(16 days)
Not Found
No
The device description details a standard enzymatic kinetic assay for measuring AST activity, relying on spectrophotometric detection of NADH oxidation. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is for in vitro diagnostic use, specifically for quantitative determination of AST activity in human serum, which aids in diagnosis and treatment, but does not directly provide therapy.
Yes
The intended use explicitly states, "The intended use for the N-ASSAY L AST/GOT Reagent is for the quantitative determination of serum aspartate aminotransferase (AST) activity in human serum in the diagnosis and treatment of certain types of liver, heart, and muscle diseases." This indicates its purpose is to aid in diagnosis.
No
The device is a reagent, which is a chemical substance used in a laboratory test. It is a physical component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For in vitro diagnostic use only."
- Purpose: The device is intended for the "quantitative determination of serum aspartate aminotransferase (AST) activity in human serum in the diagnosis and treatment of certain types of liver, heart, and muscle diseases." This is a diagnostic purpose performed on a biological sample (human serum) outside of the body.
- Device Description: The description details a chemical reaction and measurement method used to analyze a component of a biological sample.
These points clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use for the N-ASSAY L AST/GOT Reagent is for the quantitative determination of serum aspartate aminotransferase (AST) activity in human serum in the diagnosis and treatment of certain types of liver, heart, and muscle diseases. For in vitro diagnostic use only.
Product codes
CIT
Device Description
The N-ASSAY L AST/GOT reagent is based on an the optimized enzymatic AST kinetic method as recommended by the Japan Society of Clinical Chemistry, shows good correlation with similar AST reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is convenient ready-to-use liquid type reagent.
In this procedure, L-Aspartic Acid and alpha-Ketoglutaric Acid are translated by aspartate aminotransferase (AST) to produce Oxalacetic Acid and Glutamic Acid. Oxalacetic Acid is reduced by Malic Dehydrogenase to produce Malic Acid with the concurrent oxidation of nicotinamide adenine dinucleotide reduced (NADH) to nicotinamide adenine dinucleotide (NAD). The NADH absorbs light at 340 nm (main) and 405 nm (sub) and can be detected spectrophotometrically. The decrease per minute in absorbance measured at 340 nm (main) and 405 (sub), due to the decrease of NADH, is directly proportional to the AST activity in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Liver, heart, and muscle
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
Comparison studies against the predicate assay (without the optional pyridoxal-5-phosphate or P5P activation) showed a correlation coefficient of 0.99178 and a regression equation y = 0.9754 x + -0.5665 with serum samples.
Comparison studies against the predicate assay (with the optional P5P activation) showed a correlation coefficient of 0.97146 and a regression equation y = 0.5807 x + 1.5184 with serum samples.
Precision studies indicate acceptable values can be obtained on a day to day basis.
The minimum detectable level of this method is 1 IU/L.
The N-ASSAY L AST/GOT reagent is linear to 2,000 IU/L.
Key Metrics
Correlation coefficient: 0.99178 (without P5P activation), 0.97146 (with P5P activation)
Regression equation: y = 0.9754 x + -0.5665 (without P5P activation), y = 0.5807 x + 1.5184 (with P5P activation)
Minimum detectable level: 1 IU/L
Linearity: to 2,000 IU/L
Predicate Device(s)
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.
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CRESTAT DIAGNOSTICS, INC
MAR 26 1998 25549 Adams Avenue Murrieta, CA 92562
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
K980902 The assigned 510(k) number is:
Date: March 2, 1998
Submitted by: Colin Getty KAMIYA BIOMEDICAL COMPANY 910 Industry Drive, Seattle WA 98188 TEL: 206-575-8068; FAX: 206-575-8094
For:
Crestat Diagnostics, Inc. 25549 Adams Avenue Murrieta, CA 92562
N-ASSAY L AST/GOT (AST Assay Reagent) Product:
Aspartate aminotransferase (AST/GOT) is widely distributed with high concentrations in the heart, liver, skeletal muscle, and kidney. Damage or disease to any of these tissues may result in raised serum or plasma levels of AST. Karmen et al. described the first kinetic assay of AST for diagnostic purposes in 1955. Since then, this method has been improved and forms the basis of many national and international recommended procedures.
The N-ASSAY L AST/GOT reagent is based on an the optimized enzymatic AST kinetic method as recommended by the Japan Society of Clinical Chemistry, shows good correlation with similar AST reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is convenient ready-to-use liquid type reagent.
In this procedure, L-Aspartic Acid and a-Ketoglutaric Acid are translated by aspartate aminotransferase (AST) to produce Oxalacetic Acid and Glutamic Acid. Oxalacetic Acid is reduced by Malic Dehydrogenase to produce Malic Acid with the concurrent oxidation of nicotinamide adenine dinucleotide reduced (NADH) to nicotinamide adenine dinucleotide (NAD). The NADH absorbs light at 340 nm (main) and 405 nm (sub) and can be detected spectrophotometrically. The decrease per minute in absorbance measured at 340 nm (main) and 405 (sub), due to the decrease of NADH, is directly proportional to the AST activity in the sample.
1
CRESTAT DIAGNOSTICS, INC.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)
The safety and effectiveness of the liquid Crestat N-ASSAY L AST/GOT Reagent is demonstrated by its substantial equivalence to the Boehringer Mannheim Corporation AST liquid reagent (K861792) which is based on a similar enzymatic method as recommended by the IFCC. Both test systems are intended to quantitatively measure AST activity in human serum.
In comparison studies against the predicate assay (without the optional pyridoxal-5phosphate or P5P activation), a correlation coefficient of 0.99178 and a regression equation y = 0.9754 x + -0.5665 was obtained with serum samples. In comparison studies against the predicate assay (with the optional P5P activation), a correlation coefficient of 0.97146 and a regression equation y = 0.5807 x + 1.5184 was obtained with serum samples. Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is 1 IU/L. The N-ASSAY L AST/GOT reagent is linear to 2,000 IU/L.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three human figures in the negative space between the wings and body of the eagle.
MAR 26 1998 2098 Gaither Road
Food and Drug Administration Rockville MD 20850
Crestat Diagnostics, Inc. C/O Colin Getty KAMIYA Biomedical Company 910 Industry Drive Seattle, Washington, 98188
K980902 e : N-ASSAY L AST/GOT Requlatory Class: II Product Code: CIT March 2, 1998 Dated: Received: March 10, 1998
Dear Mr. Getty:
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 reqistration, 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 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 Reqister. 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/dsmamain.html".
sincerely yours,
Steven Litman
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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INDICATIONS FOR USE STATEMENT
K980902 510(k) Number (if known):
N-ASSAY L AST/GOT (AST Assay Reagent) Device Name:
Indications For Use:
The intended use for the N-ASSAY L AST/GOT Reagent is for the quantitative determination of serum aspartate aminotransferase (AST) activity in human serum in the diagnosis and treatment of certain types of liver, heart, and muscle diseases. For in vitro diagnostic use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Laboratory vices
510(k) Number K980902
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
Optional Format 1-2-96)
OR