(182 days)
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.
An enzyme linked immunoassay (ELISA)
Here's an analysis of the provided text to extract the requested information about device acceptance criteria and the study that proves the device meets those criteria:
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
Based on the provided text, the document is a 510(k) clearance letter from the FDA. This type of document declares "substantial equivalence" to a predicate device but does not typically contain the detailed acceptance criteria or the full study protocols and results. The letter mentions that the device is substantially equivalent "for the indications for use stated in the enclosure," but the enclosure itself (page 2 of the document) only lists the Indications for Use, not specific performance acceptance criteria.
Therefore, much of the requested information cannot be directly extracted from this document. However, I can infer some aspects based on the nature of a 510(k) submission for an ELISA diagnostic.
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. A 510(k) clearance letter typically states the device is substantially equivalent, implying that its performance meets the standards comparable to a predicate device, but it doesn't detail the specific criteria or the results against them.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document only states the device's indications for use.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided in the document. Given that this is an ELISA diagnostic (a laboratory test that directly measures antibodies), a MRMC study, which typically involves human readers interpreting images, is unlikely to be the primary method for demonstrating effectiveness. Performance for such devices is usually assessed through analytical and clinical precision, accuracy, sensitivity, and specificity studies.
6. Standalone Performance Study
While not explicitly stated as "standalone performance study," the entire 510(k) submission for an ELISA likely includes analytical and clinical performance data for the algorithm/test itself (without human interpretation in the loop, beyond running the test and reading the quantitative results). However, the specific details of such a study are not included in this clearance letter.
7. Type of Ground Truth Used
This information is not provided in the document. For an ELISA for autoimmune diseases, ground truth would typically be established by a combination of clinical diagnosis (based on symptoms and other tests), and potentially other reference assays or biopsy/pathology for specific conditions if applicable.
8. Sample Size for the Training Set
This information is not provided in the document. Training sets are more relevant for machine learning algorithms; for a traditional ELISA, "training" isn't applicable in the same sense, though assay development and optimization phases would involve extensive testing.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document. (See point 8).
Summary of Document Contents Regarding Acceptance Criteria and Study Details:
The provided document is an FDA 510(k) clearance letter for the ImmuLisa Antinuclear Antibody Screen ELISA. It confirms the device's substantial equivalence to a predicate device for its stated Indications for Use. However, the letter does not contain the detailed acceptance criteria or the specifics of the studies (like sample sizes, ground truth establishment, expert qualifications, or detailed performance metrics) that led to this clearance. These details would typically be found in the full 510(k) submission document, which is not provided here.
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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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Page 2
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
Division Sign-Off
Division Sign-Of
Office of In Vitro Diagnostic Device Evaluation and Safety
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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).