(49 days)
For the quantitative determination of Aspartate Aminotransferase (AST) in serum. Aspartate Aminotransferase determination is use for the diagnosis of certain liver and heart diseases.
AST/SGOT LIQUID REAGENT - KINETIC METHOD
The provided document is a 510(k) clearance letter from the FDA for an AST/SGOT Liquid Reagent - Kinetic Method device. This type of document does not typically contain the detailed study information or acceptance criteria as outlined in your request for AI/diagnostic imaging devices.
The 510(k) clearance process demonstrates substantial equivalence to a predicate device, rather than requiring extensive clinical trials with specific performance metrics and acceptance criteria in the same way newer, high-risk devices or AI-driven diagnostics do.
Therefore, I cannot extract the specific information you've requested from these pages. The document confirms:
- Device Name: AST/SGOT LIQUID REAGENT - KINETIC METHOD
- Intended Use: "For the quantitative determination of Aspartate Aminotransferase (AST) in serum. Aspartate Aminotransferase determination is use for the diagnosis of certain liver and heart diseases."
To answer your questions about acceptance criteria and study data, one would typically need access to the 510(k) submission document itself, which would include performance data from the manufacturer's internal studies comparing their device to the predicate. This information is not present in the FDA's clearance letter.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 9 1998
Rhoda Filipina Official FDA Correspondent Teco Diagnostics 4925 E. Hunter Avenue Anaheim, California 92807
K981650 Re : AST/SGOT Liquid Reagent - Kinetic Method Requlatory Class: II Product Code: CIT April 24, 1998 Dated: Received: May 11, 1998
Dear Ms. Filipina:
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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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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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 qeneral 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 "dsmo@fdadr.cdrh.fda.gov".
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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K981650 510(k) Number (if known):_
Device Name: AST/SGOT LIQUID REAGENT - KINETIC METHOD
Indiations For Use;
For the guantitative determination of Aspartate Aminotransferase (AST) in serum. Aspartate Aminotransferase determination is use for the diagnosis of certain
liver and heart diseases.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Device Evaluation (ODE)
Carol C Benav Alfred Montrym
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981650
. . . . . . . .
Prescription, Use (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.
(a)
Identification. An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.