(91 days)
The QUANTA Lite™ H. pylori IgA kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgA antibodies to H. pylori (Helicobacter pylori) in human serum. This test is intended to aid in the diagnosis of H. pylori infection in adult patients 18 years or older with clinical signs and symptoms of gastrointestinal disease. The QUANTA Lite™ H. pylori IgA should be performed and interpreted in conjunction with the QUANTA Lite™ H. pylori IgG for the detection of IgG antibodies to H.pylori .
The QUANTA Lite™ H. pylori IgA kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgA antibodies to H. pylori (Helicobacter pylori) in human serum.
This document is a marketing approval letter for a medical device called QUANTA Lite™ H. pylori IgA ELISA. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.
To answer your request, I would need a study report or a different type of document that details the performance data and acceptance criteria for the QUANTA Lite™ H. pylori IgA ELISA device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
2003 APR 2
Mr. Brys C. Myers Manager, Regulatory Affairs INOVA Diagnostics, Inc. 10180 Scripps Ranch Boulevard San Diego, CA 92131-1234
Re: K024334
Trade/Device Name: QUANTA Lite™ H.pylori IgA ELISA Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter Fetus Serological Reagents Regulatory Class: Class I Product Code: LYR Dated: December 23, 2002 Received: December 26, 2002
Dear Mr. Myers:
This letter corrects our substantially equivalent letter of March 27, 2003, regarding the QUANTA Lite™ H. pylori IgA ELISA. The revised Indications for use are enclosed.
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).
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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 (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
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510(k) Number (if known): __|<024334
Device Name: QUANTA Lite™ H.pylori IgA ELISA
Indications For Use:
The QUANTA Lite™ H. pylori IgA kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgA antibodies to H. pylori (Helicobacter pylori) in human serum. This test is intended to aid in the diagnosis of H. pylori infection in adult patients 18 years or older with clinical signs and symptoms of gastrointestinal disease. The QUANTA Lite™ H. pylori IgA should be performed and interpreted in conjunction with
the QUANTA Lite™ H. pylori IgG for the detection of IgG antibodies to H.pylori .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Freddie In. Rode
(Division Sign-Off) Division of Clinical Laboratory Devices
510(k) Number K024334
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).