Cleared Traditional

K100304 - ST AIA PACK HBA1C

K100304 is an FDA 510(k) clearance for ST AIA PACK HBA1C, manufactured by Tosoh Bioscience, Inc.. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K100304 · Tosoh Bioscience, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
205d
Days
Class 2
Risk

K100304 is an FDA 510(k) clearance for the ST AIA PACK HBA1C. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Tosoh Bioscience, Inc. (South San Franciso, US). The FDA issued a Cleared decision on August 27, 2010 after a review of 205 days - an extended review cycle.

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 Tosoh Bioscience, Inc. devices

FDA 510(k) Submission Details - K100304

510(k) Number K100304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2010
Decision Date August 27, 2010
Days to Decision 205 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 88d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 155
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K100304.
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
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K102510 · Siemens Healthcare Diagnostics · May 2011
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730
K090699 · Bio-Rad Laboratories, Inc. · Jul 2009
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
K090413 · Bayer Healthcare, LLC · May 2009
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
K072714 · Roche Diagnostics Corp. · Apr 2008