(164 days)
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No
The summary describes a qualitative immunoassay for cardiac troponin I and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is strictly for diagnostic purposes, specifically for the qualitative determination of cardiac troponin I to evaluate acute myocardial infarction, and does not provide any therapeutic benefit or treatment.
Yes
The device is intended for the "qualitative determination of cardiac troponin I in human serum" and "useful in the evaluation of acute myocardial infarction (AMI)", which are diagnostic purposes.
No
The summary describes a test for cardiac troponin I in human serum, which implies a laboratory or point-of-care test that would involve physical reagents and potentially hardware for analysis. There is no mention of software as the primary or sole component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "qualitative determination of cardiac troponin I in human serum." This involves testing a biological sample (serum) outside of the body (in vitro) to gain information about a medical condition (acute myocardial infarction).
- Sample Type: The device uses "human serum," which is a biological sample commonly used in in vitro diagnostic testing.
These points clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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).
Product codes
MMI
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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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 Test | |
| Or 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 |
|---|---|
| -------- | ---------- |
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