IVD CRYPTO/GIARDIA DFA

{0}------------------------------------------------ K0241113 ## 510(k) Summary of Safety and Effectiveness ## for MAR 0 5 2003 ## IVD Research, Inc.'s Cryptosporidium/Giardia Direct Fluorescent Antigen (DFA) Detection Kit | Submitter: | IVD Research Inc. | | | |------------|------------------------------|--------------------------------------|--| | | 5909 Sea Lion Place, Suite D | | | | | Carlsbad, CA 92008 USA | | | | | Tel: 760-929-7744 | Contact: Dave Lambillotte, President | | | Prepared: | 8 January 2003 | | | Common name: Cryptosporidium/Giardia Direct Fluorescent Antigen Detection Kit Proprietary name: IVD Research's Cryptosporidium/Giardia Direct Fluorescent Antigen Detection Kit Classification name: Entamoeba histolytica serological reagents Predicate Device: Meridian Diagnostic's Merifiuor ™ Cryptosporidium/Giardia Direct Fluorescent Antigen Detection Kit, 510(k) K912408 ### DESCRIPTION AND PRINCIPLE: This IVD Research, Inc. Cryptosporidium/Giardia Direct Fluorescent Antigen Detection Kit (DFA Assay) is intended for use as an in vitro diagnostic (IVD) fluorescent immunoassay for the qualitative determination of Cryptosporidium oocysts and Giardia cysts in stool feces. This assay may be used with stool samples that are preserved in 10% formalin, SAF, or Medical Chemical Corporation's (MCC's) Universal Fixative. This DFA Assay corresponds to FDA Classification Name: Entamoeba Histolytica Serological Reagent, a class II (non-exempt) Device, within the Microbiology Classification Panel, having FDA Reg. Citation Number: 21 CFR 866.3220, and FDA Product Codes: MHI and MHJ, and, as such, utilizes the principle of direct immunofluorescence microscopy. The conjugate contains a mixture of FITC-labeled monoclonal antibodies (derived from hybridized mouse B-cells) directed against Cryptosporidium oocysts and Giardia cysts, which, if present, are affixed to a treated slide (provided). The slide with sample material is then rinsed with wash solution to remove unbound conjugate and debris, and air-dried. The prepared slide is then examined using a fluorescent microscope, looking for an apple-green color and the characteristic morphology of the Cryptosporidium oocysts and the Giardia cysts. ### SUBSTANTIAL EQUIVALENCE COMPARISON This DFA Assay in vitro diagnostic (IVD) kit utilizes a principle of direct immunofluorescence. Conjugate solution within this kit contains a mixture of FITC-labeled mouse-derived monoclonal antibodies antigenically directed against Cryptosporidium oocysts and Giardia Cysts, which, if present, are affixed to a provided slide. The slide is then rinsed to remove unbound conjugate i/9/03 {1}------------------------------------------------ and examined under a fluorescent microscope looking for an apple-green color and the characteristic morphology of the Cryptosporidium oocysts and the Giardia cysts. The visual microscopic finding of qlowing oocysts or cysts with the correct morphology indicates the positive presence of Cryptosporidium or Giardia. A similar DFA kit is manufactured by Meridian Diagnostics (Cincinnati, OH). The FDA cleared this assay under 510(k) K912408 in 24 July 1991. This current DFA Assay uses the same methodology as that cleared predicate assay. The following is the data that shows this IVD DFA Assay provides substantial equivalence to the gold standard for parasitology (O&P microscopy) as well as the predicate device. The 95% Confidence Interval (CI) for this DFA Assay was determined using a Confidence Interval Analysis Microcomputer Program published by the British Medical Journal. Unless otherwise indicated, all fecal samples are derived from humans. The "form" of the fecal sample (i.e. formed, soft, liquid, etc.) is not significant to the diagnosis of parasitic infections. Cryptosporidium and Giardia can be present regardless of the sample form. #### Study #1 A total of 170 unconcentrated stools (145 human stools and 25 bovine stools) examined by O&P microscopy were tested against this IVD DFA Assay. The following results were obtained. | | Micro + | Micro - | |-------|---------|---------| | DFA + | 46 | 0 | | DFA - | 0 | 124 | For Giardia: Sensitivity: 100% (46/46) Specificity: 100% (124/124) 95% Cl = 92% to 100% 95% CI = 97% to 100% | | Micro + | Micro - | |-------|---------|---------| | DFA + | 39 | 0 | | DFA - | 0 | 131 | | For Cryptosporidium: | | |-----------------------------|----------------------| | Sensitivity: 100% (39/39) | 95% CI = 91% to 100% | | Specificity: 100% (131/131) | 95% CI = 97% to 100% | #### Study #2 A total of 53 unconcentrated stools examined by O&P microscopy were tested against this IVD DFA Assay. The following results were obtained. | | Micro + | Micro - | |-------|---------|---------| | DFA + | 16 | 0 | | DFA - | 0 | 37 | 1/9/03 {2}------------------------------------------------ For Giardia: Sensitivity: 100% (16/16) Specificity: 100% (37/37) 95% CI = 79% to 100% 95% Cl = 90% to 100% | | Micro + | Micro - | |-------|---------|---------| | DFA + | 11 | 0 | | DFA - | 0 | 42 | For Cryptosporidium: Sensitivity: 100% (11/11) Specificity: 100% (42/42) 95% Cl = 72% to 100% 95% Cl = 92% to 100% #### Study #3 A total of 74 formalin and SAF preserved stools were tested against this IVD DFA Assay. The following results were obtained. | | Micro + | Micro - | |-------|---------|---------| | DFA + | 26 | 0 | | DFA - | 0 | 48 | For Giardia: Sensitivity: 100% (26/26) Specificity: 100% (48/48) 95% CI = 87% to 100% 95% CI = 93% to 100% | | Micro + | Micro - | |-------|---------|---------| | DFA + | 18 | 0 | | DFA - | 1 | 55 | For Cryptosporidium: Sensitivity: 95% (18/19) Specificity: 100% (55/55) 95% Cl = 74% to 100% 95% CI = 94% to 100% #### Study #4 A total of 69 formalin and SAF preserved stools were tested in the predicate device and the IVD DFA Assay. There was 100% correlation between the two assays. No cross-reactions were seen with this DFA Assay for the following organisms: Entamoeba hartmanni, Endolimax nana, Entamoeba histolytica/dispar, Entamoeba coli, Blastocystis hominis, Dientamoeba fragilis, Chilomastix mesnili, Strongyloides steroralis, Ascars lumbricoides, Enterobius vermicularis, Diphyllobothrium species, Hymenolepis nana, Enteromonas hominis, Trichura, Iodamoeba buetschii, Hookworm, Taenia eggs, White Blood Cells, Cyclospora cayetanensis. {3}------------------------------------------------ ## ANALYTICAL SENSITIVITY This DFA Assay is capable of detecting 1 oocyst or cyst per 10 ul of unconcentrated sample. ## CONCLUSION IVD Research's Cryptosporidium/Giardia Direct Fluorescent Antigen Detection Kit uses similar methodology to the predicate device. In testing of various fecal specimens, the assay also showed equivalent sensitivity and specificity to the predicate device. Sincerely, Dave Lambillotte /9/D3 {4}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are abstract and created with thick, curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 IVD Research, Inc. c/o Alfredo J. Quattrone, Ph.D., D.A.B.T. Third Party 510(k) Review Coordinator Medical Device Safety Section Food and Drug Branch, MS-357, DHS Department of Health Services 601 North 7th Street, P.O. Box 942732, MS-357 Sacramento, CA 94234-7320 MAR - 5 2003 Re: k024113 Trade/Device Name: Cryptosporidium/Giardia Human Fecal Direct Fluorescent Antigen (DFA) Detection Kit Regulation Number: 21 CFR 866.3220 Regulation Name: Entamoeba Histolytica Serological Reagents Regulatory Class: Class II Product Code: MHI, MHJ Dated: February 6, 2003 Received: February 7, 2003 Dear Dr. Quattrone: 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {5}------------------------------------------------ ### Page 2 - This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Sutman Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # INDICATIONS FOR USE STATEMENT | 510(k) Number: | K024113 | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Cryptosporidium/Giardia Human Fecal Direct<br>Fluorescent Antigen (DFA) Detection Kit | | Indications for Use: | This direct fluorescent antigen (DFA) detection kit is<br>an in vitro diagnostic (IVD) immunoassay for the<br>detection of Cryptosporidium oocysts and Giardia<br>Cysts in human feces using fluorescent microscopic<br>visualization. This IVD assay is intended to be used<br>with stools preserved in 10% formalin, SAF or Medical<br>Chemical Corporation's (MCC's) Universal fixative.<br>Such samples may be concentrated or<br>unconcentrated. | Concurrence of CDRH, Office of Device Evaluation (ODE) Sally J. Silezak fr. F. Poole (Division (Division of Clinical Labor 510(k) Number Prescription Use (Per 21 CFR 801.109) Over-the Counter Use__________________________________________________________________________________________________________________________________________________________