(64 days)
AST/GOT measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
The Wako L-Type GOT.J2 test is an in vitro assay for the quantitative determination of glutamic-0xaloacetic transaminase (GOT) activity in serum.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Type |
|---|---|---|
| Correlation | 0.9996 correlation coefficient against predicate | Comparative Study |
| Regression Equation | y = 1.055x + 2.38 against predicate | Comparative Study |
| Precision | Acceptable values obtained on a day-to-day basis | Precision Studies |
| Minimum Detectable Level | 4 IU/L | Analytical Performance |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "comparison studies," but the number of samples or patients included in these studies is not provided.
- Data Provenance: Not explicitly stated. There is no mention of the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable/not stated. The ground truth for this diagnostic device (Wako L-Type GOT.J2 test) is established by comparing its performance against a predicate device (Wako UA 30R GOT product) and through analytical precision studies, not through expert consensus on interpretation.
- Qualifications of Experts: Not applicable/not stated.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As the comparison is analytical (device vs. predicate device), an adjudication method for human interpretation is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) for quantitative determination of GOT activity, not an imaging device or a device requiring human interpretation of complex outputs in the same way an AI-assisted diagnostic tool might. The comparison is between two analytical assays.
- Effect Size: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Yes, the described performance is a standalone performance of the L-Type GOT.J2 test. As an in vitro diagnostic assay, its performance (correlation, regression, precision, minimum detectable level) is inherent to the assay itself and does not involve a human-in-the-loop for its primary function of measuring GOT activity.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth is indirectly established by comparison to a legally marketed predicate device (Wako UA 30R GOT product) for which safety and effectiveness have already been demonstrated. The predicate device's results serve as the reference standard for the "correlation" and "regression equation" studies. For "precision," the ground truth is the inherent reproducibility of the assay itself.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not stated. This document describes a traditional in vitro diagnostic assay, not a machine learning or AI-based device that would typically involve a "training set" in the common sense. The development of such assays involves reagent formulation and analytical validation, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. As mentioned above, this document does not describe an AI/ML development process with a training set and corresponding ground truth.
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DEC 1 6 1999
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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:
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Burtis, C.A. and Ashwood, E.R., Ed.: Tietz Textbook of Clinical Chemistry, 20d Ed., Saunders, Philadelphia, 1994.
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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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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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| 510(k) Number (if known): | K993468 |
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| Device Name: | Wako L-Type GOT Test |
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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)
§ 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.