(64 days)
Wako UA 30R GOT product
No
The summary describes a standard in vitro diagnostic assay for measuring enzyme activity, with no mention of AI or ML in the device description, intended use, or performance studies.
No
Explanation: The device is an in vitro diagnostic assay used for the quantitative determination of enzyme activity in serum, which aids in diagnosis. It does not directly provide therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section states that AST/GOT measurements are "used in the diagnosis and treatment of certain types of liver and heart disease." This explicitly indicates a diagnostic purpose.
No
The device is an in vitro diagnostic assay, which involves chemical reagents and laboratory procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: It explicitly states that AST/GOT measurements are used in the diagnosis and treatment of certain types of liver and heart disease. This indicates a diagnostic purpose.
- Device Description: It describes the device as an "in vitro assay for the quantitative determination of glutamic-0xaloacetic transaminase (GOT) activity in serum." The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of a living organism, which is a hallmark of IVDs.
- Input Imaging Modality: It states "Not Applicable (In vitro diagnostic device)," further confirming its nature as an IVD.
- Anatomical Site: It states "Not Applicable (In vitro diagnostic device)," again consistent with an IVD.
The information provided clearly indicates that the Wako L-Type GOT.J2 test is designed to be used on biological samples (serum) outside of the body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Wako L-Type GOT.J2 test is an in vitro assay for the quantitative determination of glutamic-0xaloacetic transaminase (GOT) activity in serum. AST/GOT measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
Product codes
CIT
Device Description
Glutamic-oxaloacetic transaminase (GOT), an enzyme that catalyzes transamination of Laspartate and x-ketoglutarate to glutamate and oxaloacetate, is abundantly distributed in the cardiac muscle, liver, brain and other organs. GOT measurements are used in the diagnosis and treatment of certain types of liver and heart diseases. A commonly used method of GOT assay is the UV kinetic method. The Wako L-Type GOT.J2 is a reagent kit for GOT assay. 1
Principle: When a sample is mixed with substrate-enzyme and α-KG, glutamate and oxaloacetate are formed from L-aspartate and x-ketoglutarate in a reaction catalyzed by GOT in the sample. The oxaloacetate thus produced is converted to malate by malate dehydrogenase (MDH) and at the same time, NADH is oxidized to NAD. By measuring the decrease in absorbance at 340 nm due to the oxidation of NADH, GOT activity in the sample is determined.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and effectiveness of the Wako Wako L-Type GOT.J2 Test is demonstrated by its substantial equivalency to the Wako UA 30R GOT product. Both test systems are used to measure to measure GOT in the serum. In comparison studies against the predicate assay, a correlation coefficient of 0.9996 and a regression equation of y = 1.055x + 2.38 was obtained. Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is 4 IU/L.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient of 0.9996, regression equation of y = 1.055x + 2.38, minimum detectable level of 4 IU/L.
Predicate Device(s)
Wako UA 30R GOT product (no K/DEN number provided within the document for this product), K993468 (this is the subject device's own K number given in the FDA clearance letter, not a predicate mentioned in the summary)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
DEC 1 6 1999
Image /page/0/Picture/1 description: The image contains a sequence of characters and numbers. The sequence starts with the letter 'K', followed by the numbers '993468'. The characters and numbers are written in a handwritten style, with varying stroke thicknesses.
Wako
Wako Chemicals USA. Inc.
1600 Bellwood Road, Richmond, VA 23237 U.S.A. Telephone (804) 271-7677 Telex 293208 WAKO UR(RCA) Facsimile (804) 271-7791
510(K) Summary of Safety and Effectiveness
The Wako L-Type GOT.J2 test is an in vitro assay for the quantitative determination of glutamic-0xaloacetic transaminase (GOT) activity in serum.
Summary:
Glutamic-oxaloacetic transaminase (GOT), an enzyme that catalyzes transamination of Laspartate and x-ketoglutarate to glutamate and oxaloacetate, is abundantly distributed in the cardiac muscle, liver, brain and other organs. GOT measurements are used in the diagnosis and treatment of certain types of liver and heart diseases. A commonly used method of GOT assay is the UV kinetic method. The Wako L-Type GOT.J2 is a reagent kit for GOT assay. 1
Principle:
When a sample is mixed with substrate-enzyme and α-KG, glutamate and oxaloacetate are formed from L-aspartate and x-ketoglutarate in a reaction catalyzed by GOT in the sample. The oxaloacetate thus produced is converted to malate by malate dehydrogenase (MDH) and at the same time, NADH is oxidized to NAD. By measuring the decrease in absorbance at 340 nm due to the oxidation of NADH, GOT activity in the sample is determined.
The safety and effectiveness of the Wako Wako L-Type GOT.J2 Test is demonstrated by its substantial equivalency to the Wako UA 30R GOT product. Both test systems are used to measure to measure GOT in the serum. In comparison studies against the predicate assay, a correlation coefficient of 0.9996 and a regression equation of y = 1.055x + 2.38 was obtained. Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is 4 IU/L.
References:
-
Burtis, C.A. and Ashwood, E.R., Ed.: Tietz Textbook of Clinical Chemistry, 20d Ed., Saunders, Philadelphia, 1994.
-
DG Klinische Chemie Mitteilungen 26 (1995) Heft 5.
Amma Mallum
Wako Diagnostics Tonya Martory, Sr. Manager September 22, 1999 1600 Bellwood Road Richmond, VA 23237
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus-like symbol, with three parallel lines curving upwards and to the right, resembling a stylized human profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 6 1999
Ms. Tonya Mallory Senior Manager Wako Diagnostics 1600 Bellwood Road Richmond, Virginia 23237
Re: K993468 Trade Name: Wako L-Type GOT Test Regulatory Class: II Product Code: CIT Dated: September 23, 1999 Received: October 13, 1999
Dear Ms. Mallory:
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 legally marketed predicate 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. 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 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 action. In addition, FDA may publish further announcements 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 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/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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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FKI 10:41 PM JUL
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| 510(k) Number (if known): | K993468 |
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| Device Name: | Wako L-Type GOT Test |
rua ucu
Indications For Use:
AST/GOT measurements are used in the diagnosis
and treatment of certain types of liver and
heart disease.
(Division Sign-Off) oper
Division of Clinical Laboratory Devices
510(k) Number 1993468
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use/
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)