Cleared Traditional

K093297 - EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE

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

K093297 · Epocal, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K093297

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.

KHP Device Classification - Class 1, General Controls

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 20
Devices cleared under the same product code (KHP) and FDA review panel - the closest regulatory comparables to K093297.
NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM
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NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
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LACTATE PRO SYSTEM
K980908 · Kdk Corp. · Sep 1998
I-STAT LACTATE TEST
K982071 · I-Stat Corp. · Jun 1998
LACTEST I
K971944 · Jwt, Inc. · Dec 1997