Cleared Abbreviated

ACCESS EPO ASSAY (K052223) - FDA 510(k) Clearance

Class II Hematology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K052223 · Beckman Coulter, Inc. · Hematology device
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Oct 2006
Decision
417d
Days
Class 2
Risk

K052223 is an FDA 510(k) clearance for the ACCESS EPO ASSAY. Classified as Assay, Erythropoietin (product code GGT), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on October 6, 2006 after a review of 417 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7250 - the FDA hematology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K052223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2005
Decision Date October 06, 2006
Days to Decision 417 days
Submission Type Abbreviated
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
304d slower than avg
Panel avg: 113d · This submission: 417d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code GGT Assay, Erythropoietin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7250
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.