MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY

K982709 · Alexon - Trend, Inc. · MHJ · Sep 3, 1998 · Microbiology

Device Facts

• Record ID: K982709
• Device Name: MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY
• Applicant: Alexon - Trend, Inc.
• Product Code: MHJ · Microbiology
• Decision Date: Sep 3, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3220
• Device Class: Class 2

Indications for Use

ProSpecT® Cryptosporidium Microplate Assay uses monoclonal antibodies for the qualitative detection of Cryptosporidium Specific Antigen (CSA) in aqueous extracts of fecal specimens.

Device Story

ProSpecT® Cryptosporidium Microplate Assay is an in vitro diagnostic test used in clinical laboratories. It utilizes monoclonal antibodies to detect Cryptosporidium Specific Antigen (CSA) in fecal specimens. The assay follows a microplate-based format where the presence of the antigen is determined qualitatively. Laboratory technicians perform the test; results are interpreted by healthcare providers to assist in diagnosing Cryptosporidium infections. The device provides a diagnostic aid for patients presenting with gastrointestinal symptoms.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Microplate-based enzyme immunoassay (EIA) utilizing monoclonal antibodies for antigen detection. In vitro diagnostic device.

Indications for Use

Indicated for the qualitative detection of Cryptosporidium Specific Antigen (CSA) in aqueous extracts of human fecal specimens to aid in the diagnosis of Cryptosporidium infection.

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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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 3 1998

Ken Hood Director of Regulatory Affairs Alexon - Trend 14000 Unity Street N.W. Ramsey, MN 55303-9115

Re: K982709

> Trade Name: ProSpecT® Cryptosporidium Microplate Assay Regulatory Class: II Product Code: MHJ Dated: August 4, 1998 Received: August 4, 1998

Dear Mr. Hood:

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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (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 [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely vours.

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: _ K 98 27 09

DEVICE NAME: ProSpecT® Cryptosporidium Microplate Assay

## INDICATIONS FOR USE:

:

ProSpecT® Cryptosporidium Microplate Assay uses monoclonal antibodies for the qualitative detection of Cryptosporidium Specific Antigen (CSA) in aqueous extracts of fecal specimens.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-------------------------------------------------|
| | Woodes Dubars |
| | (Division Sign-Off) |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K 982709 |
| Prescription Use<br>Per 21 CFR 801.109 | |
| | OR |
| | Over-The-Counter-Use<br>(Optional Format 1-2-96 |