(50 days)
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No
The summary describes an ELISA assay, which is a laboratory test based on biochemical reactions, not AI/ML. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is an in vitro diagnostic assay used for detection of antibodies to aid in the diagnosis of celiac disease, rather than for treatment.
Yes
The intended use explicitly states that the device is "to aid in the diagnosis of patients with celiac disease and dermatitis herpetiformis."
No
The 510(k) summary describes an Enzyme-Linked Immunosorbent Assay (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:
- "In Vitro": The intended use clearly states the analysis is performed on "human serum," which is a biological sample taken outside of the living body.
- "Diagnostic": The purpose of the assay is to "aid in the diagnosis of patients with celiac disease and dermatitis herpetiformis." This directly relates to identifying a disease state.
The description of the device as an "enzyme linked immunosorbent assay (ELISA)" further confirms it's a laboratory test performed on biological samples, which is characteristic of IVDs.
N/A
Intended Use / Indications for Use
An enzyme linked immunosorbent assay (ELISA) for the detection and semi-quantitation of anti-tissue Transglutaminase IgA antibodies in human serum to aid in the diagnosis of patients with celiac disease and dermatitis herpetiformis.
Product codes
MVM
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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§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).
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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 eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 5 1999
Mr. Kevin Lawson Director of Regulatory Affairs IMMCO Diagnostics, Inc. 60 Pineview Drive Buffalo, New York 14228-2120
Re: · · K992878
Trade Name: ImmuLisa™ Anti-tissue Tranglutaminase (tTG) Antibody Test Regulatory Class: II Product Code: MVM Dated: August 25, 1999 Received: August 26, 1999
Dear Mr. Lawson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Steven Gutman
Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K992878
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Device Name: Anti-tissue-Transglutaminase Antibody Test
Indications For Use: An enzyme linked immunosorbent assay (ELISA) for the detection and semi-quantitation of anti-tissue Transglutaminase IgA antibodies in human serum to aid in the diagnosis of patients with celiac disease and dermatitis herpetiformis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Division Sign-Off) Division Sign-Off)
Division of Clinical Laboratory Devices 510(1) Number . -Prescription Use OR Over-The Counter-Use (Per 21 CFR 801.109) (Optional Format 1-2-96) 21