(16 days)
The CRYPTOSPORIDIUM II test is an enzyme immunoassay for the qualitative detection of Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Cryptosporidium gastrointestinal infection. FOR IN VITRO DIAGNOSTIC USE.
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The provided text is a 510(k) premarket notification letter from the FDA, granting market clearance for the "CRYPTOSPORIDIUM II" device. It outlines the device's indications for use and states that it has been deemed substantially equivalent to a legally marketed predicate device.
However, the provided text does not contain the detailed study information required to answer your specific questions regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies. This type of information is typically found in the 510(k) summary or the actual study reports submitted to the FDA, not in the clearance letter itself.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device we have 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 (the Act) that do not require approval of a premarket approval application (PMA)." This indicates that the device was cleared based on substantial equivalence, not necessarily on a de novo study proving it meets specific acceptance criteria with detailed performance metrics in the way you've outlined for an AI/imaging device.
Therefore, I cannot populate the table or answer the subsequent questions based solely on the provided text. To get this information, you would need to access the full 510(k) submission for K052932, which might be publicly available through FDA databases or by request.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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NOV - 4 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
David M. Lyerly, Ph.D. Vice President, Research and Development TechLab® Inc. 2001 Kraft Drive Blacksburg, Virginia 24060-6358
K052932 Re:
Trade/Device Name: CRYPTOSPORIDIUM II Regulation Number: 21 CFR § 866.3220 Regulation Name: Entamoeba Histolytica Serological Reagents Regulatory Class: II Product Code: MHJ Dated: October 18, 2005 Received: October 19, 2005
Dear Dr. Lyerly:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & nove 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 for ass sured in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered pror to rial 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de nees may nave been require approval of a premarket approval application (PMA). and Costietle Fee (110) that to novice, subject to the general controls provisions of the Act. The 1 ou may, ateretory, mails 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 rr your device to such additional controls. Existing major regulations affecting your device can may be subject to basil add 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 r 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 or any I 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).
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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 (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html
Sincerely yours.
Sally a Horn
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Not known
K 052932
Device Name: CRYPTOSPORIDIUM II
Indications For Use:
The CRYPTOSPORIDIUM II test is an enzyme immunoassay for the qualitative detection of Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Cryptosporidium gastrointestinal infection.
FOR IN VITRO DIAGNOSTIC USE.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Ludella Poole
Division Sign-Off
Page 1 of
Office of In Vitro Diagnostic Device Evaluation and Safety
K05293L $10(k)________________________________________________________________________________________________________________________________________________________________________
§ 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.