Cleared Traditional

K070819 - VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,

K070819 is an FDA 510(k) clearance for VARIANT II TURBO LINK HEMOGLOBIN A1C PR..., manufactured by Bio-Rad Laboratories Inc., Clinical Systems Divisi. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K070819 · Bio-Rad Laboratories Inc., Clinical Systems Divisi · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
91d
Days
Class 2
Risk

K070819 is an FDA 510(k) clearance for the VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOG.... Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Bio-Rad Laboratories Inc., Clinical Systems Divisi (Hercules, US). The FDA issued a Cleared decision on June 25, 2007 after a review of 91 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K070819

510(k) Number K070819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2007
Decision Date June 25, 2007
Days to Decision 91 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
3d slower than avg
Panel avg: 88d · This submission: 91d
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 K070819.
AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
K072686 · Axis-Shield Diagnostics, Ltd. · Mar 2008
PRIMUS A1CARE ASSAY
K062658 · Primus Corp. · Nov 2007
DCA VANTAGE, MODEL 5075
K071466 · Siemens Medical Solutions Diagnostics · Oct 2007
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
K070452 · Bio-Rad Laboratories, Inc. · May 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
K070819 · VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,
Download PDF FDA Summary Bio-Rad Laboratories …