(133 days)
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Unknown
No
The summary describes a standard ELISA assay, which is a biochemical test and does not typically involve AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
The device is an in vitro diagnostic (IVD) test used to aid in diagnosis, not to treat or provide therapy.
Yes
The "Intended Use / Indications for Use" states that the device is "to aid in the diagnosis of pernicious anemia," which directly indicates its diagnostic purpose.
No
The device description explicitly states it is an "enzyme linked immunoassay (ELISA)", which is a laboratory test involving physical reagents and equipment, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used for the "detection and semi-quantitation of intrinsic factor antibodies in human serum to aid in the diagnosis of pernicious anemia." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information for diagnostic purposes.
- Device Description: The device is described as an "enzyme linked immunoassay (ELISA)," which is a common type of laboratory test performed in vitro.
These points clearly align 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
An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of intrinsic factor antibodies in human serum 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
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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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§ 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 circle around the symbol. The caduceus is a common symbol for healthcare and medicine, and the logo is used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
IMMCO Diagnostics, Inc. c/o Mr. Kevin Lawson Director of Regulatory Affairs 60 Pineview Drive Buffalo, NY 14228-2120
SEP 2 4 2007
Re: K071346
Trade/Device Name: ImmuLisa Intrinsic Factor Antibody ELISA Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: Class II Product Code: LIG Dated: September 04, 2007 Received: September 05, 2007
Dear Mr. Lawson:
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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The
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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 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) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 H. Becker
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):
510(k) Number (if known):
Device Name:
ImmuLisa Intrinsic Factor Antibody ELISA
Indications For Use:
An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of intrinsic factor antibodies in human serum to aid in the diagnosis of pernicious anemia.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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 M Chan
Jivision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety