Cleared Special

K140801 - VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM

K140801 is an FDA 510(k) clearance for VARIANT II TURBO LINK HEMOGLOBIN A1C PR..., manufactured by Bio-Rad Laboratories, Inc.. The device is a Class 2 Chemistry device with product code LCP cleared through the Special 510(k) pathway after a 86-day FDA review.

K140801 · Bio-Rad Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
86d
Days
Class 2
Risk

K140801 is an FDA 510(k) clearance for the VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM. 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 June 25, 2014 after a review of 86 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K140801

510(k) Number K140801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2014
Decision Date June 25, 2014
Days to Decision 86 days
Submission Type Special
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 faster than avg
Panel avg: 89d · This submission: 86d
Pathway characteristics
Modification to existing cleared device.

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 247
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K140801.
DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT
K133803 · Diazyme Laboratories · Aug 2014
HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM
K141750 · Infopia Co, Ltd. · Jul 2014
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT
K140829 · Beckman Coulter, Inc. · Jul 2014
A1C GEAR SYSTEM
K130014 · Sakae Corporation · Apr 2014
MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS
K133344 · Sebia · Mar 2014
ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
K131307 · Siemens Healthcare Diagnostics, Inc. · Jan 2014
K140801 · VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
Download PDF FDA Summary Bio-Rad Laboratories,…