(176 days)
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No
The summary describes a standard ELISA assay, which is a biochemical test and does not involve AI or ML. There are no mentions of AI, ML, image processing, or data analysis techniques typically associated with AI/ML.
No
The device is an ELISA for the detection of Intrinsic factor antibodies, which aids in diagnosis rather than providing therapy.
Yes
The device is described as aiding in the diagnosis of pernicious anemia by detecting Intrinsic factor antibodies, which is a diagnostic purpose.
No
The device is an ELISA kit, which is a laboratory test involving physical reagents and equipment, not a software-only device.
Yes, based on the provided information, the QUANTA Lite™ Intrinsic factor ELISA is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "semi-quantitative detection of Intrinsic factor antibodies in human serum." This involves testing a sample taken from the human body (serum) outside of the body (in vitro) to provide information about a person's health status (aiding in the diagnosis of pernicious anemia).
This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QUANTA Lite™ Intrinsic factor ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of Intrinsic factor antibodies in human serum. The presence of Intrinsic factor antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of pernicious anemia.
Product codes
LIG
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
Prescription Use
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
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Key Metrics
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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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§ 862.1810 Vitamin B
12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.
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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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 2 2006
INOVA Diagnostics, Inc. c/o Gary L. Norman, Ph.D. 9900 Old Grove Road Senior Scientist San Diego, CA 92131-1638
DEC 2 2006
Re: K061841
Trade/Device Name: QUANTA Lite™ Intrinsic Factor ELISA Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 Test System Regulatory Class: Class II Product Code: LIG Radioassay, intrinsic factor blocking antibody 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert Becker Jr
Robert L. Becker, Jr., M.D., Ph.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): K061841
Device Name:_QUANTA Lite™ Intrinsic Factor ELISA
Indications for Use:
The QUANTA Lite™ Intrinsic factor ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of Intrinsic factor antibodies in human serum. The presence of Intrinsic factor antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of pernicious anemia.
Prescription Use X (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)
Robert Becker
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K061841
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