(164 days)
The VBL Serum Troponin I Test is intended for the qualitative determination of cardiac troponin I in human serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI).
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "Vancouver Biotech, Ltd. Rapid Human Cardiac Troponin I Test" or "Vancouver Biotech, Ltd. Serum Troponin I Test." This letter primarily discusses the regulatory approval process and acknowledges substantial equivalence to a predicate device.
Unfortunately, the provided document does not contain the detailed information required to answer your specific questions regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications. These details are typically found in the supporting technical sections of a 510(k) submission, which are not included in this FDA clearance letter.
Therefore, I cannot populate the table or provide answers to most of your questions based only on the provided text.
Here's what I can extract, and what is missing:
Information Extracted from the Document:
- Device Name: Vancouver Biotech, Ltd. Rapid Human Cardiac Troponin I Test or Vancouver Biotech, Ltd. Serum Troponin I Test
- Intended Use: "The VBL Serum Troponin I Test is intended for the qualitative determination of cardiac troponin I in human serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI)."
- Regulatory Class: Class II
- Product Code: MMI
- Type of Ground Truth (implied): The test is for the qualitative determination of cardiac troponin I in human serum. This implies the ground truth for performance evaluation would likely be a reference method for troponin I measurement, or clinical diagnosis of AMI confirmed by other means.
Missing Information (Not Available in the Provided Text):
- A table of acceptance criteria and the reported device performance: This document confirms regulatory clearance but does not present the specific performance metrics (e.g., sensitivity, specificity, accuracy) or the acceptance thresholds that were used in the testing.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of in vitro diagnostic test, as ground truth is typically established by laboratory reference methods or clinical diagnosis, not expert consensus on images.
- Adjudication method for the test set: Not applicable for this type of in vitro diagnostic test.
- 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. This is an in vitro diagnostic device, not an AI-assisted diagnostic imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "test system" for qualitative determination, implying a standalone performance evaluation against a reference. However, the details of such a study (its results, design, and outcome) are not in this document.
- The type of ground truth used: While it's implied to be related to clinical diagnosis of AMI and/or a reference method for troponin I, the specific method used for the study is not detailed.
- The sample size for the training set: Not applicable, as this is an in vitro diagnostic test, not typically "trained" in the way an AI algorithm is.
- How the ground truth for the training set was established: Not applicable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines that also suggest human profiles.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 3 - 2003
Vancouver Biotech Ltd. c/o Ms. Robin J. Hellen, M.S. Hellen Professional Services 9418 Lasaine Avenue Northridge, CA 91325
Re: K023505
Trade/Device Name: Vancouver Biotech, Ltd. Rapid Human Cardiac Troponin I Test or Vancouver Biotech, Ltd. Serum Troponin I Test Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: January 24, 2003 Received: January 29, 2003
Dear Ms. Hellen:
This letter corrects the SE letter dated March 31, 2003. The indications for use wording was incorrect. It now reads "The VBL Serum Troponin I Test is intended for the qualitative determination of cardiac Troponin I in human serum". The word used before was quantitative. It was changed to qualitative.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the includions 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. Drig. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), 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, isting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Degister.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 20).
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of xyour device to 10(x) marketed predicate device results in a classification for your device and thus, serveits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of Vn Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please onte the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll the (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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PART I – General Information
Premarket Notification
Vancouver Biotech, Ltd. VBL Serum Troponin I Test
·CONFIDENTIAL•
STATEMENT FOR INDICATIONS FOR USE IV.
| 510(k) Number (if known): | K023505 |
|---|---|
| Device Name: | Vancouver Biotech, Ltd.Rapid Human Cardiac Troponin I TestOr VBL Serum Troponin I Test |
Indications for Use:
The VBL Serum Troponin I Test is intended for the qualitative determination
of cardiac troponin I in human serum. Measurement of troponin I values
are useful in the evaluation of acute myocardial infarction (AMI).
Concurrence of the CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | X |
|---|---|
| OR | |
| Over the Counter Use: | _________________ |
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
| 510(k) | K023 505 |
|---|---|
| -------- | ---------- |
l C
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.