(372 days)
EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instrument Phadia 100.
EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instrument Phadia 250.
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This document is a 510(k) summary, not a detailed study report. Therefore, it primarily focuses on the "Indications for Use" and the substantial equivalence determination rather than a comprehensive description of acceptance criteria and a deep dive into the study details. However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain a table of specific acceptance criteria (e.g., sensitivity, specificity thresholds) or detailed reported device performance metrics in a structured table format. The EliA™ SmDP Immunoassay is an "Antinuclear Antibody Immunological Test System" (21 CFR §866.5100), and its performance would typically be evaluated based on its ability to detect IgG antibodies directed to Sm with acceptable sensitivity and specificity for aid in the clinical diagnosis of systemic lupus erythematosus (SLE).
Without a dedicated section on performance data, it's impossible to create the requested table from the provided text.
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set or its data provenance (e.g., country of origin, retrospective/prospective). This information would typically be found in the detailed study report submitted as part of the 510(k) application.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish the ground truth for any test set. For immunological assays like this, the "ground truth" often involves clinical diagnosis of SLE based on established ACR or SLICC criteria, which might involve expert physicians, but this isn't detailed here.
4. Adjudication method for the test set
The document does not mention any adjudication method used for a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This device, the EliA™ SmDP Immunoassay, is an in vitro diagnostic (IVD) assay designed to semi-quantitatively measure antibodies. It is not an AI-based device that would typically involve "human readers" or "AI assistance" in the way a medical imaging AI device would. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable to this type of device, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is an IVD immunoassay, essentially a laboratory test system. Its "performance" is inherently standalone in the sense that the assay results are generated by the instrument (Phadia 100 or Phadia 250) based on the sample, without real-time human interpretation affecting the raw measurement. The human-in-the-loop comes in when a clinician interprets the results in conjunction with other clinical findings. The document doesn't provide a specific study abstract, but the nature of an immunoassay implies standalone analytical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the "Indications for Use" state "as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings," the ground truth for evaluating the device's performance would most likely be established based on clinical diagnosis of SLE, potentially using established classification criteria (e.g., American College of Rheumatology (ACR) criteria or Systemic Lupus International Collaborating Clinics (SLICC) criteria), which implicitly involves a form of expert consensus and possibly other laboratory and pathology findings. The document itself doesn't explicitly state the methodology for establishing this ground truth for the studies conducted.
8. The sample size for the training set
The document does not provide details about a training set or its sample size. For an immunoassay, the concept of a "training set" in the context of machine learning (where this question typically applies) is not directly relevant. Instead, the assay's parameters would be established during development and analytical validation, which involves calibration and analytical studies, not a "training set" as understood in AI/ML.
9. How the ground truth for the training set was established
As in point 8, the concept of a "training set" and its ground truth establishment, as typically applied to AI/ML, isn't directly applicable for this type of immunoassay. The clinical "ground truth" for evaluating its diagnostic utility would be established through clinical studies, as described in point 7.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2014
PHADIA US, INC. C/O MR. MARTIN ROBERT MANN SENIOR REGULATORY AFFAIRS MANAGER 4169 COMMERCIAL AVENUE PORTAGE, MI, 49002
Re: K132631
| Trade/Device Name: | EliA™ SmDP Immunoassay |
|---|---|
| Regulation Number: | 21 CFR §866.5100 |
| Regulation Name: | Antinuclear Antibody Immunological Test System |
| Regulatory Class: | Class II |
| Product Code: | LKP |
| Dated: | July 28, 2014 |
| Received: | July 31, 2014 |
Dear Mr. Mann:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Elizabeth A. Stafford -S
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K132631
Device Name EliA(TM) SmDP
Indications for Use (Describe)
EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instrument Phadia 100.
EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instrument Phadia 250.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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).