(186 days)
This kit is intended for quantifying human IgA subclasses 1 and 2 in serum on the BNII. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Not Found
I apologize, but the provided text from the FDA 510(k) letter for the "Human IgA Subclass BNII Combi Kit" (K981912) does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
This document is a letter from the FDA indicating substantial equivalence for a medical device, which means the device is deemed as safe and effective as a legally marketed predicate device. While it mentions the device's intended use and classification, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about the sample size, data provenance, number and qualifications of experts, adjudication method for a test set.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Specifics on the type of ground truth used, training set sample size, or how the training set's ground truth was established.
These types of details would typically be found in the original 510(k) submission document or supporting studies, which are not included in this letter. The letter itself is a regulatory approval notice, not a summary of the underlying performance studies.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 4 1998
The Binding Site, Ltd. C/O Jay H. Geller East Tower, Suite 600 2425 West Olympic Boulevard Santa Monica, CA 90404
Re: K981912 Trade Name: Human IgA Subclass BNII Combi Kit Requlatory Class: II Product Code: CFN October 2, 1998 Dated: Received: October 6, 1998
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.
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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 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Butman
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
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510(k) Number (if known): 11 981912-
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
INDICATIONS FOR USE STATEMENT
Human IgA Subclass BNII Combi Kit Device Name:
This kit is intended for quantifying human Indications for Use: IgA subclasses 1 and 2 in serum on the BNII. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
Artur E. Madson
(Division Sign-Off)
Division of Clinical Laboratory Devices K981912
510(k) Number
Prescription Use_V (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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).