Cleared Special

K050387 - ROCHE DIAGNOSTICS ELECSYS PRECICONTROL ...

K050387 is the FDA 510(k) clearance for ROCHE DIAGNOSTICS ELECSYS PRECICONTROL ... by Roche Diagnostics Corp.. It is a Class 1 Immunology device (product code JJY) cleared through the Special 510(k) pathway after a 69-day FDA review.

K050387 · Roche Diagnostics Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
69d
Days
Class 1
Risk

K050387 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 25, 2005 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology 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.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K050387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2005
Decision Date April 25, 2005
Days to Decision 69 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 104d · This submission: 69d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 318
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