Cleared Traditional

Elecsys CYFRA 21-1 CalCheck 5 (K162173) - FDA 510(k) Clearance

Class I Immunology device.

K162173 · Roche Diagnostics · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Roche Diagnostics devices

Submission Details

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.

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 244
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K162173.
Beta-CrossLaps CalCheck 5
K170678 · Roche Diagnostics · Apr 2017
ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material
K143687 · Siemens Healthcare Diagnostics, Inc. · Jul 2015
Elecsys Progesterone III Cal Check 5
K150955 · Roche Diagnostics · May 2015
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
K150132 · Siemens Healthcare Diagnostics · Apr 2015
IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material
K143373 · Siemens Healthcare Diagnostics, Inc. · Feb 2015
IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material
K143636 · Siemens Healthcare Diagnostics, Inc. · Feb 2015