Cleared Special

K043320 - MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II

K043320 is an FDA 510(k) clearance for MODIFICATION TO ROCHE ELECSYS FOLATE II..., 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 15-day FDA review.

K043320 · Roche Diagnostics Corp. · Chemistry device
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Dec 2004
Decision
15d
Days
Class 1
Risk

K043320 is an FDA 510(k) clearance for the MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II. 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 December 17, 2004 after a review of 15 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.

View all Roche Diagnostics Corp. devices

FDA 510(k) Submission Details - K043320

510(k) Number K043320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2004
Decision Date December 17, 2004
Days to Decision 15 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
73d faster than avg
Panel avg: 88d · This submission: 15d
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 421
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