(28 days)
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No
The summary describes a quantitative assay for a chemical marker (ALT) using automated chemistry analyzers, with no mention of AI/ML terms, image processing, or data-driven algorithms.
No
The device is described as an "In Vitro" diagnostic for determining ALT activity in human serum, which is used for diagnosis and treatment of conditions, but it does not directly treat or prevent a disease or condition.
Yes
The device is intended for the quantitative determination of ALT (GPT) activity in human serum, and this measurement is explicitly stated as being used in the "diagnosis and treatment of certain types of liver and heart diseases." This direct link to diagnosis makes it a diagnostic device.
No
The 510(k) summary describes an in vitro diagnostic device for measuring ALT activity in human serum. This type of device typically involves reagents and laboratory equipment, which are hardware components, not solely software. The lack of a device description further supports this, as a software-only device would likely have a description focusing on the software's function and platform.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Intended for the In Vitro, quantitative determination of ALT (GPT) activity in human serum". "In Vitro" means "in glass" or "outside of the body," which is a key characteristic of IVDs.
- Sample Type: The device analyzes "human serum," which is a biological sample taken from the body.
- Purpose: The purpose is to measure a specific analyte (ALT/GPT activity) in that sample for diagnostic purposes ("used in the diagnosis and treatment of certain types of liver... and heart diseases").
The provided information directly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended for the In Vitro, quantitative determination of ALT (GPT) activity in human serum on automated chemistry analyzers.
"Alanine amino transferase (ALT/SGPT) measurements are used in the diagnosis and treatment of certain types of liver (e.g. viral hepatitis and cirrhosis) and heart diseases." CFR 862.1030
Product codes
CKA
Device Description
ALT (GPT) LIQUID STABLE 2 VIAL - (DST) REAGENT
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1030 Alanine amino transferase (ALT/SGPT) test system.
(a)
Identification. An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB - 2 19
David Johnston . TAI Technical Director TRACE America, Inc. 7260 Northwest 58th Street 33166 Miami, Florida
K980028 Re : AST (GPT) Liquid Stable 2 Vial Reagent Incorporating DST Requlatory Class: II CKA Product Code: December 23, 1997 Dated: January 5, 1998 Received:
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 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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. Please note: concerning your device in the Federal Reqister. 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 requlation (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 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 Pitman
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): ¥980028 Device Name: _ ALT (GPT) LIQUID STABLE 2 VIAL - (DST)_REAGENT Indications for Use:
Intended for the In Vitro, quantitative determination of ALT (GPT) activity in human serum on automated chemistry analyzers.
"Alanine amino transferase (ALT/SGPT) measurements are used in the diagnosis and treatment of certain types of liver (e.g. viral hepatitis and cirrhosis) and heart diseases." CFR 862.1030
(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)
fand for R. Montgomery
Division Sign-Off Division of Clinical Laboratory Devices 510(k) Number
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