Cleared Traditional

ACCELERATOR APS (K093318) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K093318 · Abbott Laboratories · Chemistry device
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Feb 2010
Decision
119d
Days
Class 2
Risk

K093318 is an FDA 510(k) clearance for the ACCELERATOR APS. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on February 19, 2010 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1600 - 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 Abbott Laboratories devices

Submission Details

510(k) Number K093318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2009
Decision Date February 19, 2010
Days to Decision 119 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
31d slower than avg
Panel avg: 88d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEM Electrode, Ion Specific, Potassium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1600
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 - CEM Electrode, Ion Specific, Potassium

All 30
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