(456 days)
Hevylite™ Human IgM Kappa Kit for use on Siemens BN™II is intended for the in vitro quantification of IgM Kappa (combined u heavy and K light chain) concentration in human serum on the Siemens Behring Nephelometer™ II (BN™ II). The test result is to be used with previously diagnosed Waldenstoms Macrolobulinaemiain conjunction with other clinical and laboratory findings. This assay has not been established for the diagnosis, monitoring and prognosis of Waldenstroms macroglbulinaemia.
Hevylite™ Human IgM Lambda Kit for use on Siemens BN™II is intended for the in vitro quantification of IgM Lambda (combined u heavy and À light chain) concentration in human serum on the Siemens Behring Nephelometer™ II (BN™ II). The test result is to be used with previously diagnosed Waldenstoms Macrolobulinaemia in conjunction with other clinical and laboratory findings. This assay has not been established for the diagnosis, monitoring and prognosis of Waldenstroms macrogibulinaemia.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for an IVD (In Vitro Diagnostic) device. It does not describe a study that uses AI or involves human readers, nor does it provide acceptance criteria and performance data in the structured format requested. Instead, it confirms the substantial equivalence of the "Hevylite™ Human IgM Kappa Kit" and "Hevylite™ Human IgM Lambda Kit" to legally marketed predicate devices.
The document focuses on:
- Device Name: Hevylite™ Human IgM Kappa Kit and Hevylite™ Human IgM Lambda Kit for use on Siemens BN™ II Systems.
- Intended Use: In vitro quantification of IgM Kappa and IgM Lambda concentrations in human serum using the Siemens Behring Nephelometer™ II (BN™ II). These results are to be used with previously diagnosed Waldenstroms Macroglobulinemia, in conjunction with other clinical and laboratory findings.
- Limitation: The assay has not been established for the diagnosis, monitoring, and prognosis of Waldenstroms Macroglobulinemia.
- Regulatory Information: Regulation number, name, class, product code, and a statement of substantial equivalence to predicate devices.
Therefore, it is not possible to extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document, as it pertains to an IVD device approval and not an AI/ML-based diagnostic study.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 27, 2013
The Binding Site Group, Ltd. c/o Dr. Jill Constatine, Regulatory Affairs Scientist 8 Calthorpe Road Edgbaston, Birmingham West Midlands UK B15 10T
Re: K113823
Trade/Device Name: Hevylite™ Human IgM Kappa Kit for use on Siemens BN™ II Systems Hevylite™ Human IgM 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
Regulation Name: Immunoglobulins A.
Regulatory Class: Class II
Product Code: CFN. PDE. PDF
Dated: March 26, 2013
Received: March 26, 2013
Dear Dr. Constantine:
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 misJeading.
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.
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Page 2 - Dr. Jill Constantine
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
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
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Indications for Use
510(k) Number (if known): K113823
Device Name:
Hevylite™ Human IgM Kappa Kit for use on Siemens BN™ II Hevylite™ Human IgM Lambda Kit for use on Siemens BN™ II
Indications For Use:
Hevylite Human IgM Kappa Kit for use on Siemens BN™II is intended for the in vitro quantification of IgM Kappa (combined u heavy and K light chain) concentration in human serum on the Siemens Behring Nephelometer™ II (BN™ II). The test result is to be used with previously diagnosed Waldenstoms Macrolobulinaemiain conjunction with other clinical and laboratory findings.
This assay has not been established for the diagnosis, monitoring and prognosis of Waldenstroms macroglbulinaemia.
Hevylite Human IgM Lambda Kit for use on Siemens BN™II is intended for the in vitro quantification of IgM Lambda (combined u heavy and À light chain) concentration in human serum on the Siemens Behring Nephelometer™ II (BN™ II). The test result is to be used with previously diagnosed Waldenstoms Macrolobulinaemia in conjunction with other clinical and laboratory findings.
This assay has not been established for the diagnosis, monitoring and prognosis of Waldenstroms macrogibulinaemia.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Maria Maria Maria - S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K113823
§ 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).