(253 days)
This microwell enzyme-linked immunoabsorbant assay (ELISA) detection kit (C. difficile Toxin A+B ELISA Kit) is an in vitro diagnostic (IVD) immunoassay intended for use as an aid in the diagnosis of C. difficile associated disease. The kit detects C. difficile toxin A and B in human feces using peroxidase as the indicator enzyme. The assay may be read visually or with an ELISA reader. This IVD C. difficile Toxin A+B ELISA Kit is intended to be used with human stools that are fresh, frozen or in Cary Blair transport media in a clinical laboratory use setting. The kit may also be used with IVD Research's Quick'N'Easy fecal dilution device.
C. difficile Toxin A+B Fecal Antigen Detection Microwell ELISA
The provided text is a 510(k) premarket notification letter from the FDA to IVD Research Inc. for their C. difficile Toxin A+B Fecal Antigen Detection Microwell ELISA. It primarily concerns the FDA's determination of substantial equivalence and does not contain detailed information about the acceptance criteria, study design, or performance metrics of the device as requested. The document confirms that the device is cleared for marketing but does not provide the underlying study data to support that clearance.
Therefore, I cannot extract the requested information from the provided text.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized abstract design of an eagle or bird-like figure with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 27 2004
Mr. Dave Lambillotte President IVD Research Inc. 5909 Sea Lion Place, Suite D Carlsbad, CA 92008
Re: K032897
Trade/Device Name: C. difficile Toxin A+B Fecal Antigen Detection Microwell ELISA Regulation Number: 21 CFR 866.2660 Regulation Name: Microorganism Differentiation and Identification Device Regulatory Class: Class I Product Code: LLH Dated: April 19, 2004 Received: April 20p, 2004
Dear Mr. Lambillotte:
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 Fedcral 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 dctermination 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).
{1}------------------------------------------------
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms loter will and will you we cegal finding of substantial equivalence of your device to a legally prematicated predicated. "The 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, If you desire op 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). You may obtain other general information on your responsibilities under the Act from the I va may 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,
Salgado
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): ____K032897
Device Name: __ C. difficile Toxin A+B Fecal Antigen Detection Microwell ELISA
Indications For Use:
This microwell enzyme-linked immunoabsorbant assay (ELISA) detection kit (C. difficile Toxin A+B ELISA Kit) is an in vitro diagnostic (IVD) immunoassay intended for use as an aid in the diagnosis of C. difficile associated disease. The kit detects C. difficile toxin A and B in human feces using peroxidase as the indicator enzyme. The assay may be read visually or with an ELISA reader. This IVD C. difficile Toxin A+B ELISA Kit is intended to be used with human stools that are fresh, frozen or in Cary Blair transport media in a clinical laboratory use setting. The kit may also be used with IVD Research's Quick'N'Easy fecal dilution device.
Prescription Use X (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)
Kuddite Poole
Page 1 of 1
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032897
§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.