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
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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.

View all Bio-Rad Laboratories, Inc. devices

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
2d faster than avg
Panel avg: 88d · 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 202
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K140801.
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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