(62 days)
Not Found
K/DEN: not applicable
No
The summary describes a quantitative in vitro assay for measuring specific immunoglobulins using a nephelometer. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is an in vitro assay used for measurement and monitoring, not for treating any condition.
Yes
The text explicitly states the assays are used for "measurement of IgA Kappa" and "measurement of IgA Lambda" in serum, and the resulting ratio is used "when monitoring previously diagnosed IgA multiple myeloma" and "in conjunction with other laboratory tests and clinical evaluations," indicating their use in assessing a patient's condition.
No
The device is described as an in vitro assay performed on a nephelometer, which is a hardware instrument. The description focuses on the assay's components and intended use in conjunction with other laboratory tests, not on software functionality as the primary or sole component.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states that the devices are "quantitative in vitro assays" performed on a laboratory instrument (Siemens BN II nephelometer) for the measurement of specific substances (IgA Kappa and IgA Lambda) in a biological sample (serum). This is a core characteristic of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Purpose: The assays are used for "monitoring previously diagnosed IgA multiple myeloma" and are used "in conjunction with other laboratory tests and clinical evaluations." This clearly indicates a medical purpose related to patient health and management, which is the purpose of IVDs.
The lack of information in other sections like Device Description, Performance Studies, etc., does not negate the fact that the Intended Use/Indications for Use clearly define it as an in vitro diagnostic assay.
N/A
Intended Use / Indications for Use
Hevylite Human IgA Kappa is a quantitative in vitro assay performed on the Siemens BN II nephelometer 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 JgA Kappa / IgA I levylite I luman IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple mycloma and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunotixation. bone marrow and urine assessments.
Hevylite Human IgA Lambda is a quantiative in vitro assy performed on the Siemens IN II nepheloment of IgA Lambda (IgA heavy chain and Lambda light chain intact immunoglobulin) in scrum. Mcasurement of Hevylite Human IgA Lambda is used alongside Hevylite Human IgA Kappa to calculate the IgA Lamburratio. The Hevylite Human IgA Kappa / 12A Lambda ratio can be used when monitoring previously diagnosed lgA multiple mycloma 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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Scrvice
Food and Drug Administration 10903 New Humashite Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2014
THE BINDING SITE GROUP, LTD. Č/O MR. PAUL KĖNNY HEAD OF REGULATORY AFFAIRS 8 CALTHORPE RD, EDGBASTON BIRMINGHAM, WEST MIDLANDS, B15 IQT UNITED KINGDOM
Re: K140105
Trade/Device Name: Hevylite™ Human IgA Kappa Kit for use on Siemens BN™ II Systems and Hevylite™ Human IgA Lambda Kit for use on Siemens BNTM II Systems 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: January 13, 2014 Received: January 15, 2014
Dear Mr. Kenny:
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. Iisting 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 Part 801); medical device reporting (reporting of medical
1
Page 2 - Mr. Paul Kenny
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Maria M. Chan -S
Maria M. Chan, Ph.D. 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 Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
Indications for Use
510(k) Number (if known)
Device Name
Hevylite Human IgA Kappa Kit for use on Siemens BNII and Hevylite Human IgA Lambda Kit for use on Sicmens BNII
Indications for Use (Describe)
Hevylite Human IgA Kappa is a quantitative in vitro assay performed on the Siemens BN II nephelometer 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 JgA Kappa / IgA I levylite I luman IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple mycloma and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunotixation. bone marrow and urine assessments.
Hevylite Human IgA Lambda is a quantiative in vitro assy performed on the Siemens IN II nepheloment of IgA Lambda (IgA heavy chain and Lambda light chain intact immunoglobulin) in scrum. Mcasurement of Hevylite Human IgA Lambda is used alongside Hevylite Human IgA Kappa to calculate the IgA Lamburratio. The Hevylite Human IgA Kappa / 12A Lambda ratio can be used when monitoring previously diagnosed lgA multiple mycloma 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/2/Picture/15 description: The image shows the text "Maria MDC Chan -S". The text is written in a bold, sans-serif font. The letters "MDC" are stylized with a decorative pattern. The text is black against a white background.
FORM FDA 3881 (1/14)