(132 days)
A semiquantitative enzyme linked immunoasay for detecting IgG class autoantibody to βρ glycoprotein I (β GPT) for use as an aid in the diagnosis of of certain arcommand assessment lupus erythematosus disorders, such as those secondary to systemic lupus erythematosus disorders, Baon ake thrombotic diseases.
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Here's an analysis of the provided text regarding the acceptance criteria and study for the QUANTA Lite™ B₂GPI IgG device:
Based on the provided text, it is a 510(k) submission for a device called "QUANTA Lite™ Beta 2 GPI IgG ELISA" which is an in vitro diagnostic device. The documentation provided is an FDA clearance letter and an "Indications For Use" page. This type of document typically references a study that was submitted for substantial equivalence, but it does not contain the actual study details, acceptance criteria, or performance data within the provided excerpts.
Therefore, I cannot populate the table or answer most of your detailed questions directly from the given text. The text only states that the FDA has reviewed the submission and determined it to be "substantially equivalent" to predicate devices for the stated indications for use.
Below, I've outlined what I can infer or what is missing based on your request and the provided document:
Inferences and Missing Information:
1. A table of acceptance criteria and the reported device performance
- Missing. The provided text does not contain any acceptance criteria or reported device performance data. This information would typically be in the detailed study report submitted as part of the 510(k) application, which is not included here. For an ELISA assay, acceptance criteria would likely include sensitivity, specificity, accuracy, precision (intra-assay, inter-assay), linearity, and potentially comparison to a predicate device.
2. Sample size used for the test set and the data provenance
- Missing. The sample size for the test set and data provenance (e.g., country of origin, retrospective/prospective) are not mentioned in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Missing. This information is not provided. For an ELISA designed to detect autoantibodies related to specific diseases, the "ground truth" would likely be based on a clinical diagnosis or a consensus of clinical findings, potentially including confirmation from other established laboratory tests or clinical experts (e.g., rheumatologists).
4. Adjudication method for the test set
- Missing. The adjudication method (e.g., 2+1, 3+1, none) is not mentioned.
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
- Not Applicable / Missing. This device is an ELISA kit, which is an in vitro diagnostic assay, not an AI-powered image analysis or diagnostic support tool for human readers. Therefore, an MRMC study related to human readers improving with AI assistance would not be relevant or conducted for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Missing in context of AI. While the ELISA assay itself operates as a "standalone" test (generating a result without human interpretation of complex patterns, but rather a direct numerical or semi-quantitative output), the concept of "standalone algorithm performance" typically refers to the performance of an AI algorithm without human intervention, which is not relevant here. The device's performance stands alone as a laboratory test.
7. The type of ground truth used
- Inferred: Clinical Diagnosis / Established Laboratory Methods. For an in vitro diagnostic test like this, the ground truth for establishing performance (e.g., sensitivity and specificity) would typically be based on a confirmed clinical diagnosis of the conditions it aims to aid in diagnosing (e.g., systemic lupus erythematosus, thrombotic diseases), often supported by a combination of clinical criteria and results from other established, often more invasive or complex, diagnostic methods or predicate devices.
8. The sample size for the training set
- Missing. This device is a biochemical assay (ELISA), not a machine learning model. Therefore, the concept of a "training set" in the context of AI/ML is not directly applicable. If you're referring to method development or validation sets, the sample size is not stated.
9. How the ground truth for the training set was established
- Not Applicable. As noted above, this is not an AI/ML device that uses a "training set" in that sense.
Summary:
The provided document is an FDA clearance letter for an ELISA kit, confirming its substantial equivalence to a predicate device. It does not contain the detailed performance study, acceptance criteria, or methodological specifics that you are asking for. Those details would be found in the actual 510(k) submission document itself, which is typically much more extensive than these two pages.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and features the department's name around the perimeter. In the center is a stylized image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 4 1997
Brys Myers INOVA Diagnostics, Inc. 10451 Roselle Street San Diego, CA 92121 ---
Re: K970551/S001 Trade Name: QUANTA Lite™ Beta 2 GPI IgG ELISA Regulatory Class: II Product Code: MSV Dated: May 02, 1997 Received: May 05, 1997
Dear Mr. Myers:
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, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
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.
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This letter will allow you to begin marketing your device as described in your 5!0(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 Putman
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 | "011 |
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| - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
K970551 510(k) Number (if known):
QUANTA Lite™ B,GPI IgG Device Name:
Indications For Use:
A semiquantitative enzyme linked immunoasay for detecting IgG
entification of the commends of (8, GRI) for use as an aid class autoantibody to βρ glycoprotein I (β GPT) for use as an aid
class autoantibody to βρ glycoprotein I (β GPT) for use as an aid oantibody to β2 glycoprocein i (pp ord) assess thrombotic the in the diagnosis of of certain arcommand assessment lupus erythematosus
disorders, such as those secondary to systemic lupus erythematosus disorders, Baon ake thrombotic diseases.
Peter E. Mapin
Division of Clinical I 510(k) Nur
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IS NEGERD)
Concurrence of CDRB, Office of Device Evaluation (ODE)
Image /page/2/Picture/9 description: The image shows the words "Prescription Use" in bold font, with an underscore after the word "Use". Below this, in a smaller font, is the text "(Per 21 CFR 801.109)". There is a check mark above the underscore after the word "Use".
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).