Cleared Special

K103116 - AP-2000

K103116 is the FDA 510(k) clearance for AP-2000 by Bestgen Biotech Corp.. It is a Class 2 Chemistry device (product code CGA) cleared through the Special 510(k) pathway after a 509-day FDA review.

K103116 · Bestgen Biotech Corp. · Chemistry device
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Mar 2012
Decision
509d
Days
Class 2
Risk

K103116 is an FDA 510(k) clearance for the AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Bestgen Biotech Corp. (Jung-He, Taipei County, TW). The FDA issued a Cleared decision on March 13, 2012 after a review of 509 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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: 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 Bestgen Biotech Corp. devices

Submission Details

510(k) Number K103116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2010
Decision Date March 13, 2012
Days to Decision 509 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
421d slower than avg
Panel avg: 88d · This submission: 509d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CGA Glucose Oxidase, Glucose

All 192
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