(20 days)
This range of kits is intended for quantifying IgG Subclasses 1, 2, 3 & 4 immunoglobulins in serum on the Beckman Immage Analyzer.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The document is an FDA 510(k) premarket notification letter for a device called "Human IgG Subclass Kit for Use on the Beckman Immage Analyser." It states that the device is substantially equivalent to a legally marketed predicate device.
The information primarily concerns regulatory approval, product codes, regulation numbers, and contact information for the FDA. It does not contain the technical details of a study or acceptance criteria as requested in your prompt.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 16 2002
The Binding Site, Limited c/o Mr. Jay H. Geller West Tower. Suite 4000 2425 West Olympic Boulevard Santa Monica. California 90404
Re: K022083
Trade/Device Name: Human IgG Subclass Kit for Use on the Beckman Immage Analyser Regulation Number: 21 CFR § 866.5510 Regulation Name: Immunoglobulins A. G. M. D and E Immunological Test System Regulatory Class: II Product Code: CFN Dated: June 24, 2002 Received: June 26, 2002
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Steven Sutman
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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Page_____of___________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): _ KOAL 083_
Human IgG Subclass Kit for Use on The Beckman Immage Device Name: Analyser
This range of kits is intended for Indications for Use: quantifying IgG Subclasses 1, 2, 3 & 4 immunoglobulins in serum on the Beckman Immage Analyzer.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
J. Reeves for S. Altes
(Division Sign-Off) Division of Clinical Laboratory Devices 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).