(25 days)
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No
The summary describes a chemical reagent for laboratory testing and does not mention any AI or ML components.
No.
The device is an in vitro diagnostic reagent used to measure AST activity, which aids in the diagnosis and treatment of diseases but does not itself provide a therapeutic effect.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurements are "used in the diagnosis and treatment of certain types of liver and heart disease," which defines it as a diagnostic device.
No
The device description clearly states "AST (GOT) LIQUID STABLE 2 VIAL - (DST) REAGENT", indicating a physical reagent, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Intended for the the In Vitro, quantitative determination of AST (GOT) activity in human serum". "In Vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Sample Type: The device is used to analyze "human serum," which is a biological sample taken from the body.
- Purpose: The purpose is to measure "AST (GOT) activity," which is a specific biological marker used in the diagnosis and treatment of diseases.
- Regulatory Reference: The mention of "CFR 862.1100" points to the Code of Federal Regulations section that likely pertains to clinical chemistry tests, which are a category of IVDs.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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
Product codes
CIT
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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§ 862.1100 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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
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