Cleared Traditional

K070452 - VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU

K070452 is an FDA 510(k) clearance for VARIANT II HEMOGLOBIN A1C PROGRAM WITH ..., manufactured by Bio-Rad Laboratories, Inc.. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K070452 · Bio-Rad Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
80d
Days
Class 2
Risk

K070452 is an FDA 510(k) clearance for the VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Hercules, US). The FDA issued a Cleared decision on May 7, 2007 after a review of 80 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K070452

510(k) Number K070452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2007
Decision Date May 07, 2007
Days to Decision 80 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 88d · This submission: 80d
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 241
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K070452.
PRIMUS A1CARE ASSAY
K062658 · Primus Corp. · Nov 2007
DCA VANTAGE, MODEL 5075
K071466 · Siemens Medical Solutions Diagnostics · Oct 2007
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,
K070819 · Bio-Rad Laboratories Inc., Clinical Systems Divisi · Jun 2007
ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72
K063306 · Alfa Wassermann, Inc. · Apr 2007
MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON
K070734 · Diazyme Laboratories · Apr 2007
HBA1C
K063209 · Thermo Electron OY · Mar 2007
K070452 · VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
Download PDF FDA Summary Bio-Rad Laboratories,…