(111 days)
Not Found
Not Found
No
The summary describes a standard ELISA assay for antibody detection, with no mention of AI or ML technologies.
No
The device is an ELISA assay designed for the detection of specific antibodies to aid in the diagnosis of primary biliary cirrhosis. It is an in vitro diagnostic (IVD) device, not a therapeutic one that treats or prevents a condition.
Yes
The device is described as aiding in the diagnosis of primary biliary cirrhosis, which is a diagnostic purpose.
No
The 510(k) summary describes an ELISA kit, which is a laboratory assay involving physical reagents and equipment, not a software-only device.
Yes, based on the provided information, the QUANTA Lite™ PBC Screen IgG/IgA ELISA is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that it is an "enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of mitochondrial antibodies, gp210 antibodies, and sp100 antibodies of the IgG and/or IgA class in human serum." This involves testing a sample taken from the human body (in vitro) to provide information about a person's health status.
- Diagnosis: The intended use also states that the results "can be used in conjunction with other clinical and laboratory findings to aid in the diagnosis of primary biliary cirrhosis." This directly relates to providing diagnostic information.
- Sample Type: The test is performed on "human serum," which is a biological sample taken from a patient.
These characteristics are fundamental to the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QUANTA Lite™ PBC Screen IgG/IgA ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of mitochondrial antibodies, gp210 antibodies, and sp100 antibodies of the IgG and/or IgA class in human serum. The presence of mitochondrial, gp210, and sp100 antibodies can be used in conjunction with other laboratory findings and clinical symptoms to aid in the diagnosis of primary biliary cirrhosis.
Product codes (comma separated list FDA assigned to the subject device)
DBM, NRI, NUM
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
INOVA Diagnostics, Inc. c/o Gary L. Norman, Ph.D. Senior Scientist 9900 Old Grove Rd. San Diego, CA 92131-1638
OCT 1 8 2006
Re: K061842
Trade/Device Name: QUANTA Lite™ PBC Screen IgG/IgA ELISA Regulation Number: 21 CFR 866.5090 Regulation Name: Anti-mitochondrial Antibody Immunological Test System Regulatory Class: Class II Product Code: DBM, NRI, NUM Dated: June 22, 2006 Received: June 29, 2006
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.
1
Page 2 -
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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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 A. Beckerf
Robert L. Becker, Jr., M.D., Pb.D. Director Division of Immunology and Hematology 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): K061842
Device Name:_QUANTA Lite™ PBC Screen IgG/IgA ELISA
Indications for Use:
The QUANTA Lite™ PBC Screen IgG/IgA ELISA is an enzyme-ilnked immunosorbent The QUANTA Lite - FDC Sciech ighty - Enon roomitochondrial antibodies, gp210
assay (ELISA) for the semi-quantitative detection of mitochen in human sorum. The assay (ELISA) for the Semi-quantitic tre lgG and/or lgA class in human serum. The antibodies, and sp100 antibodies of the ige androing. I scan be used in conjunction presence of millochondrial, gp210, and op roo antiboures of primary biliary cirrhosis.
Prescription Use (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)
Maria Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of
510(k)_061842