Cleared Traditional

K031296 - LIQUI-HEME GLYCO A1C ASSAY

K031296 is the FDA 510(k) clearance for LIQUI-HEME GLYCO A1C ASSAY by Biodiagnostic Intl. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 541-day FDA review.

K031296 · Biodiagnostic Intl · Chemistry device
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Oct 2004
Decision
541d
Days
Class 2
Risk

K031296 is an FDA 510(k) clearance for the LIQUI-HEME GLYCO A1C ASSAY. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Biodiagnostic Intl (Brea, US). The FDA issued a Cleared decision on October 15, 2004 after a review of 541 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Biodiagnostic Intl devices

Submission Details

510(k) Number K031296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2003
Decision Date October 15, 2004
Days to Decision 541 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
453d slower than avg
Panel avg: 88d · This submission: 541d
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 138
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K031296.
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
BIO-RAD D-10 DUAL PROGRAM
K041444 · Bio-Rad Laboratories, Inc. · Jun 2004
VARIANT II HEMOGLOBIN A1C
K040872 · Bio-Rad Laboratories, Inc. · Apr 2004