Cleared Traditional

K082275 - CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONI...

K082275 is the FDA 510(k) clearance for CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONI... by Infopia Co, Ltd.. It is a Class 2 Chemistry device (product code LCP) cleared through the Traditional 510(k) pathway after a 521-day FDA review.

K082275 · Infopia Co, Ltd. · Chemistry device
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Jan 2010
Decision
521d
Days
Class 2
Risk

K082275 is an FDA 510(k) clearance for the CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM.... Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Infopia Co, Ltd. (Great Neck, US). The FDA issued a Cleared decision on January 14, 2010 after a review of 521 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Infopia Co, Ltd. devices

Submission Details

510(k) Number K082275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2008
Decision Date January 14, 2010
Days to Decision 521 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
433d slower than avg
Panel avg: 88d · This submission: 521d
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 137
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