(186 days)
Not Found.
Not Found.
No
The summary describes a radioimmunoassay for detecting autoantibodies, which is a standard laboratory technique and does not mention any AI or ML components.
No
Explanation: The device is an in-vitro diagnostic assay used for the semiquantitative determination of autoantibodies and aids in diagnosis, rather than providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" states that the assay is for "in-vitro-diagnostic" determination and is "useful as an aid in the differential diagnosis of Myasthenia Gravis".
No
The device is described as a radioimmunoassay for in-vitro diagnostic determination of autoantibodies in human serum. This indicates a laboratory test involving physical reagents and samples, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The AChRAb Assay is a radioimmunoassay for the in-vitro-diagnostic semiquantitative determination of autoantibodies against the acetylcholine receptor in human serum."
The phrase "in-vitro-diagnostic" directly indicates that the device is intended for use in examining specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
N/A
Intended Use / 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.
Product codes
NST
Device Description
Not Found.
Mentions image processing
Not Found.
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Not Found.
Anatomical Site
human serum
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
Not Found.
Description of the training set, sample size, data source, and annotation protocol
Not Found.
Description of the test set, sample size, data source, and annotation protocol
Not Found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s)
Not Found.
Reference Device(s)
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found.
§ 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).
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