Cleared Traditional

K090699 - VARIANT II TURBO HBA1C KIT KIT-20 AND W...

K090699 is the FDA 510(k) clearance for VARIANT II TURBO HBA1C KIT KIT-20 AND W... by Bio-Rad Laboratories, Inc.. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K090699 · Bio-Rad Laboratories, Inc. · Chemistry device
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Jul 2009
Decision
132d
Days
Class 2
Risk

K090699 is an FDA 510(k) clearance for the VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2.... 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 July 27, 2009 after a review of 132 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.

View all Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K090699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2009
Decision Date July 27, 2009
Days to Decision 132 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
44d slower than avg
Panel avg: 88d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 117
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K090699.
TINA-QUANT HBA1C GEN.2
K110313 · Roche Diagnostics · Dec 2011
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
K110934 · Siemens Healthcare Diagnostics · Aug 2011
DIMENSIONS HB1C KIT, MODEL DF105A
K102510 · Siemens Healthcare Diagnostics · May 2011
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
K072714 · Roche Diagnostics Corp. · Apr 2008
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
K070452 · Bio-Rad Laboratories, Inc. · May 2007
VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0
K063400 · Bio-Rad Laboratories, Inc. · Dec 2006