(104 days)
Not Found
No
The description details a chemical and enzymatic reaction measured by reflectance photometry, with calibration information stored on a magnetic stripe. There is no mention of AI or ML algorithms being used for analysis or interpretation.
No
The device is an in vitro diagnostic device used for quantitative determination of alanine aminotransferase (ALT) for diagnostic purposes, not for therapeutic intervention.
Yes
The device quantitatively determines alanine aminotransferase (ALT) levels, which are "used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases." This direct use of the measurement for diagnostic purposes classifies it as a diagnostic device.
No
The device description clearly outlines a physical cassette, a capillary tube for blood collection, and an analyzer that performs enzymatic reactions and reflectance photometry. This involves significant hardware components and chemical processes, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the test is "for the in vitro quantitative determination of alanine aminotransferase (ALT) in whole blood or serum". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Sample Type: The device analyzes biological samples (whole blood or serum) taken from the human body.
- Purpose: The results of the test are used "in the diagnosis and treatment of certain liver diseases... and heart diseases." This indicates a medical purpose for the test results.
- Device Description: The description details a process of analyzing the sample using chemical reactions and a measurement system, which is typical of IVD devices.
Therefore, based on the provided information, the Cholestech L·D·X Alanine aminotransferase Test (ALT) clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cholestech L·D·X Alanine aminotransferase (ALT) Test is for the in vitro quantitative determination of alanine aminotransferase (ALT) in whole blood or serum on the Cholestech L.D.X Analyzer.
Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
Product codes (comma separated list FDA assigned to the subject device)
CKD
Device Description
The Cholestech L·D·X Alanine Aminotransferase Test (ALT) combines an enzymatic methodology and a solid-phase technology to measure ALT in whole blood or serum. Blood from a fingerstick is collected into a lithium heparin coated capillary tube (venous whole blood serum is also acceptable) and dispensed into a L·D·X cassette. The cassette is then placed into the Cholestech L·D·X where a unique system separates the plasma from the blood cells. The plasma flows to both sides of the cassette and is transferred to the ALT reaction pad.
The Cholestech L•D•X Analyzer measures alanine aminotransferase by an enzymatic method based on the method formulation of Katsuyama et al. Alanine aminotransferase catalyzes the transfer of amino groups from L-Alanine and α-Ketoglutarate to pyruvate and glutamate. 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 ALT concentration of the sample. The resultant color in the reaction is measured by reflectance photometry.
L-Alanine + α -Ketoglutarate Alanine Aminotransferase → Pyruvate + Glutamate
Pyruvate + Phosphate + O2 + H2O Pyruvate Oxidase → Acetylphosphate + CO2 + H2O2
Indicator + H2O2 Peroxidase → Colored Blue Dye + H2O
A brown magnetic stripe on each cassette contains the calibration information required for the Cholestech L•D•X Analyzer to convert the reflectance reading to the ALT concentration in U/L at 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
Clinical laboratories and 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision (NCCLS modified):
- Within run (U/L):
- Level 1: N=20, Mean=30.6, SD=0.97, %CV=3.2
- Level 2: N=20, Mean=57.8, SD=1.80, %CV=3.1
- Serum Pool: N=20, Mean=168.9, SD=5.68, %CV=3.4
- Total (U/L):
- Level 1: N=20, Mean=30.6, SD=1.67, %CV=5.4
- Level 2: N=20, Mean=57.8, SD=2.68, %CV=4.6
- Serum Pool: N=20, Mean=168.9, SD=11.02, %CV=6.5
Method Comparison (Vs Reflotron GPT (ALT)):
- x = Capillary Whole Blood, y = Capillary Whole Blood, n = 24, y = 0.921x + 4.28 ; r = 0.932
- x = Venous Whole Blood, y = Venous Whole Blood, n = 53, y = 0.916x + 0.269 ; r = 0.975
- x = Serum, y = Serum, n = 52, y = 0.914x - 0.517 ; r = 0.971
Interfering substances (No interference at):
- Uric Acid: 15 mg/dl
- Bilirubin: 5 mg/dL
- Hematocrit: 50%
- Lipemia: 450 mg/dL triglycerides
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Assay Range: 10-400 U/L
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.
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.
Not Found
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).
Not Found
§ 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.
0
9 1999 SEP
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. | | | |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|------------------------------|--|
| 1.
Submitter
name, address,
contact | Cholestech Corporation
3347 Investment Blvd.
Hayward, CA 94545-3808
(510) 293-8002
Fax: (510) 732-7227 | | | |
| | Contact Person: Thomas Worthy
Date Prepared: 26 May 1999 | | | |
| 2.
Device name | Proprietary name: Cholestech L·D·X Alanine aminotransferase (ALT) Test
Common name: Colorimetric assay for the determination of alanine
aminotransferase.
Classification name: Alanine aminotransferase (ALT/SGPT) test system | | | |
| 3.
Predicate
Device | The Cholestech L·D·X Alanine aminotransferase Test is substantially
equivalent to other products in commercial distribution intended for similar
use. Most notably it is substantially equivalent to the currently marketed
Roche Diagnostics Reflotron GPT (ALT) test. | | | |
| 4.Device
Description | The Cholestech L·D·X Alanine Aminotransferase Test (ALT) combines an
enzymatic methodology and a solid-phase technology to measure ALT in
whole blood or serum. Blood from a fingerstick is collected into a lithium
heparin coated capillary tube (venous whole blood serum is also acceptable)
and dispensed into a L·D·X cassette. The cassette is then placed into the
Cholestech L·D·X where a unique system separates the plasma from the blood
cells. The plasma flows to both sides of the cassette and is transferred to the
ALT reaction pad. | | | |
| 4.Device
Description,
cont. | The Cholestech L•D•X Analyzer measures alanine aminotransferase by an
enzymatic method based on the method formulation of Katsuyama et al.
Alanine aminotransferase catalyzes the transfer of amino groups from L-
Alanine and α-Ketoglutarate to pyruvate and glutamate. 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 ALT concentration of the sample. The resultant color in
the reaction is measured by reflectance photometry. | | | |
| | L-Alanine + α -Ketoglutarate
| Alanine Aminotransferase
→ | Pyruvate + Glutamate | |
| | Pyruvate + Phosphate + O2 + H2O | Pyruvate Oxidase
→ | Acetylphosphate + CO2 + H2O2 | |
| | Indicator + H2O2 | Peroxidase
→ | Colored Blue Dye + H2O | |
| | A brown magnetic stripe on each cassette contains the calibration information
required for the Cholestech L•D•X Analyzer to convert the reflectance
reading to the ALT concentration in U/L at 37° C. | | | |
| 5.
Intended use | The Cholestech L•D•X Alanine aminotransferase (ALT) Test is for the in vitro
quantitative determination of alanine aminotransferase (ALT) in whole blood
or serum on the Cholestech L•D•X Analyzer | | | |
| 6.
Comparison to
predicate
device | The Cholestech L•D•X Alanine aminotransferase Test is substantially
equivalent to other products in commercial distribution intended for similar
use. Most notably it is substantially equivalent to the currently marketed
Roche Diagnostics Reflotron GPT (ALT) test (K864082). | | | |
continued on next page
1
2
- Comparison to predicate device, cont.
The following table compares the Cholestech L·D·X Alanine aminotransferase Test with the predicate device, Roche Diagnostics Reflotron GPT (ALT) test. Specific data on the performance of the test have been incorporated into the draft labeling in Section 5. Labeling for the predicate device is provided in Section 6.
Similarities:
·Intended Use: Colorimetric assay for the in vitro quantitative determination of alanine aminotransferase (glutamate pyruvate transaminase).
· Testing Sites: Clinical laboratories and point of care
· Test principle: Pyruvate oxidase and peroxidase catalyzed reactions
Differences:
| Feature | L.D.X ALT | Reflotron GPT (ALT) |
|---|---|---|
| Instrument | ||
| required | L·D·X Analyzer | Reflotron System |
| Assay Range | 10-400 U/L | 5 - 1200 U/L |
| Sample Type | Whole blood (capillary and | |
| venous) and serum | Whole blood (capillary and | |
| venous), serum and plasma | ||
| Feature | L-D-X ALT | Reflotron GPT (ALT) |
| Precision | NCCLS (modified): | (From Reflotron Package Insert) |
| Within run (U/L) | Within run (U/L) | |
| Level 1 Level 2 Serum Pool | Level I Level II Pool | |
| N | 20 20 20 | 20 20 20 |
| Mean | 30.6 57.8 168.9 | 51.0 110 166 |
| SD | 0.97 1.80 5.68 | 1.01 3.0 5.1 |
| %CV | 3.2 3.1 3.4 | 2.0 2.7 3.1 |
| Total (U/L): | Day to Day Precision (U/L): | |
| Level 1 Level 2 Serum Pool | Level I Level II | |
| N | 20 20 20 | 15 15 |
| Mean | 30.6 57.8 168.9 | 54.8 116.9 |
| SD | 1.67 2.68 11.02 | 1.7 4.2 |
| %CV | 5.4 4.6 6.5 | 3.1 3.6 |
| Method | ||
| Comparison | Vs Reflotron GPT (ALT): | Vs GPT (ALT) IFCC Method: |
| x = Capillary Whole Blood | ||
| y = Capillary Whole Blood | ||
| n = 24 | ||
| y = $0.921x + 4.28$ ; r = 0.932 | x = Venous Heparin Blood | |
| y = Heparin Plasma | ||
| n = 69 | ||
| y = $1.02x - 3.6$ ; r = 0.995 | ||
| x = Venous Whole Blood | ||
| y = Venous Whole Blood | ||
| n = 53 | ||
| y = $0.916x + 0.269$ ; r = 0.975 | x = Serum | |
| y = Serum | ||
| n = 36 | ||
| y = $1.01x + 0.2$ ; r = 0.999 | ||
| x = Serum | ||
| y = Serum | ||
| n = 52 | ||
| y = $0.914x - .517$ ; r = 0.971 | x = Venous Heparin Plasma | |
| y = Venous Heparin Plasma | ||
| n = 69 | ||
| y = $1.04x - 3.3$ ; r = 0.993 | ||
| x = Capillary Heparin Blood | ||
| y = Capillary Heparin Plasma | ||
| n = 26 | ||
| y = $0.969x + 4.7$ ; r = 0.994 |
3
Performance Characteristics:
Comparison to predicate device cont.
Continued on next page
4
Performance Characteristics, cont.:
Comparison to predicate device, (cont.)
| Feature | L-D-X ALT | Reflotron GPT (ALT) |
|---|---|---|
| Interfering | ||
| substances | No interference at: | No interference at: |
| Uric Acid | 15 mg/dl | Not reported |
| Bilirubin | 5 mg/dL | Not reported |
| Hematocrit | 50% | 55% |
| Lipemia | 450 mg/dL triglycerides | 400 mg/dL (cholesterol), |
| 1700 mg/dL (triglycerides) |
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
19 1999 SEP
Thomas E. Worthy, Ph.D. Director, Technical Affairs Cholestech Corporation 3347 Investment Blvd. Hayward, California 94545-3808
Re: K991834
Trade Name: Cholestech L·D·X Alanine Aminotransferase (ALT) Test Regulatory Class: I Product Code: CKD Dated: July 23, 1999 Received: July 26, 1999
Dear Dr. Worthy:
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.
6
Page 2
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 Butman
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
7
510(k) Number (if known): N/A K991834
Device Name: Cholestech L·D·X Alanine aminotransferase Test (ALT)
Indications For Use:
The Cholestech L·D·X Alanine aminotransferase Test (ALT) is for the in vitro quantitative determination of alanine aminotransferase (ALT) in whole blood or serum on the Cholestech L.D.X Analyzer.
Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
Jeans Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices 9910 11 510(k) Number_
| 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)