Cleared Traditional

K993496 - RETIC-QUINOX

K993496 is the FDA 510(k) clearance for RETIC-QUINOX by Hematronix, Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K993496 · Hematronix, Inc. · Hematology device
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Nov 1999
Decision
46d
Days
Class 2
Risk

K993496 is an FDA 510(k) clearance for the RETIC-QUINOX. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Hematronix, Inc. (Benicia, US). The FDA issued a Cleared decision on November 30, 1999 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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 Hematronix, Inc. devices

Submission Details

510(k) Number K993496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1999
Decision Date November 30, 1999
Days to Decision 46 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 113d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 - JPK Mixture, Hematology Quality Control

All 134
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K993496.
PENTRA 5D
K003534 · R&D Systems, Inc. · Dec 2000
R & D 3K RETIC
K003208 · R&D Systems, Inc. · Nov 2000
RETIC CHEX LINEARITY
K000115 · Streck Laboratories, Inc. · Mar 2000
SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE
K991876 · R&D Systems, Inc. · Jun 1999
IMMUNO-TROL CONTROL CELLS
K984216 · Coulter Corp. · Mar 1999
CBC-5D HEMATOLOGY CONTROL
K983032 · R&D Systems, Inc. · Feb 1999