Cleared Traditional

K022312 - PICCOLO PHOSPHORUS TEST SYSTEM

K022312 is an FDA 510(k) clearance for PICCOLO PHOSPHORUS TEST SYSTEM, manufactured by Abaxis, Inc.. The device is a Class 1 Chemistry device with product code CEO cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K022312 · Abaxis, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Sep 2002
Decision
50d
Days
Class 1
Risk

K022312 is an FDA 510(k) clearance for the PICCOLO PHOSPHORUS TEST SYSTEM. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Abaxis, Inc. (Union City, US). The FDA issued a Cleared decision on September 5, 2002 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1580 - 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

FDA 510(k) Submission Details - K022312

510(k) Number K022312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2002
Decision Date September 05, 2002
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

CEO Device Classification - Class 1, General Controls

Product Code CEO Phosphomolybdate (colorimetric), Inorganic Phosphorus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1580
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.

Regulatory Peers - CEO Phosphomolybdate (colorimetric), Inorganic Phosphorus

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