Cleared Special

K130990 - VARIANT(TM) II TURBO HBA1C KIT - 2.0

K130990 is an FDA 510(k) clearance for VARIANT(TM) II TURBO HBA1C KIT - 2.0, 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 29-day FDA review.

K130990 · Bio-Rad Laboratories, Inc., Clinical Systems Divis · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
29d
Days
Class 2
Risk

K130990 is an FDA 510(k) clearance for the VARIANT(TM) II TURBO HBA1C KIT - 2.0. 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 May 9, 2013 after a review of 29 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 - K130990

510(k) Number K130990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2013
Decision Date May 09, 2013
Days to Decision 29 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: 89d · This submission: 29d
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
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K122101 · Sebia · Dec 2012
K130990 · VARIANT(TM) II TURBO HBA1C KIT - 2.0
Download PDF FDA Summary Bio-Rad Laboratories,…