Cleared Traditional

K920767 - NYCOPLASTIN

K920767 is an FDA 510(k) clearance for NYCOPLASTIN, manufactured by Nycomed Pharma AS. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 359-day FDA review.

K920767 · Nycomed Pharma AS · Hematology device
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Feb 1993
Decision
359d
Days
Class 2
Risk

K920767 is an FDA 510(k) clearance for the NYCOPLASTIN. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Nycomed Pharma AS (N-40401 Oslo 4, Norway, NO). The FDA issued a Cleared decision on February 12, 1993 after a review of 359 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Nycomed Pharma AS devices

FDA 510(k) Submission Details - K920767

510(k) Number K920767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1992
Decision Date February 12, 1993
Days to Decision 359 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
246d slower than avg
Panel avg: 113d · This submission: 359d
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 115
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K920767.
IL TEST (TM) PT-FIBRINOGEN HS PLUS
K933252 · Instrumentation Laboratory CO · Oct 1993
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
NEOPLASTINE(R) CI KIT
K922565 · American Bioproducts Co. · Dec 1992
DADE RECOMBOPLASTIN S
K921326 · Baxter Diagnostics, Inc. · Jul 1992