Cleared Traditional

K922565 - NEOPLASTINE(R) CI KIT

K922565 is an FDA 510(k) clearance for NEOPLASTINE CI KIT, manufactured by American Bioproducts Co.. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K922565 · American Bioproducts Co. · Hematology device
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Dec 1992
Decision
189d
Days
Class 2
Risk

K922565 is an FDA 510(k) clearance for the NEOPLASTINE(R) CI KIT. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on December 7, 1992 after a review of 189 days - an extended review cycle.

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 American Bioproducts Co. devices

FDA 510(k) Submission Details - K922565

510(k) Number K922565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1992
Decision Date December 07, 1992
Days to Decision 189 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
76d slower than avg
Panel avg: 113d · This submission: 189d
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 K922565.
THROMBOPLATIN-M WITH CALCIUM
K930212 · Sigma Diagnostics, Inc. · May 1993
ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT
K925604 · Ortho Diagnostic Systems, Inc. · Mar 1993
BIOMERIEUX HEMOLAB THROMBOMAT
K925492 · Biomerieux Vitek, Inc. · Feb 1993
DADE RECOMBOPLASTIN S
K921326 · Baxter Diagnostics, Inc. · Jul 1992
NEOPLASTINE CI PLUS
K922040 · American Bioproducts Co. · Jun 1992
SIMPLASTIN L
K915746 · Organon Teknika Corp. · Feb 1992