Cleared Traditional

K101037 - EG V1 (BL) SELF MONITORING GLUCOSE TEST...

K101037 is an FDA 510(k) clearance for EG V1 (BL) SELF MONITORING GLUCOSE TEST..., manufactured by Eps Bio Technology Corp.. The device is a Class 2 Chemistry device with product code LFR cleared through the Traditional 510(k) pathway after a 404-day FDA review.

K101037 · Eps Bio Technology Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
May 2011
Decision
404d
Days
Class 2
Risk

K101037 is an FDA 510(k) clearance for the EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Eps Bio Technology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on May 23, 2011 after a review of 404 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 Eps Bio Technology Corp. devices

FDA 510(k) Submission Details - K101037

510(k) Number K101037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2010
Decision Date May 23, 2011
Days to Decision 404 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
316d slower than avg
Panel avg: 88d · This submission: 404d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFR Device Classification - Class 2, Special Controls

Product Code LFR Glucose Dehydrogenase, 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 - LFR Glucose Dehydrogenase, Glucose

All 56
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