(522 days)
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No
The summary describes an in vitro diagnostic kit for quantifying protein concentrations using a nephelometer, which is a standard laboratory technique. 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 diagnostic (IVD) test for quantifying IgA Kappa and IgA Lambda in human serum, intended for monitoring previously diagnosed IgA multiple myeloma, not for treating a disease.
Yes
The device is intended for "in vitro quantification" of IgA Kappa and IgA Lambda in human serum and "the test result is to be used with previously diagnosed IgA multiple myeloma, in conjunction with other clinical and laboratory findings," which clearly indicates its use in aiding diagnosis or monitoring a disease state.
No
The device is described as an "in vitro quantification kit" intended for use with a "Siemens Behring Nephelometer™ II (BN™ II)". This strongly indicates a physical kit containing reagents and potentially other consumables, used in conjunction with a hardware instrument (the nephelometer), which are not software-only components.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "This kit is intended for the in vitro quantification..."
- "The test result is to be used with previously diagnosed IgA multiple myeloma, in conjunction with other clinical and laboratory findings."
These phrases clearly indicate that the device is designed to be used outside of the body (in vitro) to analyze human samples (serum) and provide information that aids in diagnosis or monitoring, which is the definition of an IVD.
N/A
Intended Use / Indications for Use
This kit is intended for the in vitro quantification of IgA Kappa (combined a 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 IgA multiple myeloma, in conjunction with other clinical and laboratory findings.
This kit is intended for the in vitro quantification of IgA Lambda (combined a 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 IgA multiple myeloma, in conjunction with other clinical and laboratory findings.
Product codes (comma separated list FDA assigned to the subject device)
CFN, 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
Prescription Use
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a series of flowing lines. The symbol is black, and the text is also in black.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
The Binding Site Group Ltd. c/o Mr. Jay H. Geller Authorized U.S. Representative 12100 Wilshire Boulevard, Suite 500 Los Angeles, CA 90025-7121
MAR 0 1 2010
Re: K082823
Trade/Device Name: Hevylite™ Human IgA Kappa Kit for use on the Siemens BN™ II Hevylite™ Human IgA Lambda Kit for use on the Siemens BNTM II Regulation Number: 21 CFR § 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E Immunological Test System Regulatory Class: Class II Product Code: CFN. OPX. OPY Dated: January 18, 2010 Received: January 27, 2010
Dear Mr. Geller:
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. Drue, 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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
1
Page 2 – Mr. Jay H. Geller
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 medical device-related adverse events),(21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/ReportalProblem/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/cdrh/industry/support/index.html.
Sincerely vours,
ia m chen
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K082823
Device Name: Hevylite™ Human IgA Kappa Kit for use on Siemens BN™II Systems
Indications for Use: This kit is intended for the in vitro quantification of IgA Kappa (combined a 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 IgA multiple myeloma, in conjunction with other clinical and laboratory findings.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD).
Deena Philip
Division Sign-Off
Office of In Vitro Diaanostic Device Evaluation and Safety
510(k) 082823
Page 1 of 1
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Indications for Use
510(k) Number (if known): K082823
Device Name: Hevylite™ Human IgA Lambda Kit for use on Siemens BN™II Systems
Indications for Use: This kit is intended for the in vitro quantification of IgA Lambda (combined a 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 IgA multiple myeloma, in conjunction with other clinical and laboratory findings.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD).
Page 1 of 1
Reena Philip
Division Sign-Off
510(k) 082823
Office of In Vitro Diagnostic Device Evaluation and Safety