(78 days)
AuraFlex Ferritin is a fluorescent enzyme immunoassay for the quantitative determination of ferritin in human serum or plasma using the AuraFlex System.
Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemachromatosis (iron overload) and iron deficiency anemia.
Fluorescent immunoassay reagents.
Here's the analysis of the provided information regarding the AuraFlex® Ferritin device:
Due to the nature of the device (immunoassay for Ferritin), many of the acceptance criteria points (like expert readers, adjudication, MRMC studies) are not applicable as this is not an image-based or human-interpretive diagnostic device. The study described focuses on the analytical performance of the assay.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Correlation with an established predicate device (analytical performance) | 0.99 (AuraFlex® Ferritin = 0.99 Other Ferritin assay + 1.9 ng/ml (ug/1)) |
Study Details
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Sample size used for the test set and the data provenance:
- Sample size: 94 human serum samples.
- Data provenance: Not explicitly stated, but the samples were human serum. The document doesn't specify the country of origin or if it was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is an immunoassay, and "ground truth" for its analytical performance is typically established by comparison to a reference method or a predicate device, not by expert interpretation.
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Adjudication method for the test set:
- Not applicable. The "ground truth" was established via a comparative study with another Ferritin assay.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is an in vitro diagnostic (IVD) assay, not an AI-assisted diagnostic tool requiring human interpretation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The study performed was a standalone analytical performance study of the AuraFlex® Ferritin assay. It compared the results of the new assay directly against an "Other Ferritin assay" without human-in-the-loop performance measurement.
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The type of ground truth used:
- The "ground truth" for demonstrating substantial equivalence was established by comparison to an "Other Ferritin assay," which implicitly served as the reference or predicate method. This is an analytical comparison rather than a clinical ground truth like pathology or outcome data.
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The sample size for the training set:
- Not applicable. This device is an immunoassay, not a machine learning or AI-driven algorithm that requires a training set in the conventional sense. The "training" here would be related to assay optimization and validation during development, not data-driven model training.
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How the ground truth for the training set was established:
- Not applicable (as per point 7).
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10.0 510(K) SUMMARY
FEB 1 7 1998
A 510(k) Summary follows for the AuraFlex® Ferritin reagents described in this submission.
510(k) Summarv AuraFlex® Ferritin
:
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Submitter's Name: Alfa Biotech (UK) Ltd
Submitter's Address: Unit 4, Spring Lakes Estate, Deadbrook Lane, Aldershot, Hants, GU12 4UH
Submitter's Telephone: (44) 1252 341477
Submitter's Contact: Mr M John Taylor
Date 510(k) Summary Prepared: 24 November 1997
Device Trade or Proprietary Name: AuraFlex® Ferritin
Device Common or Usual Name: Immunoassay for Ferritin
Device Classification Name: Ferritin Test System
Device Description: Fluorescent immunoassay reagents.
Device Intended Use: The AuraFlex® Ferritin assay is a fluorescent immunoassay for the quantitative determination of Ferritin in human serum or plasma using the AuraFlex System.
Data Upon Which Substantial Equivalence was Determined:
A comparison study was conducted in which 94 human serum samples were assayed using the AuraFlex® Ferritin assay in singlicate. Results between the two assays showed a correlation of 0.99 (AuraFlex® Ferritin = 0.99 Other Ferritin assay + 1.9 ng/ml (ug/1).
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure embracing a globe, symbolizing the department's mission to protect and promote the health and well-being of all Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
M. John Taylor Director of Quality and Regulatory Affairs Alfa Biotech (UK) Ltd. 4 Spring Lakes Estate Deadbrook Lane Aldershot, Hampshire GU12 4UH UNITED KINGDOM
FFB 17 1998
K974505 Re : Trade Name: AuraFlex® Ferritin Regulatory Class: II Product Code: DBF 82 November 24, 1997 Dated: December 01, 1997 Received:
Dear Mr. Taylor:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ...... .............................................................................................................................................................
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Page of
510(k) Number (if known): K974505
Device Name: AURAFLEX Ferritin
Indications for Use:
AuraFlex Ferritin is a fluorescent enzyme immunoassay for the quantitative determination of ferritin in human serum or plasma using the AuraFlex System.
Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemachromatosis (iron overload) and iron deficiency anemia.
(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Madeni
(Division Sign-Off)
Division of Clinical Laboratory Devices K974505
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
:
t
§ 866.5340 Ferritin immunological test system.
(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).