(162 days)
Elecsys Progesterone III CalCheck 5
Not Found
No
The device is a control material for an immunoassay analyzer, not a diagnostic or analytical tool that would typically incorporate AI/ML. The description focuses on the chemical composition and concentration levels of the control.
No
This device is an assayed control used for calibration verification and to verify the assay range of a diagnostic reagent, rather than directly treating or preventing a disease.
No
This device is described as an "assayed control" used for "calibration verification" and for "verification of the assay range" of a reagent on immunoassay analyzers. It is a control material, not a device that directly performs a diagnostic test on a patient sample to diagnose a condition.
No
The device is a lyophilized product consisting of cytokeratin in a human serum matrix, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "calibration verification and for use in the verification of the assay range established by the Elecsys CYFRA 21-1 reagent on the indicated Elecsys and cobas e immunoassay analyzers." This indicates it's used in vitro (outside the body) to assess the performance of a diagnostic test (the Elecsys CYFRA 21-1 reagent).
- Device Description: It's a "lyophilized product consisting of cytokeratin in a human serum matrix." This is a material designed to be used in a laboratory setting to interact with a diagnostic assay.
- Performance Studies: The document describes performance studies related to "Value assignment and stability studies," which are typical for IVD control materials to ensure they perform reliably.
- Predicate Device: The mention of a predicate device (K150955; Elecsys Progesterone III CalCheck 5) which is also a CalCheck product, further supports its classification as an IVD.
While it's not a diagnostic test itself that directly measures a patient's analyte, it is a critical component used with an IVD test to ensure the accuracy and reliability of the results. Therefore, it falls under the definition of an IVD device.
N/A
Intended Use / Indications for Use
The Elecsys CYFRA 21-1 CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys CYFRA 21-1 reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The Elecsys CYFRA 21-1 CalCheck 5 is a lyophilized product consisting of cytokeratin in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
CYFRA 21-1 CalCheck 5 is a lyophilized human serum matrix with added cytokeratin in five concentration ranges. The CalCheck includes:
- o CYFRA 21-1 CalCheck 1: approximately
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 12, 2017
Roche Diagnostics Mr. Adam Clark Regulatory Affairs Consultant 9115 Hague Road Indianapolis, IN 46250
Re: K162173
Trade/Device Name: Elecsys CYFRA 21-1 CalCheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: I. Reserved Product Code: JJX Dated: December 15, 2016 Received: December 16, 2016
Dear Mr. Clark:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/7 description: The image contains the name "Kelly Oliner" in a simple, sans-serif font. The text is positioned slightly above and to the right of a large, faded "FDA" watermark. The watermark is light blue and spans the majority of the image's width, with the text appearing to overlay it.
FOR
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162173
Device Name Elecsys CYFRA 21-1 CalCheck 5
Indications for Use (Describe)
The Elecsys CYFRA 21-1 CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys CYFRA 21-1 reagent on the indicated Elecsys and cobas e immunoassay analyzers.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter Name | Roche Diagnostics |
|---|---|
| Address | 9115 Hague Road |
| Indianapolis, IN 46250 | |
| Contact | Adam Clark |
| Phone: (317) 521-4371 | |
| FAX: (317) 521-2324 | |
| Email: adam.clark@roche.com | |
| Date Prepared | June 30, 2016 |
| Proprietary Name | 1) Elecsys CYFRA 21-1 CalCheck 5 |
| Common Name | 1) CYFRA 21-1 CalCheck 5 |
| Classification Name | 1) Single (specified) analyte Controls (assayed and unassayed) |
| Product Codes | 1) JJX; 862.1660 |
| Predicate Devices | 1) Elecsys Progesterone III CalCheck 5 |
| Establishment Registration | Roche Diagnostics GmbH in Mannheim, Germany: 9610126 |
| Roche Diagnostics GmbH in Penzberg, Germany: 9610529 | |
| Roche Diagnostics in the United States: 1823260 |
4
DEVICE DESCRIPTION 1.
The Elecsys CYFRA 21-1 CalCheck 5 is a lyophilized product consisting of cytokeratin in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
1.1. CalCheck
CYFRA 21-1 CalCheck 5 is a lyophilized human serum matrix with added cytokeratin in five concentration ranges. The CalCheck includes:
- o CYFRA 21-1 CalCheck 1: approximately