Cleared Traditional

K094031 - ELECSYS FOLATE III CALCHECK 5

K094031 is an FDA 510(k) clearance for ELECSYS FOLATE III CALCHECK 5, manufactured by Roche Diagnostics. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K094031 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
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Apr 2010
Decision
118d
Days
Class 1
Risk

K094031 is an FDA 510(k) clearance for the ELECSYS FOLATE III CALCHECK 5. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on April 27, 2010 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostics devices

FDA 510(k) Submission Details - K094031

510(k) Number K094031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2009
Decision Date April 27, 2010
Days to Decision 118 days
Submission Type Traditional
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
30d slower than avg
Panel avg: 88d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

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 436
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K094031.
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