Cleared Special

K130860 - VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE

K130860 is an FDA 510(k) clearance for VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), manufactured by Bio-Rad Laboratories, Inc., Clinical Systems Divis. The device is a Class 2 Chemistry device with product code LCP cleared through the Special 510(k) pathway after a 28-day FDA review.

K130860 · Bio-Rad Laboratories, Inc., Clinical Systems Divis · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
28d
Days
Class 2
Risk

K130860 is an FDA 510(k) clearance for the VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM.... Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc., Clinical Systems Divis (Hercules, US). The FDA issued a Cleared decision on April 25, 2013 after a review of 28 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., Clinical Systems Divis devices

FDA 510(k) Submission Details - K130860

510(k) Number K130860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2013
Decision Date April 25, 2013
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
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 K130860.
MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS
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K130990 · Bio-Rad Laboratories, Inc., Clinical Systems Divis · May 2013
ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
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CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C
K122101 · Sebia · Dec 2012
VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
K122472 · Bio-Rad Laboratories, Inc., Clinical Systems Divis · Oct 2012