Cleared Traditional

K103044 - AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION

K103044 is an FDA 510(k) clearance for AP-1010 AND AP-1020 BLOOD GLUCOSE MONIT..., manufactured by Bestgen Biotech Corp.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 484-day FDA review.

K103044 · Bestgen Biotech Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
484d
Days
Class 2
Risk

K103044 is an FDA 510(k) clearance for the AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SO.... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Bestgen Biotech Corp. (Jung-He, Taipei County, TW). The FDA issued a Cleared decision on February 10, 2012 after a review of 484 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. 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 Bestgen Biotech Corp. devices

FDA 510(k) Submission Details - K103044

510(k) Number K103044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2010
Decision Date February 10, 2012
Days to Decision 484 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
396d slower than avg
Panel avg: 88d · This submission: 484d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBW Device Classification - Class 2, Special Controls

Product Code NBW System, Test, Blood Glucose, Over The Counter
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 - NBW System, Test, Blood Glucose, Over The Counter

All 459
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