Cleared Traditional

K023639 - PICCOLO TRIGLYCERIDES TEST SYSTEM (FDA 510(k) Clearance)

Class I Chemistry device.

K023639 · Abaxis, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
86d
Days
Class 1
Risk

K023639 is an FDA 510(k) clearance for the PICCOLO TRIGLYCERIDES TEST SYSTEM. Classified as Colorimetric Method, Triglycerides (product code JGY), Class I - General Controls.

Submitted by Abaxis, Inc. (Union City, US). The FDA issued a Cleared decision on January 24, 2003 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1705 - 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 K023639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2002
Decision Date January 24, 2003
Days to Decision 86 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
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JGY Colorimetric Method, Triglycerides
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1705
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.