Cleared Traditional

K925604 - ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT

K925604 is the FDA 510(k) clearance for ORTHO(TM) RECOMBIPLASTIN W/ORTHO 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 127-day FDA review.

K925604 · Ortho Diagnostic Systems, Inc. · Hematology device
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Mar 1993
Decision
127d
Days
Class 2
Risk

K925604 is an FDA 510(k) clearance for the ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on March 12, 1993 after a review of 127 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 K925604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1992
Decision Date March 12, 1993
Days to Decision 127 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
14d slower than avg
Panel avg: 113d · This submission: 127d
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 K925604.
ASSESS(TM) HIGH ABNORMAL CONTROL
K931118 · Instrumentation Laboratory CO · Mar 1994
IL TEST (TM) PT-FIBRINOGEN HS PLUS
K933252 · Instrumentation Laboratory CO · Oct 1993
THROMBOPLATIN-M WITH CALCIUM
K930212 · Sigma Diagnostics, Inc. · May 1993
BIOMERIEUX HEMOLAB THROMBOMAT
K925492 · Biomerieux Vitek, Inc. · Feb 1993
NEOPLASTINE(R) CI KIT
K922565 · American Bioproducts Co. · Dec 1992
DADE RECOMBOPLASTIN S
K921326 · Baxter Diagnostics, Inc. · Jul 1992