Cleared Special

MODIFICATION TO: INSTAREAD LITHIUM SYSTEM (K050338) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K050338 · Akers Biosciences, Inc. · Chemistry device
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Mar 2005
Decision
21d
Days
Class 2
Risk

K050338 is an FDA 510(k) clearance for the MODIFICATION TO: INSTAREAD LITHIUM SYSTEM. Classified as Flame Photometry, Lithium (product code JIH), Class II - Special Controls.

Submitted by Akers Biosciences, Inc. (Thorofare, US). The FDA issued a Cleared decision on March 4, 2005 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3560 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Akers Biosciences, Inc. devices

Submission Details

510(k) Number K050338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2005
Decision Date March 04, 2005
Days to Decision 21 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JIH Flame Photometry, Lithium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3560
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.