Cleared Special

K091910 - PICCOLO MAGNESIUM TEST SYSTEM (FDA 510(k) Clearance)

Class I Chemistry device.

K091910 · Abaxis, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
98d
Days
Class 1
Risk

K091910 is an FDA 510(k) clearance for the PICCOLO MAGNESIUM TEST SYSTEM. Classified as Photometric Method, Magnesium (product code JGJ), Class I - General Controls.

Submitted by Abaxis, Inc. (Union City, US). The FDA issued a Cleared decision on October 1, 2009 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1495 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Abaxis, Inc. devices

Submission Details

510(k) Number K091910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2009
Decision Date October 01, 2009
Days to Decision 98 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
10d slower than avg
Panel avg: 88d · This submission: 98d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JGJ Photometric Method, Magnesium
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1495
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.