Cleared Traditional

K093297 - EPOC BGEM

K093297 is the FDA 510(k) clearance for EPOC BGEM by Epocal, Inc.. It is a Class 1 Chemistry device (product code KHP) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K093297 · Epocal, Inc. · Chemistry device
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Jun 2010
Decision
231d
Days
Class 1
Risk

K093297 is an FDA 510(k) clearance for the EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE. Classified as Acid, Lactic, Enzymatic Method (product code KHP), Class I - General Controls.

Submitted by Epocal, Inc. (Ottawa, CA). The FDA issued a Cleared decision on June 9, 2010 after a review of 231 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1450 - 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. Standard predicate reliance. 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 Epocal, Inc. devices

Submission Details

510(k) Number K093297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2009
Decision Date June 09, 2010
Days to Decision 231 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
143d slower than avg
Panel avg: 88d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KHP Acid, Lactic, Enzymatic Method
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1450
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KHP Acid, Lactic, Enzymatic Method

All 13
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