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)
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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
Combination Product No
PCCP Authorized No
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 225
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