(32 days)
No
The summary describes a liquid control product for calibrating and verifying an immunoassay, with no mention of AI or ML technologies.
No
Explanation: The device is described as an assayed control for calibration verification and assay range verification for immunoassay analyzers, indicating it is an in-vitro diagnostic (IVD) tool used for quality control and not for treating patients.
No.
The device is described as an "assayed control for use in calibration verification and for use in the verification of the assay range." It is used to check the performance of a diagnostic device (Elecsys Ferritin reagent), rather than performing a diagnosis itself.
No
The device description clearly states it is a "liquid product consisting of ferritin from human liver in a human serum matrix," indicating it is a physical reagent, not software.
Based on the provided information, the Elecsys Ferritin CalCheck 5 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "calibration verification" and "verification of the assay range" for the Elecsys Ferritin reagent on specific immunoassay analyzers. This indicates it's used in vitro (outside the body) to assess the performance of a diagnostic test.
- Device Description: It's a "liquid product consisting of ferritin from human liver in a human serum matrix." This is a biological material designed to be used in a laboratory setting for testing purposes.
- Predicate Device: The mention of a predicate device (Elecsys Ferritin CalCheck, K981281) which is also a CalCheck product, further supports its classification as an IVD. CalChecks are a common type of IVD used for quality control and calibration verification in diagnostic testing.
While it doesn't directly diagnose a patient condition, it is an essential component used to ensure the accuracy and reliability of an in vitro diagnostic test (the Elecsys Ferritin reagent). Therefore, it falls under the definition of an IVD device.
N/A
Intended Use / Indications for Use
The Elecsys® Ferritin 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 Ferritin reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Product codes
JJX
Device Description
The Elecsys® Ferritin CalCheck 5 is a liquid product consisting of ferritin from human liver in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Elecsys Ferritin CalCheck 5 was evaluated for value assignment and stability.
The data demonstrate that the performance of the Elecsys Ferritin CalCheck 5 is substantially equivalent to that of the predicate device, Elecsys Ferritin CalCheck (K981281).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Roche Diagnostics
K102267 Elecsys® Ferritin CalCheck 5
510(k) Summary
SEP 1_0 2010
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
name, address,
contact | Roche Diagnostics
9115 Hague Road, P.O. Box 50416
Indianapolis, IN 46250-0416
317-521-3501
Contact Person: Sarah Baumann
Phone: 317-521-3952
Fax: 317-521-2324
Email: sarah.baumann@roche.com
Secondary Contact: Stephanie Greeman
Phone: 317-521-2458
Fax: 317-521-2324
Email: stephanie.greeman@roche.com
Date Prepared: August 6, 2010 |
| Device name | Proprietary name: Elecsys® Ferritin CalCheck 5
Common name: Ferritin CalCheck 5
Classification name: Single (specified) analyte controls (assayed and
unassayed) |
| Predicate
device | The Elecsys Ferritin CalCheck 5 is substantially equivalent to other products
in commercial distribution intended for similar use. We claim equivalency to
the currently marketed Elecsys Ferritin CalCheck (K981281). |
| Device
description | The Elecsys Ferritin CalCheck 5 is a liquid product consisting of ferritin from
human liver in a human serum matrix. During manufacture, the analyte is
spiked into the matrix at the desired concentration levels. |
| Intended use | The Elecsys Ferritin 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 Ferritin reagent on the indicated Elecsys and cobas e
immunoassay analyzers. |
| | Continued on next page |
.
Confidential
Page 1 of 3
1
510(k) Summary, Continued
Table 1 below presents the similarities between Elecsys Ferritin CalCheck 5 Device and the predicate device, Elecsys Ferritin CalCheck (K981281). comparisonsimilarities
| Table 1. Device Comparison-Similarities between Candidate and Predicate Devices | |||
|---|---|---|---|
| Characteristic | Elecsys Ferritin CalCheck 5
(Candidate Device) | Elecsys Ferritin CalCheck
(K981281) |
|----------------|---------------------------------------------------|----------------------------------------|
| Analyte | Ferritin (human liver) | Same |
| Format | Liquid | Same |
| Handling | Mix gently by inversion to ensure
homogeneity. | Same |
| Matrix | Human serum matrix | Same |
| Device | Table 2 below presents the differences between Elecsys Ferritin CalCheck 5 |
|---|---|
| comparison- | |
| differences | and the predicate device, Elecsys Ferritin CalCheck (K981281). |
| Table 2. Device Comparison-Differences between Candidate and Predicate Devices | ||
|---|---|---|
| -------------------------------------------------------------------------------- | -- | -- |
| Characteristic | Elecsys Ferritin CalCheck 5
(Candidate Device) | Elecsys Ferritin CalCheck
(K981281) |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys Ferritin 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 Ferritin reagent on the
indicated Elecsys and cobas e
immunoassay analyzers. | For use in the verification of the
calibration established by the
Elecsys Ferritin reagent on
Elecsys 1010 or 2010
immunoassay analyzers. |
| Levels | Five | Three |
| Stability | Unopened:
• Store at 2-8°C until expiration
date | Unopened:
• Store at 2-8°C until expiration
date |
| | Opened:
• 20-25°C: 4 hours | Opened:
• 20-25°C: 5 hours |
Continued on next page
Confidential
2
:
・
.
510(k) Summary, Continued
| Performance
characteristics | The Elecsys Ferritin CalCheck 5 was evaluated for value assignment and
stability. |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The data demonstrate that the performance of the Elecsys Ferritin CalCheck 5
is substantially equivalent to that of the predicate device, Elecsys Ferritin
CalCheck (K981281). |
Confidential
. . . . . . . . . . .
·
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Roche Diagnostics c/o Sarah Baumann 9115 Hague Road Indianapolis, IN 46250
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
SEP 1 0 2010
Re: K102267
Trade Name: Elecsys Ferritin CalCheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, Reserved Product Codes: JJX Dated: August 6, 2010 Received: August 9, 2010
Dear Ms. Baumann:
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.
If your device is classified (sec above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
4
Page 2 –
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
C.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
510(k) Number (if known): _ K / 022267
SEP 1 0 2010
Device Name: Elecsys Ferritin CalCheck 5
Indications for Use: The Elecsys Ferritin 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 Ferritin reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Prescription Use Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102267
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