(107 days)
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Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML technology in medical devices. The intended use and predicate device suggest a standard in-vitro diagnostic assay.
No
The device is intended for in-vitro measurement of anticardiolipin antibodies to aid in diagnosis, not to directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" states "as an aid in the diagnosis of antiphospholipid syndrome (APS)," which clearly indicates a diagnostic purpose.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. The intended use describes an in-vitro measurement, which typically involves laboratory equipment and reagents, suggesting a hardware component is likely involved. However, without a device description, it's impossible to definitively confirm.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states "The in-vitro measurement of anticardiolipin antibodies in human serum". The term "in-vitro" is a key indicator of an IVD, meaning the test is performed outside of the living body, typically on samples like blood or serum.
- Measurement of Analytes: The device measures "anticardiolipin antibodies", which are specific substances (analytes) in the human sample. This is a characteristic function of IVD devices.
- Aid in Diagnosis: The intended use also states it is "as an aid in the diagnosis of antiphospholipid syndrome (APS)". IVDs are commonly used to provide information that assists healthcare professionals in making diagnoses.
- Predicate Device: The mention of a "Predicate Device" with the name "Anticardiolipin IgM Screen EIA Kit" further supports that this device is an IVD. Predicate devices are legally marketed devices that are substantially equivalent to the new device, and the predicate device listed is clearly an IVD kit.
While other sections like "Device Description" and performance data are "Not Found", the core information in the "Intended Use" and the presence of a relevant "Predicate Device" are sufficient to classify this device as an IVD.
N/A
Intended Use / Indications for Use
The in-vitro measurement of anticardiolipin antibodies in human serum, as an aid in the diagnosis of antiphospholipid syndrome (APS).
Product codes
MID
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
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
Public Health Service
5 1999 FEB
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
The Binding Site, Limited C/O Mr. Jay H. Geller East Tower, Suite 600 2425 West Olympic Boulevard Santa Monica, California 90404
Re: K983694 Trade Name: Anticardiolipin IgM Screen EIA Kit Regulatory Class: II Product Code: MID Dated: January 12, 1999 Received: January 20, 1999
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 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). 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 (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 requirements, 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 Register. 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
2
BINDAZYME® Anticardiolipin IgM EIA Kit Device Name:
I dM Indications Use: The in-vitro measurement of for anticardiolipin antibodies in human serum, as an aid in the diagnosis of antiphospholipid syndrome (APS).
Peter E. Makem
(Division Sign-Off) Division of Clinical Laboratory Devices, 510(k) Number
Prescription ✓