(69 days)
The QUANTA Lite™ M2 EP (MIT3) ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of mitochondrial antibodies in human serum. The presence of mitochondrial antibodies can be used in conjunction with clinical findings to aid in the diagnosis of primary biliary cirrhosis.
The QUANTA Lite™ M2 EP (MIT3) ELISA is an enzyme-linked immunosorbent assay (ELISA)
The provided document is a 510(k) premarket notification letter from the FDA regarding the QUANTA Lite™ M2 EP (MIT3) ELISA device. While it states that the device is substantially equivalent to a predicate device, it does not contain the detailed study information needed to answer the questions about acceptance criteria and device performance.
Specifically, the document only provides:
- Device Name: QUANTA Lite™ M2 EP (MIT3) ELISA
- Intended Use: Semi-quantitative detection of mitochondrial antibodies in human serum to aid in the diagnosis of primary biliary cirrhosis.
- Regulatory Classification: Class II, Product Code DBM.
The document does NOT include any information on:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts and their qualifications used to establish ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone (algorithm-only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
To obtain this information, one would typically need to review the full 510(k) submission (not just the FDA's decision letter), which includes the detailed analytical and clinical performance studies conducted by the manufacturer.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image and is the only element present.
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
INOVA Diagnostics, Inc. c/o Mr. Brys C. Myers Vice President 9900 Old Grove Rd. San Diego, CA 92131-1638
OCT 2 7 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K052262
R052202
Trade/Device Name: QUANTA Lite™ M2 EP (MIT3) ELISA Regulation Number: 21 CFR 866.5090 Regulation Name: 21 OFF Condrial Antibody Immunological Test System Regulatory Class: Class II Product Code: DBM Dated: August 16, 2005 Received: August 19, 2005
Dear Mr. Myers:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 910(x) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate sommerce use stated in the encrosure/ to regally manifical Device Amendments, or to devices that prior to May 26, 1770, the chaomism and the provisions of the Federal Food, Drug, and Cosmetic flave been reclassified in accordance nof a premarket approval application (PMA). You may, Act (Act) that do thot require approval controls provisions of the Act. The general therefore, market the act include requirements for annual registration, listing of devices, good controls provisions of the net morade requibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mic existing major regulations affecting your device can be may be subject to such additional controllars. Title 21, Parts 800 to 898. In addition, FDA may publish found in the Oode ents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised mat 1 Dr. 3 issualled be addition of the requirements of the Act or that FDA made a decemination max your reserved by other Federal agencies. You must comply with any Federal Statules and regulations administration of to: registration and listing (21 CFR Part 807); an the Act s requirements, morading, vancerice requirements as set forth in the quality labeling (21 CFR Part 801); good managements of systems (QB) regalises (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) This letter will anow you to cogal mains of substantial equivalence of your device to legally premarket notification: "The PDF mining sification for your device and thus, permits your device to proceed to the market.
{1}------------------------------------------------
Page 2 -
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,
Robert L. Becker Jr.
Robert L. Becker, Jr., MD, PA Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
of ___________________________________________________________________________________________________________________________________________________________________________ Page
510(k) Number (if known): _ __________________________________________________________________________________________________________________________________________________
Device Name: QUANTA Lite™ M2 EP(MIT3) ELISA
Indications For Use:
: : : . .
.
The QUANTA Lite™ M2 EP (MIT3) ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of mitochondrial antibodies in human serum. (ELIOF) for the comit quantial antibodies can be used in conjunction with clinical The presentee of milloonomal anabo aid in the diagnosis of primary biliary cirrhosis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Marie M. Clark
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 052262
Prescription Use_v (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).