Cleared Traditional

K073309 - ABX PENTRA HBA1C WB

K073309 is the FDA 510(k) clearance for ABX PENTRA HBA1C WB by Horiba Abx. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K073309 · Horiba Abx · Chemistry device
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Oct 2008
Decision
329d
Days
Class 2
Risk

K073309 is an FDA 510(k) clearance for the ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Horiba Abx (Montpellier, FR). The FDA issued a Cleared decision on October 17, 2008 after a review of 329 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Horiba Abx devices

Submission Details

510(k) Number K073309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2007
Decision Date October 17, 2008
Days to Decision 329 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
241d slower than avg
Panel avg: 88d · This submission: 329d
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 K073309.
DIMENSIONS HB1C KIT, MODEL DF105A
K102510 · Siemens Healthcare Diagnostics · May 2011
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730
K090699 · Bio-Rad Laboratories, Inc. · Jul 2009
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
K090413 · Bayer Healthcare, LLC · May 2009
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
K072714 · Roche Diagnostics Corp. · Apr 2008
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
K070452 · Bio-Rad Laboratories, Inc. · May 2007
MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON
K070734 · Diazyme Laboratories · Apr 2007