(15 days)
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No
The summary describes a set of calibration verification solutions for immunoassay analyzers, with no mention of AI or ML technology.
No
The device is described as a set of calibration verification solutions for immunoassay analyzers, which are used to verify the calibration of reagents. It is not intended for the treatment or prevention of disease.
No
The device is used for calibration verification of immunoassay analyzers, not for diagnosing medical conditions in patients. It supports diagnostic devices but is not one itself.
No
The device description explicitly states it is a "set of calibration verification solutions comprised of three levels," indicating it is a physical product (solutions) and not solely software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's "For use in the verification of the calibration established by the Elecsys Folate II reagent on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers." This indicates it's used in vitro (outside the body) to assess the performance of another diagnostic device (the Elecsys Folate II reagent and analyzers).
- Device Description: It's described as a "set of calibration verification solutions comprised of three levels, each with defined folate levels." These solutions are used to test the accuracy of the diagnostic process.
- Predicate Device: The mention of a predicate device (K974384; Elecsys Folate CalCheck) strongly suggests this device is also an IVD, as predicate devices are typically used for comparison in the regulatory process for new IVDs.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use and nature of the device clearly align with the definition of an IVD, which are reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. In this case, it's used to ensure the accuracy of a diagnostic test for folate levels.
N/A
Intended Use / Indications for Use
For use in the verification of the calibration established by the Elecsys Folate II reagent on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.
Product codes
JJX
Device Description
The Elecsys Folate II CalCheck II is a set of calibration verification solutions comprised of three levels, each with defined folate 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
Not Found
Key Metrics
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.
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DEC 17 2004
510(k) Summary - Elecsys® Folate II CalCheck II
| 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 Rd | |
| Indianapolis IN 46250 | |
| (317) 521-3544 | |
| Contact person: Kay A. Taylor | |
| Date prepared: December 1, 2004 | |
| Device Name | Proprietary name: Roche Diagnostics Elecsys® Folate II CalCheck II |
| Common name: Calibration Verification Material | |
| Classification name: Single (specified) Analyte Controls (Assayed and Unassayed) | |
| Device description | The Elecsys Folate II CalCheck II is a set of calibration verification solutions comprised of three levels, each with defined folate levels. |
| Intended use | For use in the verification of the calibration established by the Elecsys Folate II reagent on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers. |
| Predicate Device | We claim substantial equivalence to the currently marketed Elecsys Folate CalCheck. (K974384). |
| Device Comparison | The table below illustrates the similarities between the Elecsys Folate CalCheck (K974384) and the Elecsys Folate II CalCheck II (modified device). |
...
1
510(k) Summary - Elecsys® Folate II CalCheck II, continued
:
| Topic | Elecsys® Folate CalCheck
(K974384) | Elecsys® Folate II CalCheck II
(Modified Device) |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for
Use | For use in the verification of the
calibration established by the... Elecsys Folate reagent on the
Elecsys 2010 Elecsys Folate II reagent on the
MODULAR ANALYTICS E170. | For use in the verification of the
calibration established by the Elecsys
Folate II reagent on the Elecsys 2010
and MODULAR ANALYTICS E170
immunoassay analyzers. |
| Matrix | Buffer with human albumin | Human serum |
| Storage Form | Liquid | Lypholized |
| Levels | Low: 1.5 ng/ml
Mid: 8.7 ng/ml
High: 16.0 ng/ml | Low: 2.0 ng/ml
Mid: 7.5 ng/ml
High:15.3 ng/ml |
| Standardization | The Elecsys Folate II assay has been
standardized against the Elecsys
Folate assay. The Elecsys Folate
assay was standardized against a
commercially available radiobinding
folate assay. Note: the previously used
radiobinding folate assay is no longer
available. | The Elecsys Folate II assay has been
standardized against the Elecsys
Folate assay. |
| Stability | Store at 2-8°C unopened up to the
expiration date.
Opened: 5 hours at 20-25°C | Same |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 17 2004
Ms. Kay A. Taylor, MT (ASCP), RAC Regulatory Principal Roche Diagnostics Corp. Centralized Diagnostics 9115 Hague Road Indianapolis, IN 46250
K043320 Re:
Trade/Device Name: Roche Elecsys Folate II CalCheckII Regulation Number: 21 CFR 862.1660 Regulation Name: Control Material Regulatory Class: Class I Product Code: JJX Dated: December 1, 2004 Received: December 2, 2004
Dear Ms. Taylor:
We have reviewed your Section 510(k) premarket notification of intent to market the device w one reviewed your we 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 (see above) into either 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sincerely yours,
Cornelia B. Lorks
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K043320
Device Name: Roche Elecsys Folate II CalCheck II
Indications For Use:
For use in the verification of the calibration established by the Elecsys Folate II reagent on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) K043320