Cleared Special

K003488 - SYNCHRON CONTROL

K003488 is an FDA 510(k) clearance for SYNCHRON CONTROL, manufactured by Beckman Coulter, Inc.. The device is a Class 1 Toxicology device with product code JJY cleared through the Special 510(k) pathway after a 14-day FDA review.

K003488 · Beckman Coulter, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
14d
Days
Class 1
Risk

K003488 is an FDA 510(k) clearance for the SYNCHRON CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on November 27, 2000 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1660 - the FDA toxicology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K003488

510(k) Number K003488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2000
Decision Date November 27, 2000
Days to Decision 14 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 87d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 671
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K003488.
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K001249 · Consolidated Technologies of Wisconsin · Nov 2000
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K002460 · Bio-Rad · Aug 2000
DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3
K002174 · Casco-Nerl Diagnostics Corporation (Maine) · Aug 2000
K003488 · SYNCHRON CONTROL
Download PDF FDA Summary Beckman Coulter, Inc.