(81 days)
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No
The summary describes a standard ELISA kit for antibody detection, with no mention of AI or ML terms, image processing, or data analysis methods typically associated with AI/ML.
No
This device is an in-vitro diagnostic (IVD) kit used for the semi-quantitative detection of an antibody in human serum to aid in the diagnosis of a condition. It does not directly provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" states that the results are "intended to aid in the diagnosis of primary biliary cirrhosis (PBC)."
No
The device description explicitly states it is an "enzyme-linked immunosorbent assay (ELISA) kit," which is a laboratory test involving physical reagents and equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "semi-quantitative detection of anti-gp210 antibody of the IgG class in human serum" and is "intended to aid in the diagnosis of primary biliary cirrhosis (PBC)". This clearly indicates it's used to test a sample taken from the human body (serum) to provide information for diagnostic purposes.
- Device Description: It's described as an "enzyme-linked immunosorbent assay (ELISA)", which is a common type of in vitro diagnostic test.
These points align directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The QUANTA Lite™ gp210 kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-gp210 antibody of the IgG class in human serum. In conjunction with other laboratory findings and clinical symptoms, results are to be used as an aid in the diagnosis of primary biliary cirrhosis (PBC).
Product codes
NRI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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 stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 5 2004
Gary L. Norman, Ph.D. Senior Scientist 10180 Scripps Ranch Blvd. San Diego, CA 92131-1234
Re: K040885
Trade/Device Name: QUANTA Lite™ gp210 ELISA Regulation Number: 21 CFR 866.5090 Regulation Name: Antimitochondrial antibody immunological test system Regulatory Class: Class II Product Code: NRI Dated: May 21, 2004 Received: June 1, 2004
Dear Dr. Norman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bection brokey personally equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars) to regars and the Medical Device Amendments, or to commerce proc to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, de vices that have been receasined in quire approval of a premarket approval application (PMA). and Cosmetic Act (11ct) that to hor requestly of the general controls provisions of the Act. The 1 out may, mercrore, market and act include requirements for annual registration, listing of general controls provisions of the riot 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 In may be subject to such additional come Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in This 21, overments concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Ficase oe advised that I Dri 3 issuance or our device complies with other requirements of the Act that I DA has made a dolorimiation administered by other Federal agencies. You must of ally if ederal statutes and regulations and limited to: registration and listing (21 comply with an the 110 - 115 - 11 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) I his letter will anow you to oegin maneting your and equivalence of your device to a legally prematket notification: "The PDF inturly sification 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 specific mornation as advertising of your device, please contact the Office of In of questions on the promotion and Safety at (301) 594-3084. Also, please note the v itto Diagnostic Derreo Branding by reference to premarket notification" (21CFR Part 807.97). regulation entitled, "Misoranams" "Misormation on your responsibilities under the Act from the Tou may oount other general results 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 L. Becker
Robert L. Becker, Jr., MD, Ph.D Director Division of Immunology and Hematology 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): ____________________________________________________________________________________________________________________________________________________
Device Name: QUANTA Lite™ gp210 ELISA
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Indications For Use:
The QUANTA Lite™ gp210 kit is an enzyme-linked immunosorbent assay (ELISA) for The QUANTA Lite - gp210 kit is an eneyno infoody of the IgG class in human serum.
the semi-quantitative detection of anti-gp210 antibody of the IgG cass in human serum.
In an the semi-quartified to aid in the diagnosis of primary biliary cirrhosis (PBC).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Maria Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040885
Prescription Use_✓ (Per 21 CFR 801.109)
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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)