Cleared Traditional

PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER (K013654) - FDA 510(k) Clearance

Class I Toxicology device.

K013654 · Precision Systems, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
211d
Days
Class 1
Risk

K013654 is an FDA 510(k) clearance for the PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER. Classified as Analyzer, Chemistry, Micro, For Clinical Use (product code JJF), Class I - General Controls.

Submitted by Precision Systems, Inc. (Natick, US). The FDA issued a Cleared decision on June 5, 2002 after a review of 211 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2170 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Precision Systems, Inc. devices

Submission Details

510(k) Number K013654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2001
Decision Date June 05, 2002
Days to Decision 211 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 87d · This submission: 211d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJF Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2170
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 - JJF Analyzer, Chemistry, Micro, For Clinical Use

All 56
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