(25 days)
Intended for the the In Vitro, quantitative determination of AST (GOT) activity in human serum on automated chemistry analyzers. "Aspartate amino transferase (AST/SGOT) measurements are used in the diagnosis and treatment of certain types of liver and heart disease.... " CFR 862.1100
AST (GOT) LIQUID STABLE 2 VIAL - (DST) REAGENT
This document is an FDA 510(k) clearance letter for a medical device (AST (GOT) Liquid Stable 2 Vial Reagent Incorporating DST). It is a regulatory approval document and does not contain the information requested in your prompt regarding acceptance criteria, study details, or AI performance metrics.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This document does not describe performance metrics or acceptance criteria for the device itself beyond its intended use.
- Sample sizes used for the test set and the data provenance: No study details are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No study details are provided.
- Adjudication method for the test set: No study details are provided.
- 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: This device is a diagnostic reagent, not an AI system or imaging device requiring human reader interpretation in the context of an MRMC study.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
- The type of ground truth used: No study details are provided.
- The sample size for the training set: Not applicable, as this is not an AI algorithm.
- How the ground truth for the training set was established: Not applicable, as this is not an AI algorithm.
What the document does state about the device:
- Device Name: AST (GOT) Liquid Stable 2 Vial Reagent Incorporating DST
- Indications for Use: Intended for the in vitro, quantitative determination of AST (GOT) activity in human serum on automated chemistry analyzers.
- Purpose of AST (GOT) measurements (from CFR 862.1100): Used in the diagnosis and treatment of certain types of liver and heart disease.
- Regulatory Classification: Class II
- Determination: Substantially equivalent to devices marketed prior to May 28, 1976.
To answer your prompt, you would need a clinical study report or a 510(k) summary document that typically accompanies this clearance letter, which would describe the performance characteristics and testing conducted for the device.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 30 1956
David Johnston . TAI Technical Director TRACE America, Inc. 7260 Northwest 58th Street Miami, Florida 33166
K980030 Re : AST (GOT) Liquid Stable 2 Vial Reagent Incorporating DST Requlatory Class: II Product Code: CIT Dated: December 23, 1997 Received: January 5, 1998
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, Druq, 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 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 requiations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the Current Good-Manufacturing Practice requirements; as set --forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 -requlations.
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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 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Bitman
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 1 of
510(k) Number (if known): Device Name: _ AST (GOT) LIQUID STABLE 2 VIAL - (DST) REAGENT_ Indications for Use:
Intended for the the In Vitro, quantitative determination of AST (GOT) activity in human serum on automated chemistry analyzers.
"Aspartate amino transferase (AST/SGOT) measurements are used in the diagnosis and treatment of certain types of liver and heart disease.... " CFR 862.1100
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)
for a Montgomery
Division Sign-Off) Sign-Off)
of Clinical Laboratory Devices 510(k) Number
§ 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.