(42 days)
This kit is intended for quantifying IgG subclasses 1, 2, 3 and 4 immunoglobulins in serum on the BNII. Measurement of these immunoglobulins aids in the diagnosis of abnormal immunoglobulin production and the body's lack of ability to resist infectious agents.
Human IgG Subclass Liquid Reagent Kits (for use on the Behring BNII Analyser)
I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The text is a letter from the FDA regarding a 510(k) premarket notification for "Human IgG Subclass Liquid Reagent Kits," approving the device for marketing. It discusses regulatory information, classifications, and general controls, but it does not detail:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results (effect size with AI assistance).
- Standalone algorithm performance.
- Type of ground truth used (pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
The "Indications for Use Statement" mentions that the kit is for "quantifying IgG subclasses 1, 2, 3 and 4 immunoglobulins in serum," and that "Measurement of these immunoglobulins aids in the diagnosis of primary and secondary immunodeficiency diseases and the body's lack of ability to resist infectious agents." However, this is about the intended use, not the performance or validation study details.
{0}------------------------------------------------
Image /page/0/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 3 1 2001
The Binding Site, Limited c/o Mr. Jay H. Geller West Tower, Suite 4000 2425 West Olympic Boulevard Santa Monica, California 90404
Re: K012292
Trade Name: Human IgG Subclass Liquid Reagent Kits (for use on the Behring BNII Analyser) Regulation Number: 21 CFR § 866.5510 Regulatory Class: II Product Code: CFN Dated: July 19, 2001 Received: July 20, 2001
Dear Mr. Geller:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{1}------------------------------------------------
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonticate 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 Part 801 and 11 you desire specific devices), please contact the Office of Compliance at additionally 00911 v 101 - 10 questions on the promotion and advertising of your device, (201) 59 mtact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mornation on your rouper Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
INDICATIONS FOR USE STATEMENT
Human IgG Subclass Liquid Reagent Kits (for use on Device Name: Device Name. - Tiamana (Product Code LK001.TB)
This kit is intended for quantifying IgG Indications for Use: subclasses 1, 2, 3 and 4 immunoglobulins in serm on the BNIT. Subcrasses if 2, 3 and minunoglobulins aids in the diagnosis of Measurement Of Chese Imanogrobailial and the body's lack of ability to resist infectious agents.
Donald
Site
(Division Sign-Off)/
Division of Clinical Laboratory Devices
510(k) Number_1012292
ATTACHMENT 16
§ 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).