Cleared Special

K062972 - PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS

K062972 is an FDA 510(k) clearance for PRECINORM CK-MB AND PRECIPATH CK-MB CON..., manufactured by Roche Diagnostics Corp.. The device is a Class 1 Chemistry device with product code JJX cleared through the Special 510(k) pathway after a 14-day FDA review.

K062972 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
14d
Days
Class 1
Risk

K062972 is an FDA 510(k) clearance for the PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 13, 2006 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry 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 - K062972

510(k) Number K062972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2006
Decision Date October 13, 2006
Days to Decision 14 days
Submission Type Special
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
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

JJX Device Classification - Class 1, General Controls

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 481
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K062972 · PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS
Download PDF FDA Summary Roche Diagnostics Cor…