Cleared Traditional

K922565 - NEOPLASTINE CI KIT

K922565 is the FDA 510(k) clearance for NEOPLASTINE CI KIT by American Bioproducts Co.. It is a Class 2 Hematology device (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

Submission Details

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.

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 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