Cleared Traditional

K030553 - ARKIT HBA1C

K030553 is an FDA 510(k) clearance for ARKIT HBA1C, manufactured by Arkray, Inc.. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K030553 · Arkray, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
193d
Days
Class 2
Risk

K030553 is an FDA 510(k) clearance for the ARKIT HBA1C. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Arkray, Inc. (Wilmington, US). The FDA issued a Cleared decision on September 2, 2003 after a review of 193 days - an extended review cycle.

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 Arkray, Inc. devices

FDA 510(k) Submission Details - K030553

510(k) Number K030553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2003
Decision Date September 02, 2003
Days to Decision 193 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
105d slower than avg
Panel avg: 88d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCP Device Classification - Class 2, Special Controls

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 150
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K030553.
MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS
K033674 · Seradyn, Inc. · Feb 2004
OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)
K031380 · Olympus America, Inc. · Nov 2003
ATAC HEMOGLOBIN A1C REAGENT KIT
K031042 · Clinical Data, Inc. · Nov 2003
D-10 HEMOGLOBIN A1C
K031043 · Bio-Rad Laboratories, Inc. · Aug 2003
HEMOGLOBIN A1C REAGENT SET
K031539 · Pointe Scientific, Inc., · Aug 2003
RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
K023763 · Randox Laboratories, Ltd. · Jan 2003