Cleared Traditional

K091601 - ELECYS ANTI-CCP CALCHECK

K091601 is the FDA 510(k) clearance for ELECYS ANTI-CCP CALCHECK by Roche Diagnostics Corp.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K091601 · Roche Diagnostics Corp. · Chemistry device
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Sep 2009
Decision
114d
Days
Class 1
Risk

K091601 is an FDA 510(k) clearance for the ELECYS ANTI-CCP CALCHECK. 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 September 25, 2009 after a review of 114 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 Corp. devices

Submission Details

510(k) Number K091601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2009
Decision Date September 25, 2009
Days to Decision 114 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
26d slower than avg
Panel avg: 88d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 268
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