Cleared Traditional

K050574 - AFINION HBALC

K050574 is the FDA 510(k) clearance for AFINION HBALC by Axis-Shield Poc AS. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K050574 · Axis-Shield Poc AS · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
137d
Days
Class 2
Risk

K050574 is an FDA 510(k) clearance for the AFINION HBALC. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Axis-Shield Poc AS (San Diego, US). The FDA issued a Cleared decision on July 22, 2005 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - 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.

View all Axis-Shield Poc AS devices

Submission Details

510(k) Number K050574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2005
Decision Date July 22, 2005
Days to Decision 137 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 88d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCP Assay, Glycosylated Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
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 - LCP Assay, Glycosylated Hemoglobin

All 137
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K050574.
D-10 HEMOGLOBIN A1C PROGRAM
K060001 · Bio-Rad Laboratories, Inc. · Jan 2006
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
K052464 · Roche Diagnostics Corp. · Sep 2005
HEMOGLOBIN A1C REAGENT SET
K051200 · Teco Diagnostics · Aug 2005
SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
K042459 · Beckman Coulter, Inc. · Nov 2004
DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT
K042193 · Diazyme Laboratories · Oct 2004
THE VITROS 5,1 FS CHEMISTRY SYSTEM
K041764 · Ortho-Clinical Diagnostics · Sep 2004