Cleared Traditional

K031042 - ATAC HEMOGLOBIN A1C REAGENT KIT

K031042 is the FDA 510(k) clearance for ATAC HEMOGLOBIN A1C REAGENT KIT by Clinical Data, Inc.. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K031042 · Clinical Data, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Nov 2003
Decision
216d
Days
Class 2
Risk

K031042 is an FDA 510(k) clearance for the ATAC HEMOGLOBIN A1C REAGENT KIT. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Clinical Data, Inc. (Brea, US). The FDA issued a Cleared decision on November 3, 2003 after a review of 216 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 Clinical Data, Inc. devices

Submission Details

510(k) Number K031042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2003
Decision Date November 03, 2003
Days to Decision 216 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
128d slower than avg
Panel avg: 88d · This submission: 216d
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 111
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K031042.
BIO-RAD D-10 DUAL PROGRAM
K041444 · Bio-Rad Laboratories, Inc. · Jun 2004
VARIANT II HEMOGLOBIN A1C
K040872 · Bio-Rad Laboratories, Inc. · Apr 2004
OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)
K031380 · Olympus America, 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