GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY

K983399 · Genzyme Diagnostics · MHI · Jan 11, 1999 · Microbiology

Device Facts

• Record ID: K983399
• Device Name: GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY
• Applicant: Genzyme Diagnostics
• Product Code: MHI · Microbiology
• Decision Date: Jan 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3220
• Device Class: Class 2

Indications for Use

This is an immunochromatographic assay for the simultaneous qualitative detection and distinguishing of Giardia and Cryptosporidium specific antigens in aqueous extracts of fecal specimens. It is intended for professional laboratory use. For In Vitro Diagnostic Use.

Device Story

The Contrast Giardia/Cryptosporidium Combo Rapid Assay is an immunochromatographic test used in clinical laboratories to detect and distinguish Giardia and Cryptosporidium antigens in fecal specimens. The device processes aqueous fecal extracts to provide qualitative results. It is operated by laboratory professionals to assist in the diagnosis of parasitic infections. The output is a visual result indicating the presence or absence of specific antigens, which aids clinicians in making diagnostic and treatment decisions for patients suspected of having these gastrointestinal pathogens.

Clinical Evidence

Performance evaluated via retrospective and prospective comparative studies against microscopic examination and the Alexon ProSpecT predicate. Retrospective analysis (n=142) showed 100% sensitivity and 100% specificity for Giardia, and 97.3% sensitivity and 100% specificity for Cryptosporidium vs. microscopy. Prospective analysis (n=525) showed 100% sensitivity and 99.1% specificity for Giardia, and 100% sensitivity and 99.5% specificity for Cryptosporidium vs. microscopy. Relative agreement with rapid EIA predicate was 97.2% for Giardia and 100% for Cryptosporidium. Precision studies (within-run and between-run) demonstrated 100% agreement.

Technological Characteristics

Immunochromatographic assay for qualitative antigen detection. Form factor is a rapid test format for aqueous fecal extracts. Operates via antibody-antigen binding principles. No electronic energy source or software algorithm required.

Indications for Use

Indicated for the simultaneous qualitative detection and differentiation of Giardia and Cryptosporidium antigens in aqueous fecal specimens in a professional laboratory setting.

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.

Predicate Devices

• Alexon ProSpecT

Submission Summary (Full Text)

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zyme Diagnostics/Medix Biotech subsidiary

1983399 Contrast® GiardialCryptosporidium Combo Rapid Assay Reference No. K983399

December 23, 1998

San Carlos, CA 94070

JAN 1 1 1999

Industrial Road

## CONFIDENTIAL

## ATTACHMENT 1

#### 510(k) Summary Of Safety and Effectiveness Information

| Trade or Proprietary Name: | Giardia/Cryptosporidium Combo Rapid Assay | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Common or Usual Name: | Immunoassay for Giardia and Cryptosporidium Antigens | |
| Manufacturer: | Genzyme Diagnostics<br>Medix Biotech subsidiary<br>1531 Industrial Road<br>San Carlos, CA 94070 | |
| Contact Person: | Barbara Pizza, Manager Regulatory Affairs, [phone]<br>Genzyme Diagnostics<br>One Kendall Square, Building 200<br>Cambridge, MA 02139-1562 | |

The use of the Genzyme Contrast@ Giardia/Cryptosporidium Combo Rapid Assay in the clinical laboratory setting is substantially equivalent to a currently marketed method for Giardia and Cryptosporidium for the detection of Giardia and Cryptosporidium antigen in aqueous fecal specimens.

#### PERFORMANCE STUDIES:

#### Comparative Performance Studies

A Comparative performance study was conducted using the Genzyme GiardialCryptosporidium Assay, a Reference method (microscopic examination) and predicate method (Alexon ProSpecT). The summary of the sensitivity and specificity are provided below.

| | Sensitivity | Specificity |
|-----------------------------------------------------------|---------------|--------------------|
| Retrospective Analysis Genzyme vs Microscopic examination | | |
| Giardia | 33/33 = 100% | 109/109 = 100% |
| Cryptosporidium | 36/37 = 97.3% | 105/105 = 100% |
| Prospective Analysis Genzyme vs Microscopic examination | | |
| Giardia | 50/50 = 100% | 448/452 = 99.1% |
| Cryptosporidium | 73/73 = 100% | 427/429 = 99.5% |
| Retrospective Analysis Genzyme vs Rapid EIA | | Relative Agreement |
| Giardia | | 138/142 = 97.2% |
| Cryptosporidium | | 142/142 = 100% |

The Genzyme method yielded acceptable relative agreement with the predicate method.

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## Agreement

Both within-run and between-run studies were performed using Giardia and Cryptosporidium positive and neqative stool specimens. Five replicates of each specimen stool pool (Giardia positive, Cryptosporidium positive and GiardialCryptosporidium negative) was tested five times in one batch using the Contrast Giardial Cryptosporidium Combo Rapid Assay over five days. The Agreement was calculated for each stool specifications for within and between-run precision were 100% agreement.

## Conclusion

Based on the results of the performance studies described above, the Genzyme Contrast Giardial Cryptosporidium Combo Rapid Assay is substantially equivalent in performance to the reference method (Standard microscopic examination) and to the predicate (Alexon ProSpecT) a legally marketed method for the detection of Giardia and Cryptosporidium antigen in aqueous fecal specimens.

In lieu of a 510(k) statement under 513(i) of the Act, this information is provided as a 510(k) summary for disclosure to any other persons/companies without the specific written authorization from Genzyme Corporation.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 1 1999

Barbara Pizza Manager, Regulatory Affairs Genzyme Diagnostics One Kendall Square Cambridge, MA 02139-1562

K983399 Re:

Trade Name: Contrast® Giardia/Cryptosporidium Combo Rapid Assay Regulatory Class: II Product Code: MHI Dated: December 23, 1998 Received: December 24, 1998

Dear Ms. Pizza:

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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 yours.

Steven Putman

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 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:4 Contrast® Giardia/Cryptosporidium Combo Rapid Assay

Indications For Use:

This is an immunochromatographic assay for the simultaneous qualitative detection and distinguishing of Giardia and Cryptosporidium specific antigens in aqueous extracts of fecal specimens.

It is intended for professional laboratory use.

For In Vitro Diagnostic Use.

Woody Dubois

vision of Clinical Laboratory Devices 510(k) Number.

PRESCRIPTION USE X