Cleared Dual Track

K200865 - Piccolo Potassium Test System (FDA 510(k) Clearance)

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

K200865 · Abaxis, Inc. · Chemistry device
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Oct 2021
Decision
567d
Days
Class 2
Risk

K200865 is an FDA 510(k) clearance for the Piccolo Potassium Test System. Classified as Test, System, Potassium, Enzymatic Method (product code MZV), Class II - Special Controls.

Submitted by Abaxis, Inc. (Union City, US). The FDA issued a Cleared decision on October 20, 2021 after a review of 567 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1600 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Abaxis, Inc. devices

Submission Details

510(k) Number K200865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2020
Decision Date October 20, 2021
Days to Decision 567 days
Submission Type Dual Track
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
479d slower than avg
Panel avg: 88d · This submission: 567d
Pathway characteristics

Device Classification

Product Code MZV Test, System, Potassium, Enzymatic Method
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1600
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.

Regulatory Consultant

Zoetis, LLC (Acquirer of Abaxis, Inc.)
Julie Schoell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.