Cleared Traditional

K934592 - EPOC 2000 POINT-OF-CARE ANALYZER AND EP...

K934592 is an FDA 510(k) clearance for EPOC 2000 POINT-OF-CARE ANALYZER AND EP..., manufactured by Abaxis, Inc.. The device is a Class 1 Chemistry device with product code JJG cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K934592 · Abaxis, Inc. · Chemistry device
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Apr 1994
Decision
194d
Days
Class 1
Risk

K934592 is an FDA 510(k) clearance for the EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR. Classified as Analyzer, Chemistry, Centrifugal, For Clinical Use (product code JJG), Class I - General Controls.

Submitted by Abaxis, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 6, 1994 after a review of 194 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2140 - 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 Abaxis, Inc. devices

FDA 510(k) Submission Details - K934592

510(k) Number K934592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1993
Decision Date April 06, 1994
Days to Decision 194 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 88d · This submission: 194d
Pathway characteristics
Predicate-based equivalence.

JJG Device Classification - Class 1, General Controls

Product Code JJG Analyzer, Chemistry, Centrifugal, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2140
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 - JJG Analyzer, Chemistry, Centrifugal, For Clinical Use

All 20
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