CARESIDE ALT

K020487 · Careside, Inc. · CKA · Jun 4, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020487
• Device Name: CARESIDE ALT
• Applicant: Careside, Inc.
• Product Code: CKA · Clinical Chemistry
• Decision Date: Jun 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1030
• Device Class: Class 1

Intended Use

The CARESIDE® ALT cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE® Analyzer to quantitatively measure ALT activity in anti-coagulated whole blood, plasma, or serum.

Device Story

The CARESIDE ALT system is a point-of-care diagnostic device for quantitative measurement of ALT activity in anti-coagulated whole blood, plasma, or serum. The system consists of a single-use disposable cartridge containing a multi-layer reagent film and the CARESIDE Analyzer. The user introduces the specimen into the cartridge, which is then inserted into the analyzer. The analyzer automatically scans the barcode, heats the cartridge to 37°C, and spins it to distribute the sample. ALT in the specimen catalyzes a reaction sequence producing hydrogen peroxide, which oxidizes a leuco dye to form a green dye. A photodiode measures the rate of change in reflected light intensity at 655 nm. The analyzer uses these reflectance measurements and a lot-specific standard curve to calculate ALT activity. Results are provided to the clinician to aid in the diagnosis and treatment of liver and heart disease.

Clinical Evidence

Bench testing only. Performance evaluated via method comparison against a BM/Hitachi 902 analyzer (n=not specified, r=1.00, slope=0.98). Precision reported as total CV of 4.5% at 22 U/L. Accuracy demonstrated with mean recovery of 106%. Interference testing showed no significant impact from ascorbic acid (10 mg/dL), bilirubin (20 mg/dL), triglycerides (3000 mg/dL), or gamma globulin (4200 mg/dL).

Technological Characteristics

Dry film-based enzymatic assay. Reagents: L-alanine, α-ketoglutaric acid, phosphoric acid, pyruvate oxidase, peroxidase, diarylimidazole leuco dye. Sensing: Reflectance photometry at 655 nm. Energy: 37°C thermal control. Connectivity: Barcode-based lot-specific calibration. Form factor: Single-use disposable cartridge. Software: Automated processing of reflectance measurements.

Indications for Use

Indicated for in vitro diagnostic use with the CARESIDE Analyzer to quantitatively measure ALT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of patients with certain types of liver and heart disease.

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

• Vitros ALT DT Slides for Johnson and Johnson's Vitros DT 60 (K912844/A)

Submission Summary (Full Text)

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(020487)

CARESIDE ALT Premarket Notificatio April 30, 2002

### 510(K) SUMMARY: CARESIDE® ALT SAFETY AND IV. EFFECTIVENESS

#### I. Applicant Information

- Applicant Name A.
- Applicant/Manufacturer B. Address
- Telephone Number C.
- Contact Person D.
- FAX Number E.
- e-Mail Address F.
- G. Date 510(k) Summary prepared

#### II. Device Information

- A. Device Name (Trade)
- Device Name B. (Classification)

#### C. Device Classification

CARESIDE, Inc. 6100 Bristol Parkway Culver City, CA 90230 310-338-6767 Renate A. MacLaren, Ph.D. 310-670-6986 [e-mail] April 30, 2002

### CARESIDE® ALT ALT test system

Clinical chemistry panel ALT test system Regulation Number: 21 CFR 862.1030 Regulatory Class I Classification Number: to be assigned None applicable

- Special controls and D. performance standards
#### III. Substantial Equivalence Claim

- General equivalency claim A.
The ability to monitor analyte-specific biochemical reactions in dry film and other formats is widely recognized and has gained widespread acceptance for use in chemistry assays. ALT in vitro diagnostic products, in both dry film and other formats, are already on the U.S. market.

#### B. Specific equivalency claim

The CARESIDE ALT test is substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantitative measurement of ALT on the Vitros DT 60 II.

Name of Predicate Device: Johnson and Johnson's (formerly Eastman Kodak, Inc.) Vitros ALT DT Slides for Johnson and Johnson's Vitros DT 60 (formerly Eastman Kodak's DT 60 II).

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| Predicate Device 510K number: | K912844/A |
|-------------------------------|-----------|
| Product Code: | 75CKA |

#### IV. Device Description

CARESIDE ALT cartridges are used with the CARESIDE, Inc. CARESIDE Analyzer to measure ALT activity in anti-coagulated whole blood, plasma, or serum specimens. The CARESIDE® ALT cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of sample to a dry film to initiate the measurement of ALT activity. The patented film cartridge contains all reagents necessary to measure ALT activity.

#### A. Explanation of Device Function

Each CARESIDE ALT cartridge consists of an ALT-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the specimen into the cartridge sample well, closes the lid and inserts the cartridge into the CARESIDE Analyzer.

Once loaded, the CARESIDE Analyzer scans the cartridge barcode, brings the cartridge and the contained specimen to 37℃, and spins the cartridge to move the sample from the sample well into the cartridge channels and chambers. Approximately 8.5 microliters of sample remains in the metering passage. Any excess sample flows into an overflow well.

The sample is automatically dispensed onto the multi-layer reagent film. The spreading and substrate layer uniformly distributes the specimen. As the specimen passes through the spreading and substrate layer, ALT in the specimen catalyzes the reaction of L-aspartate and a-ketotglutaric acid to form pyruvic acid and L-glutamic acid (see Test Reaction Sequence). The pyruvic acid is converted to acetyl phosphoric acid, CO2 and hydrogen peroxide in the reaction layer. Peroxidase in the reaction layer then catalyzes the oxidation of a diaryliminidazole leuco dye by hydrogen peroxide to form a green dye. The rate of change of intensity of the color as measured by the amount of reflected light at 655 directly relates to the amount of ALT activity in the specimen.

### Test Reaction Sequence:

L-alanine + a-ketoglutaric acid - 415-

Pyruvic acid + L-glutamic acid

Pyruvic acid + O2 + phosphoric acid ->

H2O2 + CO2 + acetyl phosphoric acid

Diarylimidazole leuco dye + H2O2 - - Green dye + H2O

As the cartridges spin, a photodiode measures reflectance of light emitted by a wavelength-specific light emitting diode (LED) over a fixed time

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period. The analyzer uses the reflectance measurements and the lotspecific standard curve to calculate ALT activity.

- B. Test Summary
Alanine aminotransferase, formerly known as serum glutamate pyruvate transaminase (SGPT), is an enzyme involved in the metabolism of amino acids. It is found in numerous organs and tissues with the highest levels in the kidneys and liver. ALT is released into the bloodstream as a result of tissue damage and in a variety of diseases involving the liver, such as hepatitis, cirrhosis, and mononucleosis.

#### V. Intended Use

- A. Intended Use
The CARESIDE® ALT cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE® Analyzer to quantitatively measure ALT activity in anti-coagulated whole blood, plasma, or serum.

- B. Indications for Use
For in vitro diagnostic use with the CARESIDE Analyzer to quantitatively measure ALT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of patients with certain types of liver and heart disease.

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،

#### VI. Technological Characteristics

- A. Similarities

| | CARESIDE ALT | Vitros ALT DT Slides |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use. | For in vitro diagnostic use |
| Indications | Primarily to aid in the<br>diagnosis and treatment of<br>patients with certain types of<br>liver and heart disease. | Same |
| Measurement | Quantitative | Same |
| Method<br>Principle | Dry film based quantitation of<br>enzymatic activity by<br>reflectance photometry using<br>POP/POD coupling of ALT<br>catalyzed generation of<br>pyruvate | Dry film based. LDH<br>coupling of ALT catalyzed<br>generation of pyruvate. |
| Specimen<br>Dilution | Not required | Same |
| Materials | L-alanine, α-ketoglutaric<br>acid, phosphoric acid,<br>pyruvate oxidase, peroxidase<br>and diarylimidazole leuco<br>dye. | Lactate deydrogenase, L-<br>alanine, sodium α-<br>ketoglutarate, nicotinamide<br>adenine dinucleotide reduced,<br>and sodium pyridoxal-5-<br>phosphate. |
| Detector | Reflectance (655 nm) | Reflectance (340 nm) |
| Test Time | Approx. 4-minute warm-up<br>(on-board) plus 4 minute test<br>time. | 15 minutes slide warm-up<br>(off-line) plus 5 minutes test<br>time. |
| Reference<br>Method | NADH/NAD coupled<br>reduction of pyruvate by<br>lactate dehydrogenase | IFCC, 1978 |
| Sample Type | Anti-coagulated whole blood,<br>plasma, or serum | Same |
| Specimen<br>Volume | 8.5µl test volume<br>(90 ± 10 µl applied volume) | 10 µl |
| Calibration | Calibration information bar-<br>coded on each cartridge.<br>Calibration information may<br>change with lot. | Run Vitros DT II calibrators<br>whenever a new slide lot is<br>used or when necessary. |
| Quality<br>Control | 2 levels | Same |
| Reporting<br>Units | U/L | Same |
| Reaction<br>Temp. | 37 °C | Same |
| | CARESIDE ALT | Vitros ALT DT Slides |
| Specimen<br>Pre-<br>treatment | Not Required | Same |
| Reportable<br>Range | 15 – 1000 U/L | 3 – 950 U/L |
| Accurate<br>Pipetting | Not required | Required |
| Reagent<br>Pre-<br>warming | Not required | Required |

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April 30, 2002

#### B. Differences

- C. Comparative Performance Characteristics

| | CARESIDE ALT | Vitros ALT DT Slides |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Detection<br>limit | 15 U/L | 3 U/L |
| Reportable<br>Range | 15 - 1000 U/L | 3 - 950 U/L |
| Accuracy | Mean recovery 106% | Not available |
| Precision | Total CV, 22 U/L, 4.5% | Total CV, 40 U/L, 9.5% |
| Method<br>Comparison | CARESIDE® = 0.98 (BM/Hitachi 902) + 4.75 U/L, r =<br>1.00 | |
| Linearity | Linearity by mixing yielded<br>slope and correlation<br>coefficient within acceptable<br>limits | Not available |
| Interference | No significant interference<br>observed at tested<br>concentration of interferent:<br>Ascorbic Acid, 10 mg/dL<br>Bilirubin, 20 mg/dL<br>Triglycerides 3000 mg/dL<br>Gamma globulin 4200 mg/dL | High gamma globulin |

#### D. Conclusion

The nonclinical and clinical data provided demonstrate that the CARESIDE ALT product is as safe, effective, and performs as well as or better than the legally marketed predicate device.

-

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them.

Re:

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Renate A. MacLauren, Ph.D. Clinical Affairs Manager Careside 6100 Bristol Parkway Culver City, CA 90230

JUN 0 4 2002

k020487 Trade/Device Name: Careside® ALT Regulation Number: 21 CFR 862.1030 Regulation Name: Alanine amino transferase (ALT/SGPT) test system Regulatory Class: Class I, reserved Product Code: CKA Dated: April 30, 2002 Received: May 2, 2002

Dear Dr. MacLauren:

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, 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 (PMA), 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 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/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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### CARESIDE ALT Premarket Notification January 30, 2002

January 30, 2002

# VI. INDICATIONS FOR USE

510(k) Number:

Device Name:

CARESIDE® ALT

KO20487

Indications for use: For in vitro diagnostic use with the CARESIDE Analyzer to quantitatively measure ALT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of patients with certain types of liver and heart disease

ean Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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)