Cleared Traditional

K182651 - HbA1c Advanced (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182651 · Beckman Coulter Ireland, Inc. · Chemistry device
Jan 2019
Decision
114d
Days
Class 2
Risk

K182651 is an FDA 510(k) clearance for the HbA1c Advanced. Classified as Hemoglobin A1c Test System (product code PDJ), Class II - Special Controls.

Submitted by Beckman Coulter Ireland, Inc. (O'Callaghan'S Mills, IE). The FDA issued a Cleared decision on January 16, 2019 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1373 - the FDA in vitro diagnostics and chemistry 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K182651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2018
Decision Date January 16, 2019
Days to Decision 114 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 234d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDJ Hemoglobin A1c Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1373
Definition Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes.
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 Chemistry devices follow this clearance model.

Regulatory Peers - PDJ Hemoglobin A1c Test System

Devices cleared under the same product code (PDJ) and FDA review panel - the closest regulatory comparables to K182651.
Medconn 8K Glycated Hemoglobin Test System
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