Cleared Traditional

K913259 - NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA A...

K913259 is the FDA 510(k) clearance for NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA A... by Nova Biomedical Corp.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K913259 · Nova Biomedical Corp. · Hematology device
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Oct 1991
Decision
77d
Days
Class 2
Risk

K913259 is an FDA 510(k) clearance for the NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on October 8, 1991 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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 Nova Biomedical Corp. devices

Submission Details

510(k) Number K913259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1991
Decision Date October 08, 1991
Days to Decision 77 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
36d faster than avg
Panel avg: 113d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 - GKZ Counter, Differential Cell

All 190
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K913259.
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K910834 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1991