(107 days)
in-vitro measurement of IqA anticardiolipin antibodies in human serum, as an aid in the diagnosis of antiphospholipid syndrome (APS).
Not Found
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Anticardiolipin IgA Screen EIA Kit" (Trade Name) / "BINDAZYME® Anticardiolipin IgA EIA Kit" (Device Name):
It's important to note that the provided text is an FDA 510(k) clearance letter. This type of document primarily confirms substantial equivalence to a predicate device and permits marketing, rather than detailing full study results or specific acceptance criteria met. Therefore, much of the requested information (like specific test set sizes, expert qualifications, and detailed statistical results) is not present in this document. The FDA letter references a 510(k) submission, which would contain such details, but the letter itself does not.
However, based on the provided text, we can infer some information and identify what is explicitly missing.
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the FDA clearance letter. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance is comparable. It does not list specific sensitivity, specificity, or agreement percentages as acceptance criteria or reported performance for this device.
2. Sample size used for the test set and the data provenance
This information is not provided in the FDA clearance letter. The letter refers to a 510(k) submission, which would contain details about the study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the FDA clearance letter.
4. Adjudication method for the test set
This information is not provided in the FDA clearance letter.
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
An MRMC study is relevant for AI-assisted diagnostic devices. This device is an "Anticardiolipin IgA Screen EIA Kit," which is an in-vitro diagnostic (IVD) immunoassay kit, not an AI-powered image analysis or diagnostic assist device. Therefore, an MRMC study is not applicable to this type of device and would not have been conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is an IVD kit, not an algorithm. Its performance is inherent to the kit itself, which is used by laboratory personnel. The concept of "standalone algorithm performance" is not applicable to this type of device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The indications for use state "as an aid in the diagnosis of antiphospholipid syndrome (APS)." For an IVD measuring antibodies, the ground truth would typically be established through:
- Correlation with clinical diagnosis of APS (possibly based on expert clinical criteria, further laboratory tests, and patient outcomes).
- Comparison to a reference method or a well-characterized set of patient samples (e.g., samples from patients with confirmed APS and healthy controls).
- The FDA letter does not specify the exact ground truth methodology used in the underlying study.
8. The sample size for the training set
This information is not provided in the FDA clearance letter. For an IVD kit, the concept of a "training set" doesn't directly apply in the same way it does for machine learning algorithms. However, there would have been a development and validation phase where the kit's reagents and assay parameters were optimized using various sample cohorts. The size of these cohorts is not mentioned.
9. How the ground truth for the training set was established
As with the test set, the specifics are not provided. However, for an IVD, the ground truth for any development or validation cohort would similarly involve well-characterized patient samples with and without APS, or comparison against established reference methods for anticardiolipin IgA.
Summary of what is known from the provided text:
- Device Name: BINDAZYME® Anticardiolipin IgA EIA Kit
- Intended Use: In-vitro measurement of IgA anticardiolipin antibodies in human serum, as an aid in the diagnosis of antiphospholipid syndrome (APS).
- Regulatory Context: FDA 510(k) clearance, found substantially equivalent to a predicate device.
- Device Type: In-vitro diagnostic (IVD) immunoassay kit.
What is NOT known from the provided text (and would typically be in the full 510(k) submission):
- Specific performance metrics (sensitivity, specificity, accuracy).
- Detailed acceptance criteria for these metrics.
- Sample sizes for validation studies.
- Details about the patient cohorts (provenance, demographics).
- Exact ground truth establishment methods (beyond general implication for an IVD).
- Any information related to expert review or adjudication.
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Public Health Service
Image /page/0/Picture/2 description: The image shows a partial view of a logo, specifically the emblem of the U.S. Department of Health and Human Services (HHS). The emblem features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the wings. The word "DEPARTMENT" is partially visible, oriented vertically along the left edge of the image, indicating the logo is likely for a government department.
5 1959 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: K983696 Trade Name: Anticardiolipin IgA 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 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
BINDAZYME® Anticardiolipin IgA EIA Kit Device Name:
in-vitro measurement of IqA Use: The Indications for anticardiolipin antibodies in human serum, as an aid in the diagnosis of antiphospholipid syndrome (APS).
Peter E. Makin
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number _ 9831.91
§ 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).