(128 days)
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No
The description focuses on a quantitative in vitro assay performed on a nephelometer, which is a standard laboratory technique for measuring protein concentrations. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
This device is an in vitro diagnostic assay used for quantitative measurement of specific immunoglobulins in serum to monitor previously diagnosed IgG multiple myeloma, which is a diagnostic purpose, not therapeutic.
No
The device is an in vitro assay used for measurement of specific immunoglobulins, which is used for monitoring previously diagnosed conditions and in conjunction with other tests, rather than for initial diagnosis.
No
The device is described as an "in vitro assay performed on the Siemens BN II nephelometer," indicating it is a laboratory test that utilizes a specific hardware instrument (the nephelometer) to measure analytes in serum. This is not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- "quantitative in vitro assay": This explicitly states that the device is an assay performed in vitro (outside of a living organism).
- "performed on the Siemens BN II nephelometer": This indicates a laboratory-based test using a specific instrument.
- "for the measurement of IgG Kappa... in serum": This specifies the analyte being measured and the biological sample type (serum).
- "Measurement of Hevylite Human IgG Kappa is used alongside Hevylite Human IgG Lambda to calculate the IgG Kappa / IgG Lambda ratio.": This describes how the results are used in a diagnostic context.
- "The Hevylite Human IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma": This clearly states the diagnostic purpose of the test – monitoring a specific disease.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
Hevylite Human IgG Kappa is a quantitative in vitro assay performed on the Siemens BN II nephelometer for the measurement of IgG Kappa (IgG heavy chain and Kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgG Kappa is used alongside Hevylite Human IgG Lambda to calculate the IgG Kappa / IgG Lambda ratio. The Hevylite Human IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma 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 IgG Lambda is a quantitative in vitro assay performed on the Siemens BN II nephelometer of IgG Lambda (IgG heavy chain and Lambda light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgG Lambda is used alongside Hevylite Human IgG Kappa / IgG Lambda ratio. The Hevylite Human IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma 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
PCN, PCO
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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of promoting health, well-being, and human services. The eagle is positioned to the right of a circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2013
THE BINDING SITE GROUP, LTD. C/O MR. PAUL KENNY HEAD OF REGULATORY AFFAIRS 8 CALTHORPE RD, EDGBASTON BIRMINGHAM, WEST MIDLANDS, B15 1QT UNITED KINGDOM
Re: K132555
Trade/Device Name: Hevylite™ Human IgG Kappa Kit for use on Siemens BN™ II Systems and Hevylite™ Human IgG Lambda Kit for use on Siemens BN™ 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: PCN, PCO Dated: November 12, 2013 Received: November 15, 2013
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, 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 Part 801); medical device 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 (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 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: December 31, 2013 See PRA Statement on fast page.
Indications for Use
510(k) Number (if known) K132555
Device Name
Hevylite Human IgG Kappa kit for use on the Siemens BN II and Hevylite Human IgO Lamboda kil for use on the Siemens BN II
Indications for Use (Describe)
Hevylite Human IgG Kappe is a quantitative in viro assay performed on the Siemens BN II nechelometer for the mesurenent of IgG Kappa (lgG heavy chain and Kappa light chain intert immunoglobulin) in serum. Measurement of Hevylite Human IgG Kappa is used alongside Hevylite Human IgG Lambda to calculate the IgG Kappa / IgG Lambda ratio. The Hevylice Human IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma and is used in conjunction with other Isporatory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.
Hevylite Human IgG Lambda is a quantiative in viro assey performed on the Siemens BN II nephelometer of IgG Lambda (IgO heavy chain and Lambde light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgG Lambda is used alongside Hevylite Human IgO Kappa I IgO Lambarratio. The Hevylite Human IgO Kappa / IgG Lambaratio can be used when monitoring previously diagnosed IgG multiple myeloma 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpant C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
CENTRE FERRENCE SERVET FOR FDA USE ONLY SEBREAK FOR FDA USE ONLY 1988 WE WAS DECEMBER 200 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Maria M. Chan -S
FORM FDA 3881 (9/13)
PSC Publishing Services (202) 448-4340 E