(28 days)
Intended for the In Vitro, quantitative determination of Amylase in human serum and urine for clinical diagnosis.
"This Amylase test system is a device intended to measure the activity of the enzyme amylase in serum, and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas)". , CFR 862.1070
TRACE Amylase - DST Reagent
The provided documents are a 510(k) premarket notification letter from the FDA for a device called "TRACE Amylase - DST Reagent." This is not a study report or clinical trial document for a medical AI/ML device. Therefore, it does not contain the information required to answer the questions about acceptance criteria and the study proving the device meets them.
The 510(k) letter confirms that the device is "substantially equivalent" to predicate devices already on the market, meaning it has similar indications for use and technological characteristics. It does not elaborate on specific performance data or studies beyond stating that a review was conducted.
To answer your questions, I would need a document that describes a clinical or analytical study performed to evaluate the performance of an AI/ML medical device, including acceptance criteria and results.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized symbol that resembles a caduceus, with three figures or lines that appear to be abstract representations of people or a staff with intertwined snakes, a common symbol for health and medicine.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
David Johnston Technical Director TRACE America, Inc. · 7260 North West 58th Street Miami, Florida 33166
JUL 17 1997
Re : K972297 Amylase-Incorporating Dynamic Stabilization Technoloqy Regulatory Class: II Product Code: JFJ Dated: June 6, 1997 Received: June 19, 1997
Dear Mr. Johnston:
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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. 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 diaqnostic 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/dsmamain.html".
sincerely yours,
Steven Gutman
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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510(k) Number (if known): (to be assigned) Device Name: TRACE Amylase - DST Reagent
Indications for Use:
Intended for the In Vitro, quantitative determination of Amylase in human serum and urine for clinical diagnosis.
"This Amylase test system is a device intended to measure the activity of the enzyme amylase in serum, and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas)". , CFR 862.1070
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K972297 |
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)
§ 862.1070 Amylase test system.
(a)
Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).(b)
Classification. Class II.