Cleared Traditional

K040115 - PICCOLO MAGNESIUM TEST SYSTEM (FDA 510(k) Clearance)

Class I Chemistry device.

K040115 · Abaxis, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
10d
Days
Class 1
Risk

K040115 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 January 30, 2004 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1495 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abaxis, Inc. devices

Submission Details

510(k) Number K040115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2004
Decision Date January 30, 2004
Days to Decision 10 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
78d faster than avg
Panel avg: 88d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

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.