Cleared Traditional

K113636 - BLOOD GLUCOSE MONITORING SYSTEM (GLUCOS...

K113636 is the FDA 510(k) clearance for BLOOD GLUCOSE MONITORING SYSTEM (GLUCOS... by Philosys Co., Ltd.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 455-day FDA review.

K113636 · Philosys Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
455d
Days
Class 2
Risk

K113636 is an FDA 510(k) clearance for the BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE). Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Philosys Co., Ltd. (New York, US). The FDA issued a Cleared decision on March 8, 2013 after a review of 455 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 Philosys Co., Ltd. devices

Submission Details

510(k) Number K113636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2011
Decision Date March 08, 2013
Days to Decision 455 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
367d slower than avg
Panel avg: 88d · This submission: 455d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 191
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