IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96

K020583 · Ivd Research, Inc. · MHI · Sep 17, 2002 · Microbiology

Device Facts

• Record ID: K020583
• Device Name: IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96
• Applicant: Ivd Research, Inc.
• Product Code: MHI · Microbiology
• Decision Date: Sep 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3220
• Device Class: Class 2

Indications for 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.

Device Story

Device is an in vitro diagnostic sandwich ELISA for qualitative detection of Giardia antigen in human stool samples. Process involves capturing antigen from stool supernatant using anti-Giardia antibodies; adding secondary antibody; visualizing via peroxidase-conjugated anti-secondary antibody and TMB chromogen. Blue color development indicates positive result. Used in clinical laboratory settings by trained technicians. Output is visual color change interpreted by laboratory personnel to assist in clinical diagnosis of Giardia infection.

Technological Characteristics

In vitro immunoassay; double antibody (sandwich) ELISA format. Reagents include anti-Giardia capture antibodies, secondary antibodies, peroxidase conjugate, and TMB chromogen. Manual or automated microwell plate processing. No electronic components or software algorithms.

Indications for Use

Indicated for the qualitative detection of Giardia antigen in human fecal specimens to aid in the diagnosis of Giardia infection. Prescription use only.

Regulatory Classification

Identification

Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Entamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Entamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasite Entamoeba 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.

Special Controls

*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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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: [phone] 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 <---