(208 days)
This ELISA is an in vitro immunoassay for the qualitative determination of Giardia antigen in feces.
It is a double antibody (sandwich) ELISA using an anti-Giardia antibody to capture the antigen from the stool supernatant. A second antibody is then added which sandwiches the captured antigen. This reaction is visualized by the addition of an anti-second antibody conjugated to peroxidase and the chromogen tetramethylbenzidine (TMB). The resulting blue color development indicates the presence of Giardia antigens being bound by the anti-Giardia antibodies.
This document is an FDA 510(k) clearance letter for the Giardia Antigen Detection Microwell ELISA Assay. It does not contain information about acceptance criteria, device performance, sample sizes for testing/training, ground truth establishment, or human reader effectiveness studies.
The provided text is purely an FDA clearance letter and an "Indication For Use" statement. It does not include a study description with the requested details. Therefore, I cannot extract the information to complete the table or answer the questions.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
098 Gaither Boad Rockville MD 20850
Mr. Dave Lambillotte President IVD Research Inc. 5909 Sea Lion Place, Suite D Carlsbad, CA 92008
Re: K020583
Trade/Device Name: Giardia Antigen Detection Microwell ELISA Assay Regulation Number: 21 CFR 866.3220 Regulation Name: Entamoeba histolytica serological reagents Regulatory Class: Class II Product Code: MHI Dated: August 19, 2002 Received: August 26, 2002
Dear Mr. Lambillotte:
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/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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IVD Research, Inc.
5909 Sea Lion Place, Suite D Carlsbad, CA 92008 USA
760 929-7744 Tel: 760 431-7759 Fax:
Statement of Indications For Use
Intended Use
This ELISA is an in vitro immunoassay for the qualitative determination of Giardia antigen in feces. It is a double antibody (sandwich) ELISA using an anti-Giardia antibody to capture the antigen from the stool supernatant. A second antibody is then added which sandwiches the captured antigen. This reaction is visualized by the addition of an anti-second antibody conjugated to peroxidase and the chromogen tetramethylbenzidine (TMB). The resulting blue color development indicates the presence of Giardia antigens being bound by the anti-Giardia antibodies.
Freddie th. Poole
Division Sign-O (Wision of Clinical Laboratory Devices
510(k) Number K020583
Prescription device <---
§ 866.3220
Entamoeba histolytica serological reagents.(a)
Identification. Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toEntamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyEntamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasiteEntamoeba histolytica and provides epidemiological information on diseases caused by this parasite. The parasite may invade the skin, liver, intestines, lungs, and diaphragm, causing disease conditions such as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.