(130 days)
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No
The summary describes a quantitative in vitro assay for measuring specific immunoglobulins and calculating a ratio, which is a standard laboratory test and does not mention any AI or ML components.
No.
The device is described as a quantitative in vitro assay used for measurement and monitoring, not for treating or providing therapy.
Yes
The device is described as a "quantitative in vitro assay" used for the "measurement of IgA Kappa" and "IgA Lambda" to "calculate the IgA Kappa / IgA Lambda ratio" for "monitoring previously diagnosed IgA multiple myeloma patients." This indicates its role in assessing a patient's health status for medical purposes, which is a characteristic of a diagnostic device.
No
The device is described as an "in vitro assay performed on the Binding Site SPAPLUS," which indicates it is a laboratory test involving reagents and a specific hardware analyzer (SPAPLUS), not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- "in vitro assay": The intended use explicitly states that the devices are "quantitative in vitro assays". This is a key characteristic of IVDs, meaning they are used to examine samples taken from the body (in this case, serum) outside of the body.
- Measurement of analytes in a biological sample: The devices measure specific substances (IgA Kappa and IgA Lambda) in a biological sample (serum).
- Used for medical purposes: The intended use describes how the measurements and the calculated ratio are used in the monitoring of previously diagnosed IgA multiple myeloma patients and in conjunction with other laboratory tests and clinical evaluations. This indicates a medical purpose.
Therefore, based on the provided information, the Hevylite Human IgA Kappa and Hevylite Human IgA Lambda assays clearly fit the definition of In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Hevylite Human IgA Kappa is a quantitative in vitro assay performed on the Binding Site SPAPLUS for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgA Kappa is used alongside Hevylite Human IgA Lambda to calculate the IgA Kappa / IgA Lambda ratio. The Hevylite Human IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.
Hevylite Human IgA Lambda is a quantitative in vitro assay performed on The Binding Site SPAPLUS for the measurement of IgA Lambda (IgA heavy chain and Lambda light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgA Lambda is used alongside Hevylite Human IgA Kappa to calculate the IgA Kappa / IgA Lambda ratio. The Hevylite Human IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.
Product codes
OPX, OPY
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird design, composed of three overlapping profiles facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10, 2015
The Binding Site Group Ltd. c/o Stephanie Thouless Regulatory Affairs Officer 8 Calthorpe Road Edgbaston B15 1QT UK
Re: K151759
Trade/Device Name: Hevylite® Human IgA Kappa Kit For Use On SPAPLUS, Hevylite® Human IgA Lambda Kit For Use On SPAPLUS Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E immunological test system Regulatory Class: II Product Code: OPX, OPY Dated: June 26, 2015 Received: June 29, 2015
Dear Ms. Thouless:
This letter corrects our substantially equivalent letter of November 6, 2015.
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
1
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 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 Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| Indications for Use | |
| See PRA Statement below. | |
| 510(k) Number (if known) | |
| Device Name | |
| Hevylite Human IgA Kappa Kit for use on SPAPLUS | |
| Hevylite Human IgA Lambda Kit fot use on SPAPLUS | |
| Indications for Use (Describe) | |
| Hevylite Human IgA Kappa is a quantitative in vitro assay performed on the Binding Site SPAPLUS for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgA Kappa is used alongside Hevylite Human IgA Lambda to calculate the IgA Kappa / IgA Lambda ratio. The Hevylite Human IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments. | |
| Hevylite Human IgA Lambda is a quantitative in vitro assay performed on The Binding Site SPAPLUS for the measurement of IgA Lambda (IgA heavy chain and Lambda light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgA Lambda is used alongside Hevylite Human IgA Kappa to calculate the IgA Kappa / IgA Lambda ratio. The Hevylite Human IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments | |
| 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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