(90 days)
The QUANTA Lite™ sp100 kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-sp100 antibody of the IgG class in human serum. This test is intended to aid in the diagnosis of primary biliary cirrhosis (PBC).
The QUANTA Lite™ sp100 kit is an enzyme-linked immunosorbent assay (ELISA).
The provided text describes a 510(k) premarket notification for the "QUANTA Lite™ sp100 ELISA" device, which is an enzyme-linked immunosorbent assay for the semi-quantitative detection of anti-sp100 antibody of the IgG class in human serum, intended to aid in the diagnosis of primary biliary cirrhosis (PBC).
However, the provided document does not contain any information regarding specific acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert involvement as requested in the prompt. It is a regulatory approval letter and an "Indications For Use" statement, not a scientific study report.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the given text.
To answer your question, I would need a more detailed technical report, clinical study summary, or an FDA review memorandum that outlines the device's validation process and performance data.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
JUN 1 3 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
INOVA Diagnostics, Inc. c/o Dr. Gary L. Norman 10180 Scripps Ranch Blvd. San Diego, CA 92131
Re: K050662
Trade/Device Name: QUANTA Lite™ sp100 ELISA Regulation Number: 21 CFR 866.5090 Regulation Name: Antimitochondrial Antibody Immunological Test System Regulatory Class: Class II Product Code: NUM Dated: March 11, 2005 Received: March 29, 2005
Dear Dr. Norman:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 legally
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Page 2 – Dr. Gary L. Norman
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), please contact the Office of Compliance at (240) 276-0131. 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/dsma/dsmamain.html
Sincerely yours.
Robert H. Becker/
Robert L. Becker, Jr., M.D., PhD Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K050662
Device Name: QUANTA Lite™ sp100 ELISA
Indications For Use:
The QUANTA Lite™ sp100 kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-sp100 antibody of the IgG class in human serum. This test is intended to aid in the diagnosis of primary biliary cirrhosis (PBC).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mana Chen
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_ Ko-50662) ============================================================================================================================================================
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 866.5090 Antimitochondrial antibody immunological test system.
(a)
Identification. An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).(b)
Classification. Class II (performance standards).