Cleared Traditional

K050721 - ABX ERYTROL

K050721 is the FDA 510(k) clearance for ABX ERYTROL by Horiba Abx. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K050721 · Horiba Abx · Hematology device
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Jun 2005
Decision
72d
Days
Class 2
Risk

K050721 is an FDA 510(k) clearance for the ABX ERYTROL. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Horiba Abx (Montpellier, FR). The FDA issued a Cleared decision on June 1, 2005 after a review of 72 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 Horiba Abx devices

Submission Details

510(k) Number K050721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2005
Decision Date June 01, 2005
Days to Decision 72 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
41d faster than avg
Panel avg: 113d · This submission: 72d
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 K050721.
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R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL
K051339 · R&D Systems, Inc. · Jul 2005
LIQUICHEK RETICULOCYTE CONTROL (A)
K042836 · Bio-Rad · Nov 2004
RETIC-CHEX FOR CELL-DYN
K042587 · Streck Laboratories, Inc. · Oct 2004
METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
K042336 · Bio-Rad Laboratories, Inc. · Oct 2004