Cleared Traditional

K213061 - SuperCheck Pro Blood Glucose Monitoring...

K213061 is an FDA 510(k) clearance for SuperCheck Pro 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 380-day FDA review.

K213061 · Ok Biotech Co., Ltd. · Chemistry device
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Oct 2022
Decision
380d
Days
Class 2
Risk

K213061 is an FDA 510(k) clearance for the SuperCheck Pro 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 October 7, 2022 after a review of 380 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 - K213061

510(k) Number K213061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2021
Decision Date October 07, 2022
Days to Decision 380 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
292d slower than avg
Panel avg: 88d · This submission: 380d
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.

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All 271
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