CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772

K991834 · Cholestech Corp. · CKD · Sep 9, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991834
• Device Name: CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772
• Applicant: Cholestech Corp.
• Product Code: CKD · Clinical Chemistry
• Decision Date: Sep 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1030
• Device Class: Class 1

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.

Device Story

The Cholestech L·D·X ALT Test is an enzymatic, solid-phase diagnostic assay used with the Cholestech L·D·X Analyzer. Input consists of fingerstick whole blood (collected in lithium heparin capillary tubes) or venous whole blood/serum. The cassette separates plasma from blood cells; plasma migrates to an ALT reaction pad. The enzymatic process involves L-Alanine and α-Ketoglutarate conversion to pyruvate and glutamate, followed by pyruvate oxidation to produce hydrogen peroxide. Horseradish peroxidase catalyzes a reaction with an indicator dye, forming a blue color proportional to ALT concentration. The analyzer uses reflectance photometry to measure color intensity. Calibration data is provided via a magnetic stripe on each cassette. The device is intended for use in clinical laboratories and point-of-care settings by healthcare professionals. Results assist clinicians in diagnosing and monitoring liver and heart conditions.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (within-run and total precision) and method comparison studies against the predicate device. Method comparison using capillary whole blood (n=24, r=0.932), venous whole blood (n=53, r=0.975), and serum (n=52, r=0.971) demonstrated strong correlation. Interference testing confirmed no significant interference from uric acid (15 mg/dL), bilirubin (5 mg/dL), hematocrit (up to 50%), or lipemia (450 mg/dL triglycerides).

Technological Characteristics

Solid-phase enzymatic assay; reflectance photometry. Materials include lithium heparin coated capillary tubes and reaction pads. Connectivity via magnetic stripe calibration. Operates at 37°C. No specific ASTM standards cited.

Indications for Use

Indicated for in vitro quantitative determination of ALT in whole blood or serum to aid in the diagnosis and treatment of liver diseases (e.g., viral hepatitis, cirrhosis) and heart diseases.

Regulatory Classification

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.

Predicate Devices

• Roche Diagnostics Reflotron GPT (ALT) test (K864082)

Submission Summary (Full Text)

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9 1999 SEP

K991834

# 510(k) Summary

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. | | | |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|------------------------------|--|
| 1.<br>Submitter<br>name, address,<br>contact | Cholestech Corporation<br>3347 Investment Blvd.<br>Hayward, CA 94545-3808<br>[phone]<br>Fax: [phone] | | | |
| | Contact Person: Thomas Worthy<br>Date Prepared: 26 May 1999 | | | |
| 2.<br>Device name | Proprietary name: Cholestech L·D·X Alanine aminotransferase (ALT) Test<br>Common name: Colorimetric assay for the determination of alanine<br>aminotransferase.<br>Classification name: Alanine aminotransferase (ALT/SGPT) test system | | | |
| 3.<br>Predicate<br>Device | The Cholestech L·D·X Alanine aminotransferase Test is substantially<br>equivalent to other products in commercial distribution intended for similar<br>use. Most notably it is substantially equivalent to the currently marketed<br>Roche Diagnostics Reflotron GPT (ALT) test. | | | |
| 4.Device<br>Description | The Cholestech L·D·X Alanine Aminotransferase Test (ALT) combines an<br>enzymatic methodology and a solid-phase technology to measure ALT in<br>whole blood or serum. Blood from a fingerstick is collected into a lithium<br>heparin coated capillary tube (venous whole blood serum is also acceptable)<br>and dispensed into a L·D·X cassette. The cassette is then placed into the<br>Cholestech L·D·X where a unique system separates the plasma from the blood<br>cells. The plasma flows to both sides of the cassette and is transferred to the<br>ALT reaction pad. | | | |
| 4.Device<br>Description,<br>cont. | The Cholestech L•D•X Analyzer measures alanine aminotransferase by an<br>enzymatic method based on the method formulation of Katsuyama et al.<br>Alanine aminotransferase catalyzes the transfer of amino groups from L-<br>Alanine and α-Ketoglutarate to pyruvate and glutamate. Pyruvate oxidase, in<br>the presence of oxygen, oxidizes the pyruvate to acetylphosphate and<br>hydrogen peroxide. In a reaction catalyzed by horseradish peroxidase, the<br>peroxide reacts with an indicator dye to form a blue color at a rate<br>proportional to the ALT concentration of the sample. The resultant color in<br>the reaction is measured by reflectance photometry. | | | |
| | L-Alanine + α -Ketoglutarate<br> | Alanine Aminotransferase<br>→ | Pyruvate + Glutamate | |
| | Pyruvate + Phosphate + O2 + H2O | Pyruvate Oxidase<br>→ | Acetylphosphate + CO2 + H2O2 | |
| | Indicator + H2O2 | Peroxidase<br>→ | Colored Blue Dye + H2O | |
| | A brown magnetic stripe on each cassette contains the calibration information<br>required for the Cholestech L•D•X Analyzer to convert the reflectance<br>reading to the ALT concentration in U/L at 37° C. | | | |
| 5.<br>Intended use | The Cholestech L•D•X Alanine aminotransferase (ALT) Test is for the in vitro<br>quantitative determination of alanine aminotransferase (ALT) in whole blood<br>or serum on the Cholestech L•D•X Analyzer | | | |
| 6.<br>Comparison to<br>predicate<br>device | The Cholestech L•D•X Alanine aminotransferase Test is substantially<br>equivalent to other products in commercial distribution intended for similar<br>use. Most notably it is substantially equivalent to the currently marketed<br>Roche Diagnostics Reflotron GPT (ALT) test (K864082). | | | |

continued on next page

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6. 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<br>required | L·D·X Analyzer | Reflotron System |
| Assay Range | 10-400 U/L | 5 - 1200 U/L |
| Sample Type | Whole blood (capillary and<br>venous) and serum | Whole blood (capillary and<br>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<br>Comparison | Vs Reflotron GPT (ALT): | Vs GPT (ALT) IFCC Method: |
| | x = Capillary Whole Blood<br>y = Capillary Whole Blood<br>n = 24<br>y = $0.921x + 4.28$ ; r = 0.932 | x = Venous Heparin Blood<br>y = Heparin Plasma<br>n = 69<br>y = $1.02x - 3.6$ ; r = 0.995 |
| | x = Venous Whole Blood<br>y = Venous Whole Blood<br>n = 53<br>y = $0.916x + 0.269$ ; r = 0.975 | x = Serum<br>y = Serum<br>n = 36<br>y = $1.01x + 0.2$ ; r = 0.999 |
| | x = Serum<br>y = Serum<br>n = 52<br>y = $0.914x - .517$ ; r = 0.971 | x = Venous Heparin Plasma<br>y = Venous Heparin Plasma<br>n = 69<br>y = $1.04x - 3.3$ ; r = 0.993 |
| | | x = Capillary Heparin Blood<br>y = Capillary Heparin Plasma<br>n = 26<br>y = $0.969x + 4.7$ ; r = 0.994 |

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6.

### Performance Characteristics:

Comparison to predicate device cont.

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6.

Performance Characteristics, cont.:

Comparison to predicate device, (cont.)

| Feature | L-D-X ALT | Reflotron GPT (ALT) |
|---------------------------|-------------------------|--------------------------------------------------------|
| Interfering<br>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),<br>1700 mg/dL (triglycerides) |

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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.

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#### 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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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) |
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| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
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(Optional Format 1-2-96)