(123 days)
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No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
The device is described as an "in-vitro Measurement of Spectric rige" to aid in diagnosis, not to treat or cure a disease.
Yes
The "Intended Use / Indications for Use" states that the assay is intended "to aid in the diagnosis of certain types (Mro) present in Serum, as an ara in che and can conserulonephritis of aucolimatic vasourcess, in: ading onjunction with other clinical findings." This directly indicates a diagnostic purpose.
No
The intended use describes an "in-vitro Measurement of Spectric rige a aid in the diagnosis of certain types (Mro) present in Serum". This strongly suggests a laboratory assay or test kit, which involves physical reagents and potentially hardware for analysis, not a software-only device. The lack of a device description further supports this interpretation as it doesn't provide any information to contradict the implication of a physical assay.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "This assay is intended for the in-vitro Measurement..." - This directly indicates that the device is used outside of the body ("in-vitro") to measure something.
- "...to aid in the diagnosis of certain types (Mro) present in Serum..." - This clarifies that the measurement is performed on a biological sample (Serum) and is intended to assist in diagnosis.
These phrases are key indicators of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This assay is intended for the in-vitro Measurement of Spectric rige a aid in the diagnosis of certain types (Mro) present in Serum, as an ara in che and can conserulonephritis of aucolimatic vasourcess, in: ading onjunction with other clinical findings.
Product codes
MOB
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping bodies.
Jul 201998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
The Binding Site, LTD. c/o Jay H. Geller East Tower, Suite 600 2425 West Olymic Boulevard Santa Monica, CA 90404
K981030 Re : Bindazyme Anti-MPO Enzyme Immunoassay Kit Trade Name: Requlatory Class: II Product Code: MOB Dated: June 11, 1998 Received: June 15, 1998
Dear Mr. Geller:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Anti-MPO Enzyme Immunoassay Kit Device Name:
Indications for Use: This assay is intended for the in-vitro Measurement of Spectric rige a aid in the diagnosis of certain types (Mro) present in Serum, as an ara in che and can conserulonephritis of aucolimatic vasourcess, in: ading onjunction with other clinical findings.
Peter J. Minium
(Division Sign-Off) Division of Clinical Laboratory Device 510(k) Number
Prescription Use