(186 days)
The AChRAb Assay is a radioimmunoassay for the in-vitro-diagnostic semiquantitative determination of autoantibodies against the acetylcholine receptor in human serum.
The AChRAb assay is useful as an aid in the differential diagnosis of Myasthenia Gravis (MG) in conjunction with other clinical and laboratory findings.
Not Found
This document is an FDA 510(k) clearance letter for an in vitro diagnostic device, not an AI/ML medical device. Therefore, it does not contain the specific information requested about acceptance criteria, study designs with test and training sets, expert adjudication, or comparative effectiveness studies for AI.
This document confirms the substantial equivalence of the "AChRAb Acetylcholine Receptor Ab Kit" to a legally marketed predicate device. The indications for use state it is a radioimmunoassay for the in-vitro-diagnostic semiquantitative determination of autoantibodies against the acetylcholine receptor in human serum, useful as an aid in the differential diagnosis of Myasthenia Gravis (MG) in conjunction with other clinical and laboratory findings.
Due to the nature of this document (an FDA 510(k) clearance for an in vitro diagnostic kit, not an AI/ML device), the requested information about acceptance criteria and the study proving the device meets those criteria, as typically described for AI/ML devices, cannot be fully provided from the given text.
However, I can extract what is implicitly present and acknowledge what is missing based on the typical requirements for such devices:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not explicitly state quantitative acceptance criteria or detailed device performance results in a table format. For an in vitro diagnostic kit like this, performance is typically demonstrated through analytical and clinical performance studies, often including data on sensitivity, specificity, precision, accuracy, and linearity. These results would be compared against predefined criteria for the assay to be considered acceptable. The 510(k) clearance implies that such studies were submitted and found acceptable by the FDA, but the details are not included in this letter.
2. Sample Size for Test Set and Data Provenance:
Not specified in the provided text. For an IVD kit, this would typically involve various cohorts including healthy individuals and patients with the target condition (Myasthenia Gravis) and possibly other relevant conditions.
3. Number of Experts and Qualifications for Ground Truth:
Not specified in the provided text. For diagnostic kits, ground truth for clinical performance can be established by established clinical diagnosis (e.g., based on clinical presentation, other diagnostic tests, and expert medical opinion), but there's no mention of specific experts establishing ground truth for a test set in the AI/ML sense.
4. Adjudication Method:
Not applicable or specified in the provided text. Adjudication methods like 2+1 or 3+1 are typically for reconciling discrepancies in expert annotations for AI ground truth, which is not the context here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI/ML device, so there would be no effect size of human readers improving with AI vs. without AI assistance.
6. Standalone Performance Study:
Since this is an in vitro diagnostic kit, its performance is inherently "standalone" in the sense that the kit itself provides the measurement. The clinical performance studies would demonstrate its performance in isolating the target analyte and providing accurate results against a clinical diagnosis. However, this is not a "standalone algorithm performance" in the AI/ML context.
7. Type of Ground Truth Used:
While not explicitly stated for a "test set" in the AI/ML context, the clinical utility of an in vitro diagnostic assay like the AChRAb kit would be evaluated against a clinical diagnosis of Myasthenia Gravis, which is established by a combination of clinical symptoms, neurological examination, and other diagnostic tests.
8. Sample Size for Training Set:
Not applicable. This is not an AI/ML device, so there is no concept of a "training set" in the machine learning sense. The assay itself is a biochemical test.
9. How Ground Truth for Training Set was Established:
Not applicable as there is no training set in the AI/ML context. The development of an IVD assay involves extensive research and development to optimize the assay components and parameters (e.g., antibody concentrations, incubation times, cutoff values) to achieve optimal performance, but this is a different process from establishing ground truth for machine learning training data.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
NOV 20 2009
NC:
IVD Technologies, Inc. c/o Mr. Gary Lehnus Lehnus & Associates consulting 150 Cherry Lane Road East Stroudsburg, PA 18301
Re: K091468
Trade/Device Name: AchRAb Acetycholine Receptor Ab Kit Regulation Number: 21 CFR §866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: NST Dated: October 08, 2009 Received: October 15, 2009
Dear Mr. Lehnus:
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 (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 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 forth in the quality systems
{1}------------------------------------------------
Page 2 – Mr. Gary Lehnus
(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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.html 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
ia m chan
Maria M. Chan, 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): K091468
Device Name: IVD Technologies AChRAb test kit
Indications For Use:
The AChRAb Assay is a radioimmunoassay for the in-vitro-diagnostic semiquantitative determination of autoantibodies against the acetylcholine receptor in human serum.
The AChRAb assay is useful as an aid in the differential diagnosis of Myasthenia Gravis (MG) in conjunction with other clinical and laboratory findings.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OIVD)
Prescription Use × (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Maria In Chen
Division Sign-Off
Office of In Vitro Dlagnostic Device Evaluation and Safety
510(k) Ko9 1468
§ 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).