(66 days)
No
The device description details a purely enzymatic and photometric method for measuring AST, with calibration data stored on a magnetic stripe. There is no mention of AI or ML algorithms for data processing, interpretation, or decision-making.
No
Explanation: The device is used for the in vitro quantitative determination of AST in whole blood or serum, which aids in the diagnosis and treatment of certain liver and heart diseases. It is a diagnostic device that provides information for treatment decisions, rather than a device that directly administers therapy or alters the body's function for therapeutic purposes.
Yes
The Intended Use / Indications for Use section states that "AST measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis), and heart diseases." This explicitly indicates the device's role in diagnosis.
No
The device description clearly outlines a system that includes physical components like a cassette, an analyzer, and utilizes enzymatic methodology and reflectance photometry, indicating it is a hardware-based system with associated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the in vitro quantitative determination of AST in whole blood or serum". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The description details how the device analyzes a sample (whole blood or serum) using enzymatic methodology and solid-phase technology to measure a substance (AST) within that sample. This process is performed outside of the patient's body.
- Purpose: The AST measurements are used in the diagnosis and treatment of certain diseases, which is a typical application for IVDs.
- Sample Type: The device uses biological samples (whole blood or serum) collected from the patient.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cholestech LDX aspartate aminotransferase (AST) test is for the in vitro quantitative determination of AST in whole blood or serum on the Cholestech LDX Analyzer.
AST measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis), and heart diseases.
Product codes
CIS
Device Description
The Cholestech LDX System combines enzymatic methodology and solid-phase technology to measure AST. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin coated capillary tube), venous whole blood or serum. The sample is applied to a Cholestech LDX AST cassette. The cassette is then placed into the Cholestech LDX Analyzer where a unique system on the cassette separates the plasma from the blood cells. The plasma flows to both sides of the cassette and is transferred to the AST reaction pad.
The Cholestech LDX Analyzer measures Aspartate aminotransferase by an enzymatic method based on the method formulation of Katsuyama et al. 12- Aspartic acid aminotransferase catalyzes the transfer of amino groups from L-Aspartic acid to alpha-Ketoglutarate producing oxaloacetate and glutamate. Oxaloacetate Decarboxylase converts the Oxaloacetate to Pyruvate by the removal of CO2. Pyruvate oxidase, in the presence of oxygen, oxidizes the pyruvate to acetylphosphate and hydrogen peroxide. In a reaction catalyzed by horseradish peroxidase, the peroxide reacts with an indicator dye to form a blue color at a rate proportional to the AST concentration of the sample. The resultant color in the reaction is measured by reflectance photometry.
A brown magnetic stripe on each cassette contains the calibration required for the Cholestech LDX Analyzer to convert the reflectance reading to the AST concentration in U/L. 37°C.
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
Professional-Use, point-of-care
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
- Assay range: 10 -- 400 U/L
- Hematocrit tolerance: up to 50%
- Interference testing: less than 10% interference when challenged by evaluated levels of endogenous and exogenous (therapeutic) substances
- Precision: 2 levels of Controls (Low- ~31 U/L AST, and High- ~106 U/L AST) were tested in duplicate, twice a day, over a 20 day period for a total of 80 replicates per level. The percent coefficient of variation (%CV) from the testing of the Low Control was 8.8%, and 4.4% from the testing of the High Control. When the same testing protocol was performed with a whole blood sample at 58 U/L, the %CV was 4.8%.
- Accuracy: The LDX AST test was compared to the Synchron CX AST test with 109 matched serum samples.
- n: 109, slope: 0.97, y-intercept: 1.6, “r”: 0.983, Range of Values: 12 – 396 U/L (LDX AST vs Synchron CX AST)
- A study was performed where results obtained from testing whole blood samples (both venous and fingerstick) on the LDX were compared to results obtained from testing matched serum samples on the LDX.
- n: 46, slope: 1.08, y-intercept: 0.3, "r": 0.998, Range of Values: 13 - 343 U/L (LDX AST: venous whole blood samples vs serum samples)
- n: 21, slope: 0.86, y-intercept: 4.4, "r": 0.934, Range of Values: 13 - 65 U/L (LDX AST: fingerstick whole blood samples vs serum samples)
Key Metrics
Not Found
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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510(k) SUMMARY
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.
The assigned 510(k) number is: K032021
Submitter Information (21 CFR 807.92(a)(1))
| Submitter: | Cholestech Corporation |
|---|---|
| 3347 Investment Boulevard | |
| Hayward, CA 94545 | |
| phone: (510) 732-7200 | |
| fax: (510) 732-7227 |
Thomas E. Worthy, PhD. Contact: Vice President, Research and Regulatory Affairs Cholestech Corporation.
Summary Date: June 30, 2003
Name of Device and Classification (21 CFR 807.92(a)(2))
Name (trade): Cholestech LDX aspartate aminotransferase (AST)
Name (usual): Colorimetric assay for the determination of aspartate amino transferase (SGOT/AST)
Classification: 21 CFR 862.1100, Class II, CIS (75)
Identification of Legally Marketed Predicate Device(s) (21 CFR 807.92 (a)(3))
LDX AST is substantially equivalent to the Synchron CX® AST system (Synchron CX, Beckman Coulter, Inc., Fullerton, CA). The LDX AST method is identical or similar to its predicate in terms of: intended use, measurement principle (enzymatic reactions), measurement (assay) range, specimen type, and the requirement for an analyzer.
1
Description of Device (21 CFR 807.92 (a)(4))
The Cholestech LDX System combines enzymatic methodology and solid-phase technology to measure AST. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin coated capillary tube), venous whole blood or serum. The sample is applied to a Cholestech LDX AST cassette. The cassette is then placed into the Cholestech LDX Analyzer where a unique system on the cassette separates the plasma from the blood cells. The plasma flows to both sides of the cassette and is transferred to the AST reaction pad.
The Cholestech LDX Analyzer measures Aspartate aminotransferase by an enzymatic method based on the method formulation of Katsuyama et al. 12- Aspartic acid aminotransferase catalyzes the transfer of amino groups from L-Aspartic acid to alpha-Ketoglutarate producing oxaloacetate and glutamate. Oxaloacetate Decarboxylase converts the Oxaloacetate to Pyruvate by the removal of CO2. Pyruvate oxidase, in the presence of oxygen, oxidizes the pyruvate to acetylphosphate and hydrogen peroxide. In a reaction catalyzed by horseradish peroxidase, the peroxide reacts with an indicator dye to form a blue color at a rate proportional to the AST concentration of the sample. The resultant color in the reaction is measured by reflectance photometry.
Image /page/1/Figure/5 description: This image shows a series of four chemical reactions. In the first reaction, L-Aspartic acid and alpha-Ketoglutarate react with Aspartate Aminotransferase to produce Oxaloacetate and Glutamate. In the second reaction, Oxaloacetate reacts with Oxaloacetate Decarboxylase to produce Pyruvate and CO2. In the third reaction, Pyruvate, Phosphate, O2, and H2O react with Pyruvate Oxidase to produce Acetylphosphate, CO2, and H2O2. In the fourth reaction, Indicator and H2O2 react with Peroxidase to produce Colored Blue Dye and H2O.
A brown magnetic stripe on each cassette contains the calibration required for the Cholestech LDX Analyzer to convert the reflectance reading to the AST concentration in U/L. 37°C.
Intended Use (21 CFR 807.92 (a)(5))
The Cholestech LDX aspartate aminotransferase (AST) test is for the in vitro quantitative determination of aspartate aminotransferase (AST) in whole blood or serum on the Cholestech LDX Analyzer. AST measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis), and heart diseases.
2
:
Similarities to the Predicate(s) (21 CFR 807.92 (a)(6))
A summary table of the similarities and differences between the LDX AST and the predicate device follows.
| Device Name | LDX AST
(new device) | Synchron CX® AST
(K952427) |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for use | The Cholestech LDX aspartate
aminotransferase (AST) test is for
the in vitro quantitative
determination of AST in whole
blood or serum on the Cholestech
LDX Analyzer. | The Synchron CX reagent, in conjunction with
the Synchron® Enzyme Validator Set, is
intended for the quantitative determination of
AST activity in serum or plasma on Synchron
CX Clinical Systems. |
| | AST measurements are used in the
diagnosis and treatment of certain
liver diseases (e.g., viral hepatitis
and cirrhosis), and heart diseases. | AST measurements are used in the diagnosis
and treatment of certain types of liver and
heart diseases. |
| Instrument
Required | LDX Analyzer | Synchron CX Clinical System |
| Technology | Enzymatic methodology and a
solid-phase technology | Enzymatic rate method; appropriate sample
and reagent volumes are introduced to the
system's cuvette. |
| Assay Range | 10 to 400 U/L | 5 to 400 U/L |
| Sample Type | Whole blood (capillary and venous)
and serum | Serum or plasma |
| Calibration
Requirements | No calibration performed by the
user; test information is encoded on
the magnetic stripe of the cassette,
and the stripe is read by the LDX
Analyzer each time a cassette is
run. | Calibration required via the use of the
Synchron Enzyme Validator Set; under typical
operating conditions, the AST reagent
cartridge must be calibrated every 5 days, and
also with certain parts replacement or
maintenance procedures. |
| Testing | Professional-Use, point-of-care | Professional-Use, conventional laboratory |
Comparison Table: Cholestech LDX AST vs Beckman Coulter Synchron CX AST
3
| Device Name | LDX AST
(new device) | Synchron CX® AST
(K952427) |
|-------------|-------------------------|-------------------------------|
| Environment | | |
Brief Discussion of Nonclinical and Clinical Performance Data (21 CFR 807.92(b)(1,2, 3)}
- 10 -- 400 U/L Assay range: .
- up to 50% Hematocrit tolerance: .
- less than 10% interference when challenged by evaluated levels of . Interference testing: endogenous and exogenous (therapeutic) substances
- Precision: 2 levels of Controls (Low- ~31 U/L AST, and High- ~106 U/L AST) were tested . in duplicate, twice a day, over a 20 day period for a total of 80 replicates per level. The percent coefficient of variation (%CV) from the testing of the Low Control was 8.8%, and 4.4% from the testing of the High Control. When the same testing protocol was performed with a whole blood sample at 58 U/L, the %CV was 4.8%.
- Accuracy: The LDX AST test was compared to the Synchron CX AST test with 109 . matched serum samples. The comparative data appear below (Synchron CX on x-axis).
| LDX AST vs Synchron CX AST | ||||
|---|---|---|---|---|
| n | slope | y-intercept | “r” | Range of Values |
| 109 | 0.97 | 1.6 | 0.983 | 12 – 396 U/L |
A study was performed where results obtained from testing whole blood samples (both venous and fingerstick) on the LDX were compared to results obtained from testing matched serum samples on the LDX. The comparative data appear below (serum results on x-axis).
| LDX AST: venous whole blood samples vs serum samples | ||||
|---|---|---|---|---|
| n | slope | y-intercept | "r" | Range of Values |
|---|---|---|---|---|
| 46 | 1.08 | 0.3 | 0.998 | 13 - 343 U/L |
LDX AST: fingerstick whole blood samples vs serum samples
| n | slope | y-intercept | "r" | Range of Values |
|---|---|---|---|---|
| 21 | 0.86 | 4.4 | 0.934 | 13 - 65 U/L |
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the figure.
SEP - 5 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Thomas E. Worthy, Ph.D. Vice President, Research and Regulatory Affairs Cholestech Corporation 3347 Investment Boulevard Hayward, CA 94545
K032027 -Re:
Trade/Device Name: Cholestech LDX aspartate aminotransferase (AST) Test Regulation Number: 21 CFR § 862.1100 Regulation Name: Aspartate amino transferase (AST/SGOT) Test System Regulatory Class: II Product Code: CIS Dated: June 30, 2003 Received: July 1, 2003
Dear Dr. Worthy
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
5
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(K) Number (if known):
Device Name: Cholestech LDX aspartate aminotransferase (AST) Test
Indications for Use:
The Cholestech LDX aspartate aminotransferase (AST) test is for the in vitro quantitative determination of AST in whole blood or serum on the Cholestech LDX Analyzer.
AST measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis), and heart diseases.
Carol C Benson for Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032027
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE AS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use * (Per 21 CFR 801.109)
OR
Over -the-Counter Use ________________________________________________________________________________________________________________________________________________________