Cleared Traditional

K132633 - OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM

K132633 is an FDA 510(k) clearance for OKMETER DIRECT BLOOD GLUCOSE MONITORING..., manufactured by Ok Biotech Co., Ltd.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 357-day FDA review.

K132633 · Ok Biotech Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
357d
Days
Class 2
Risk

K132633 is an FDA 510(k) clearance for the OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Ok Biotech Co., Ltd. (Hsinchu City, TW). The FDA issued a Cleared decision on August 14, 2014 after a review of 357 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Ok Biotech Co., Ltd. devices

FDA 510(k) Submission Details - K132633

510(k) Number K132633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2013
Decision Date August 14, 2014
Days to Decision 357 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
269d slower than avg
Panel avg: 88d · This submission: 357d
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 505
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