(345 days)
For the in-vitro measurement of IgA autoantibodies against B2-glycoprotein 1 (B2GP1) present in human serum. This kit may be used in conjunction with anticardiolipin assays and clinical information to aid the diagnosis of thrombosis in at risk patients having, for example, antiphospholipid syndrome (APS) or systemic lupus erythematosus (SLE).
Not Found
This 510(k) summary does not contain the detailed study information required to fully answer all of your questions regarding acceptance criteria and study design. The document is primarily a notification of FDA clearance for the Bindazyme® Anti-B2 GP1 IgA EIA Test Kit, indicating that it has been deemed substantially equivalent to a legally marketed predicate device.
However, based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state acceptance criteria or detailed device performance metrics such as sensitivity, specificity, or accuracy. It primarily grants market clearance based on "substantial equivalence" to a predicate device. To get this information, one would need to review the full 510(k) submission (if available publicly) or relevant performance studies from the manufacturer.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided document. Given that this is an in-vitro diagnostic (IVD) test, the ground truth would likely be established by other laboratory methods or clinical diagnoses rather than expert human interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided document.
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
Given that this is an in-vitro diagnostic (IVD) test kit for measuring autoantibodies in human serum, a multi-reader multi-case (MRMC) comparative effectiveness study with human readers assisting AI is not applicable. This type of study is relevant to image-based AI diagnostics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an "EIA Test Kit," which implies a laboratory-based immunoassay. Its performance is inherent to the kit itself, therefore, its "standalone" performance (without human-in-the-loop interpretation beyond running the assay and reading results) is what would typically be evaluated. However, specific details of this evaluation are not provided in the document.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For an in-vitro diagnostic test for autoantibodies, the ground truth would typically be established by:
- Clinical diagnosis of APS/SLE: based on established medical criteria.
- Confirmation with other validated laboratory methods: such as Western blot, indirect immunofluorescence, or other established assays for autoantibodies.
- Patient outcomes data: linked to the clinical diagnosis and presence of thrombosis.
The document does not specify which type of ground truth was used for the studies supporting its substantial equivalence. It mentions the kit aids in the diagnosis of thrombosis in at-risk patients with APS or SLE, implying the ground truth would relate to these conditions.
8. The sample size for the training set
This information is not available in the provided document. For an immunoassay kit, the concept of a "training set" is less direct than with AI algorithms. It would refer to samples used during the assay development and optimization phases.
9. How the ground truth for the training set was established
This information is not available in the provided document. Similar to point 7, it would likely involve clinically characterized samples and/or comparison to established methods.
In summary, the provided document is a regulatory approval letter and not a detailed study report. It confirms the device's market clearance but does not elaborate on the specific performance metrics, study designs, sample sizes, or ground truth establishment methods in the way a full clinical study report would.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three wavy lines above three smaller wavy lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY - 5 2000
The Binding Site c/o Mr. Jay H. Geller West Tower, Suite 4000 2425 West Olympic Boulevard Santa Monica, California 90404
Re: K991802 Trade Name: Bindazyme® Anti-B2 GP1 IgA EIA Test Kit Regulatory Class: II Product Code: MSV Dated: March 31, 2000 Received: April 4, 2000
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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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" (21CFR 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
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Page_ |of
510(k) Number (if known): _ | 99 / 807-
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
INDICATIONS FOR USE STATEMENT
Bindazyme® Anti-B2 GP1 IgA EIA Test Kit Device Name:
for ' Use: For the in-vitro measurement of IgA Indications autoantibodies against B2-glycoprotein 1 (B2GP1) present in human This kit may be used in conjunction with anticardiolipin serum. assays and clinical information to aid the diagnosis of thrombosis in at risk patients having, for example, antiphospholipid syndrome (APS) or systemic lupus erythematosus (SLE) .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
tute E. Maleni
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991802
Prescription Use √
(Per 21 CFR 801.109)
OR
一,
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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).