(116 days)
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No
The summary describes a quantitative in vitro diagnostic assay for measuring specific proteins in serum using a laboratory analyzer. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The focus is on the analytical performance of the assay kit.
No
The device is an in vitro diagnostic (IVD) kit for quantitative measurement of markers in serum, not for treating a condition.
No
The device is explicitly stated as "not established for the diagnosis, monitoring and prognosis of Waldenström's macroglobulinaemia," which indicates it is not a diagnostic device. Instead, it is intended for quantitative measurement in previously diagnosed cases.
No
The device description is not provided, but the intended use clearly states it is a "Kit" for quantitative in vitro measurement using an "analyser," which implies physical components and reagents, not just software.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- "in vitro measurement": The intended use explicitly states "quantitative in vitro measurement". This is a key characteristic of IVD devices, meaning the test is performed outside of a living organism, typically on biological samples like serum.
- "in serum": The test is performed on a biological sample (serum), which is another defining feature of IVDs.
- "using the Binding Site Optilite analyser": This indicates the device is a reagent kit designed to be used with a specific analytical instrument, which is common for IVD tests.
- "The test result is to be used with previously diagnosed Waldenström's macroglobulinaemia": While it states it's not for diagnosis, monitoring, or prognosis, the test result is intended to be used in a clinical context related to a specific medical condition. This aligns with the purpose of IVDs, which are used to provide information about a patient's health status.
Therefore, the intended use clearly describes a test performed in vitro on a biological sample to provide information relevant to a medical condition, which fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Optilite Hevylite IgM Kappa Kit is intended for the quantitative in vitro measurement of IgM kappa (combined μ heavy and k light chain) in serum using the Binding Site Optilite analyser. The test result is to be used with previously diagnosed Waldenström's macroglobulinaemia. The test result should be used in conjunction with other laboratory and clinical findings.
This assay has not been established for the diagnosis, monitoring and prognosis of Waldenström's macroglobulinaemia.
The Optilite Hevylite IgM Lambda Kit is intended for the quantitative in vitro measurement of IgM lambda (combined u heavy and a light chain) in serum using the Binding Site Optilite analyser. The test result is to be used with previously diagnosed Waldenström's macroglobulinaemia. The test result should be used in conjunction with other laboratory and clinical findings.
This assay has not been established for the diagnosis, monitoring and prognosis of Waldenström's macroglobulinaemia.
Product codes
PDE, PDF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2015
THE BINDING SITE GROUP LTD STEPHANIE THOULESS REGULATORY AFFAIRS 8 CALTHORPE RD EDGBASTON BIRMINGHAM B15 1QT UK
Re: K152389
Trade/Device Name: Optilite® Hevylite® IgM Kappa Kit, Optilite® Hevylite® IgM Lambda Kit Regulation Number: 21 CFR § 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E immunological test system Regulatory Class: II Product Code: PDE, PDF Dated: November 16, 2015 Received: November 18, 2015
Dear Ms. Thouless:
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 (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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/ResourcesforYou/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,
Kelly Oliner -S
FOR
Leonthena Carrington, MBA, MS, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | Form Approved: OMB No. 0910-0120 |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K152389 |
| Device Name | Optilite Hevylite IgM Kappa Kit |
| Optilite Hevylite IgM Lambda Kit | |
| Indications for Use (Describe) | |
| The Optilite Hevylite IgM Kappa Kit is intended for the quantitative in vitro measurement of IgM kappa (combined μ heavy and k light chain) in serum using the Binding Site Optilite analyser. The test result is to be used with previously diagnosed Waldenström's macroglobulinaemia. The test result should be used in conjunction with other laboratory and clinical findings. | |
| This assay has not been established for the diagnosis, monitoring and prognosis of Waldenström's macroglobulinaemia. | |
| The Optilite Hevylite IgM Lambda Kit is intended for the quantitative in vitro measurement of IgM lambda (combined u heavy and a light chain) in serum using the Binding Site Optilite analyser. The test result is to be used with previously diagnosed Waldenström's macroglobulinaemia. The test result should be used in conjunction with other laboratory and clinical findings. | |
| This assay has not been established for the diagnosis, monitoring and prognosis of Waldenström's macroglobulinaemia. | |
| 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) |
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