(105 days)
Alexon ProSpecT
Standard microscopic examination
No
The summary describes a standard immunochromatographic assay for antigen detection, with no mention of AI, ML, image processing, or any computational analysis beyond basic performance metrics.
No
This device is an in vitro diagnostic assay used for qualitative detection of antigens, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" states "immunochromatographic assay for the simultaneous qualitative detection and distinguishing of Giardia and Cryptosporidium specific antigens in aqueous extracts of fecal specimens" and "For In Vitro Diagnostic Use." This clearly indicates its purpose is to diagnose diseases caused by Giardia and Cryptosporidium by detecting specific antigens.
No
The device is described as an "immunochromatographic assay" and an "Immunoassay," which are laboratory tests involving physical reagents and materials, not solely software. The performance studies also describe testing of physical specimens.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use."
- Intended Use: The device is designed to detect specific antigens in fecal specimens, which are biological samples taken from the body. This is a hallmark of in vitro diagnostics.
- Care Setting: It is intended for "professional laboratory use," which is a common setting for IVD testing.
- Performance Studies: The document includes performance studies (sensitivity, specificity, agreement) comparing the device to a reference method and a predicate device, which are standard requirements for demonstrating the performance of an IVD.
N/A
Intended Use / 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.
Product codes
MHI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional laboratory use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Comparative performance study: A Comparative performance study was conducted using the Genzyme GiardialCryptosporidium Assay, a Reference method (microscopic examination) and predicate method (Alexon ProSpecT).
Retrospective Analysis Genzyme vs Microscopic examination
Giardia: Sensitivity = 33/33 = 100%, Specificity = 109/109 = 100%
Cryptosporidium: Sensitivity = 36/37 = 97.3%, Specificity = 105/105 = 100%
Prospective Analysis Genzyme vs Microscopic examination
Giardia: Sensitivity = 50/50 = 100%, Specificity = 448/452 = 99.1%
Cryptosporidium: Sensitivity = 73/73 = 100%, Specificity = 427/429 = 99.5%
Retrospective Analysis Genzyme vs Rapid EIA
Giardia: Relative Agreement = 138/142 = 97.2%
Cryptosporidium: Relative Agreement = 142/142 = 100%
The Genzyme method yielded acceptable relative agreement with the predicate method.
Agreement studies: 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.
Key Metrics
Sensitivity, Specificity, Relative Agreement
Predicate Device(s)
Alexon ProSpecT
Reference Device(s)
Standard microscopic examination
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 | |
| Medix Biotech subsidiary | ||
| 1531 Industrial Road | ||
| San Carlos, CA 94070 | ||
| Contact Person: | Barbara Pizza, Manager Regulatory Affairs, (617) 252-7953 | |
| Genzyme Diagnostics | ||
| One Kendall Square, Building 200 | ||
| 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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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health and Human Services.
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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Page 2
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 (770)488-7655.
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" (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 (800) 638-2041 or at (301) 443-6597 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