagnostic Systems, Inc.. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 482-day FDA review.

K940209 · Ortho Diagnostic Systems, Inc. · Hematology device
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May 1995
Decision
482d
Days
Class 2
Risk

K940209 is an FDA 510(k) clearance for the ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on May 11, 1995 after a review of 482 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K940209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1994
Decision Date May 11, 1995
Days to Decision 482 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
369d slower than avg
Panel avg: 113d · This submission: 482d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGN Plasma, Coagulation Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - GGN Plasma, Coagulation Control

All 55
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K940209.
STA - VWF CONTROL [N]+[P] KIT
K962674 · American Bioproducts Co. · Jul 1996
BEHRING COAGULATION TIMER
K955278 · Behring Diagnostics, Inc. · May 1996
PORCINE FACTOR VIII
K952321 · Helena Laboratories · Mar 1996
STA SYSTEM CONTROL [N] + [P] KIT
K943518 · American Bioproducts Co. · Mar 1995
ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II
K944691 · International Technidyne Corp. · Mar 1995
SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)
K941860 · Helena Laboratories · Sep 1994