Cleared Traditional

K162173 - Elecsys CYFRA 21-1 CalCheck 5

K162173 is an FDA 510(k) clearance for Elecsys CYFRA 21-1 CalCheck 5, manufactured by Roche Diagnostics. The device is a Class 1 Immunology device with product code JJX cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K162173 · Roche Diagnostics · Immunology device
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Jan 2017
Decision
162d
Days
Class 1
Risk

K162173 is an FDA 510(k) clearance for the Elecsys CYFRA 21-1 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 January 12, 2017 after a review of 162 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K162173

510(k) Number K162173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2016
Decision Date January 12, 2017
Days to Decision 162 days
Submission Type Traditional
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
58d slower than avg
Panel avg: 104d · This submission: 162d
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 403
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