(128 days)
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.
Not Found
This FDA 510(k) clearance letter pertains to the Hevylite™ Human IgG Kappa Kit and Hevylite™ Human IgG Lambda Kit for use on Siemens BN™ II Systems. It's important to note that this document is a regulatory approval and does not contain the specifics of a study proving the device meets acceptance criteria in the format you requested for AI/ML devices.
The information typically found in a clinical study report for an AI/ML device, such as sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies, is not present in this regulatory correspondence for an in vitro diagnostic test system.
However, I can extract information related to the device and its intended use, and general aspects of regulatory review for in vitro diagnostic kits.
General Information on this Device:
- Device Name: Hevylite™ Human IgG Kappa Kit and Hevylite™ Human IgG Lambda Kit
- System Used On: Siemens BN™ II nephelometer
- 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
- Indications for Use:
- Hevylite Human IgG Kappa: Quantitative in vitro assay for the measurement of IgG Kappa (IgG heavy chain and Kappa light chain intact immunoglobulin) in serum. Used alongside Hevylite Human IgG Lambda to calculate the IgG Kappa / IgG Lambda ratio. The ratio can be used when monitoring previously diagnosed IgG multiple myeloma and is used in conjunction with other laboratory tests and clinical evaluations.
- Hevylite Human IgG Lambda: Quantitative in vitro assay for the measurement of IgG Lambda (IgG heavy chain and Lambda light chain intact immunoglobulin) in serum. Used alongside Hevylite Human IgG Kappa to calculate the IgG Kappa / IgG Lambda ratio. The ratio can be used when monitoring previously diagnosed IgG multiple myeloma and is used in conjunction with other laboratory tests and clinical evaluations.
- Important Caveat: "The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments." This indicates the device is an aid in diagnosis/monitoring, not a standalone definitive test.
Why the requested information is not in this document:
This is a 510(k) clearance letter. For in vitro diagnostic devices like these, the "acceptance criteria" and "study proving the device meets acceptance criteria" are typically detailed in the technical documentation submitted by the manufacturer to the FDA. This documentation would include:
- Analytical Performance Studies: Demonstrating accuracy, precision, linearity, limit of detection, limit of quantitation, interference, calibration, etc. These would have specific acceptance criteria (e.g., %CV for precision, % recovery for accuracy) and study designs (e.g., number of replicates, number of samples).
- Clinical Performance Studies: Demonstrating how well the device performs in a clinical setting, often comparing its results to established methods or clinical outcomes. These studies would involve patient samples and typically assess aspects like sensitivity, specificity, positive predictive value, negative predictive value, and agreement with predicate devices or clinical endpoints.
The FDA reviews this submitted data and, if it finds the device "substantially equivalent" to a predicate device, issues this clearance letter. The letter itself is primarily the outcome of that review, not the detailed study results.
Therefore, the table and detailed information you requested about acceptance criteria and study particulars for an AI/ML device cannot be extracted directly from this specific document because:
- It is not an AI/ML device. It's an in vitro diagnostic immunoassay kit.
- This document is a clearance letter, not a study report. The detailed study data reviewed by the FDA is proprietary and part of the manufacturer's 510(k) submission, not typically published in the clearance letter.
To provide the information you're looking for, one would need access to the complete 510(k) submission document, which is not publicly available in detail, or peer-reviewed publications by the manufacturer discussing the performance studies.
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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
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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
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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
§ 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).