Cleared Traditional

K925604 - ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT

K925604 is an FDA 510(k) clearance for ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT, manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K925604 · Ortho Diagnostic Systems, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K925604

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.

GJS Device Classification - Class 2, Special Controls

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 113
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