Cleared Traditional

K922040 - NEOPLASTINE CI PLUS

K922040 is the FDA 510(k) clearance for NEOPLASTINE CI PLUS by American Bioproducts Co.. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K922040 · American Bioproducts Co. · Hematology device
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Jun 1992
Decision
53d
Days
Class 2
Risk

K922040 is an FDA 510(k) clearance for the NEOPLASTINE CI PLUS. 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 June 23, 1992 after a review of 53 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Bioproducts Co. devices

Submission Details

510(k) Number K922040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1992
Decision Date June 23, 1992
Days to Decision 53 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 113d · This submission: 53d
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 K922040.
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
SIMPLASTIN L
K915746 · Organon Teknika Corp. · Feb 1992
ACS ULTRA-1 THROMBOPLASTIN
K913249 · Analytical Control Systems, Inc. · Dec 1991
ACS ULTRA-2 THROMBOPLASTIN
K913250 · Analytical Control Systems, Inc. · Nov 1991