(182 days)
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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, image processing, or data sets for training/testing.
No
This device is an in vitro diagnostic (IVD) test used to aid in the diagnosis of autoimmune diseases by detecting specific antibodies. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" states that the device is "to aid in the diagnosis of autoimmune diseases".
No
The device description explicitly states it is an "enzyme linked immunoassay (ELISA)", which is a laboratory test involving physical reagents and processes, not a software-only device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "detection of antinuclear and cytoplasmic antibodies in human serum to aid in the diagnosis of autoimmune diseases". This involves testing a sample taken from the human body (in vitro) to provide information for diagnostic purposes.
- Device Description: The device is described as an "enzyme linked immunoassay (ELISA)". ELISA is a common laboratory technique used for in vitro diagnostic testing.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device clearly fits this description.
N/A
Intended Use / Indications for Use
An enzyme linked immunoassay (ELISA) for the detection of antinuclear and cytoplasmic antibodies in human serum to aid in the diagnosis of autoimmune diseases such as Systemic Lupus Erythematosus (SLE), Sjögren's Syndrome (SS), Mixed Connective Tissue Disease (MCTD), and Scleroderma.
Product codes
LJM
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): 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.
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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.
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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).
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§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three stripes on its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 6 2004
Mr. Kevin J. Lawson Director, Regulatory Affairs IMMCO Diagnostics, Inc. 60 Pineview Drive Buffalo, New York 14228-2120
K041102 Re:
Ko 11102
Trade/Device Name: ImmuLisa Antinuclear Antibody Screen ELISA Regulation Number: 21 CFR § 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: II Product Code: LJM Dated: September 30, 2004 Received: October 7, 2004
Dear Mr. Lawson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becalling in (a) pening is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encroours) to trgang ment date of the Medical Device Amendments, or to connitier provision to may 20, 1978, the occordance with the provisions of the Federal Food, Drug, de vices mat nave been receire approval of a premarket approval application (PMA). and Cosmetic Ac. (11ct) that to nov requent of the general controls provisions of the Act. The 1 ou may, cherefore, mans of the Act include requirements for annual registration, listing of general controls profitering 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 If your device is olabsined (600 as colorols. Existing major regulations affecting your device can may be subject to sach adamental vol Regulations (CFR), Parts 800 to 895. In addition, FDA be round in Triro levels with the soncerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Toast of advised that I Drivedance or our device complies with other requirements of the Act that I Dri has made a word regulations administered by other Federal agencies. You must or any I catal battler and states and and the begine to registration and listing (21 CFR Parts 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice CPR Part 607), adoming (21 Ce quality systems (QS) regulation (21 CFR Part 820). This letter requirenches as set form in are quality device as described in your Section 510(k) premarket will anow you to begin marketing your antial equivalence of your device to a legally marketed nonfication. The PDF in a classification for your device and thus, permits your device to proceed to the market.
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If you desire specific information about the application of labeling requirements to your device, and In If you desire specific information and advertising of your device, please contact the Office of In
or questions on the promotion and advertising of your and accept of the of questions of the promotion and ad retising 65 301) 594-3084. Also, please note the Vitro Diagnostic Device Livanianon and Baroy in ( = ( = ) = ( = ) = ( = ( Part 807.97).
regulation entitled, "Misbranding by reference to premarket the Ast from the regulation entitled, "Misolanung by reiclenes on your responsibilities under the Act from the You may obtain other gelefal informations on Jour responser 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, 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
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Indications for Use
510(k) Number (if known): K041102
Device Name:
ImmuLisa Antinuclear Antibody Screen ELISA
Indications For Use:
An enzyme linked immunoassay (ELISA) for the detection of antinuclear and cytoplasmic antibodies in human serum to aid in antinuclear and cytoplashiks artibeares such as Systemic Lupus
the diagnosis of autoimmune diseases such as Systemic Lupus Erythematosus (SLE), Sjögren's Syndrome (SS), Mixed Erythematoous (Sease (MCTD), and Scleroderma.
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)
Mana Chan
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Office of In Vitro Diagnostic Device Evaluation and Safety
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