CARESIDE GGT

K020486 · Careside, Inc. · JPZ · Jul 1, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020486
• Device Name: CARESIDE GGT
• Applicant: Careside, Inc.
• Product Code: JPZ · Clinical Chemistry
• Decision Date: Jul 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1360
• Device Class: Class 1

Intended Use

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

Device Story

CARESIDE GGT is a single-use disposable cartridge used with the CARESIDE Analyzer to measure GGT activity in anti-coagulated whole blood, plasma, or serum. The user applies the specimen to the cartridge, which contains a multi-layer reagent film. The analyzer heats the cartridge to 37°C and spins it to separate blood cells from plasma/serum. Plasma is automatically metered onto the reagent film, where GGT reacts with L-y-glutamyl-p-nitroanilide to produce p-nitroaniline. This reaction causes a color change measured by reflectance photometry at 425 nm. The analyzer uses the rate of color change and a lot-specific standard curve to calculate GGT activity. Results are used by clinicians to aid in diagnosing and treating liver diseases, including alcoholic cirrhosis and liver tumors. The device enables point-of-care testing by eliminating the need for manual sample separation and pipetting.

Clinical Evidence

Bench testing only. Performance data includes method comparison against the BM/Hitachi 902 GGT (r=1.00, slope 1.00, intercept 0.91 U/L). Precision testing showed a total CV of 2.6% at 344 U/L. Interference testing confirmed no significant impact from ascorbic acid (10 mg/dL), bilirubin (10 mg/dL), or triglycerides (3000 mg/dL). Reportable range is 20 to 1000 U/L.

Technological Characteristics

Dry film reagent cartridge containing L-y-glutamyl-p-nitroanilide and glycylglycine. Sensing via reflectance photometry at 425 nm. Operates at 37°C. Connectivity via barcode scanning on cartridges for lot-specific calibration. Standalone system.

Indications for Use

Indicated for in vitro diagnostic use with the CARESIDE Analyzer to quantitatively measure GGT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

Regulatory Classification

Identification

A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

Predicate Devices

• Vitros GGT Slides for Johnson and Johnson's Vitros DTSC 60 (K912844/A)

Reference Devices

• BM/Hitachi 902 GGT

Submission Summary (Full Text)

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CARESIDE, Inc. Page 1

CARESIDE GGT Premarket Notification 1 2002 JUL

May 10, 2002

K020486

# 510(K) SUMMARY: CARESIDE® GGT SAFETY AND EFFECTIVENESS

#### I. Applicant Information

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

#### II. Device Information

- A. Device Name (Trade)
- B. Device Name (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] May 10, 2002

CARESIDE® GGT

GGT test system Clinical chemistry panel GGT test system Regulation Number: 21 CFR 862.1360 Regulatory Class 1 (non-exempt for point of care use) Classification Number: 75JPZ None applicable

D. Special controls and performance standards

#### III. Substantial Equivalence Claim

#### A. General equivalency claim

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.

GGT in vitro diagnostic products, in both dry film and other formats, are currently marketed in the U.S., including GGT products which utilize GGT catalyzed generation of p-nitroaniline from the artificial substrate L-y-glutamyl-p-nitroanilide.

#### B. Specific equivalency claim

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

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

Predicate Device 510K number: K912844/A Product Code: 75JPZ

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#### IV. Device Description

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

#### A. Explanation of Device Function

Each CARESIDE® GGT cartridge consists of a GGT-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the anti-coagulated whole blood, serum. or plasma 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 deposition well into the cartridge channels and chambers. As the cartridge continues to spin, the blood cells are separated from the plasma/serum and the cells accumulate in the separation well. Approximately 8.5 microliters of plasma (or serum, as applicable) remain in the metering passage. Any excess sample flows into an overflow well.

The plasma (or serum, as applicable) is automatically dispensed onto the multi-layer reagent film. The spreading and substrate layer distributes the GGT containing specimen The GGT in the specimen reacts with the substrate L-y-glutamyl-puniformly. nitroanilide to release p-nitroaniline resulting in a change in film color. The rate of change of color intensity, as measured by the amount of reflected light at 425 nanometers, directly relates to the specimen GGT activity.

Test Reaction Sequence:

### L-Y-glutamyl-p-nitroanilide + glycylglycine

GGT ↓

### L-glutamylglycylglycine + p-nitroaniline

As the cartridges spin, photodiodes measure reflectance of light emitted by wavelengthspecific light emitting diodes (LEDs) over a fixed time period. The instrument uses the reflectance measurements and the lot-specific standard curve to calculate GGT activity.

#### B. Test Summary

y-Glutamyltransferase measurements are used in the diagnosis and treatment of liver diseases including alcoholic cirrhosis and primary and secondary liver tumors. GGT in the serum originates primarily from the hepatobiliary system even though renal tissue contains the highest levels of GGT. GGT is elevated in all forms of liver disease. GGT elevations are observed earlier and are more pronounced than those of other liver enzymes in cases of obstructive jaundice and metastatic neoplasms. In intra- or posthepatic biliary obstruction, GGT levels may reach levels 5 to 30 times higher than in intra- or post-hepatic biliary obstruction

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#### V. Intended Use

#### A. Intended Use

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

- Indications for Use B.
For in vitro diagnostic use with the CARESIDE Analyzer to quantitatively measure GGT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

#### Technological Characteristics VI.

- Similarities A.

| | CARESIDE® GGT | Vitros GGT DT Slides |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Intended Use | For in vitro Diagnostic use | Same |
| Indications | Primarily to aid in the<br>diagnosis and treatment of<br>patients with liver diseases<br>such as alcoholic cirrhosis and<br>primary and secondary liver<br>tumors. | Same |
| Measurement | Quantitative | Same |
| Method | Dry film based quantitation of | Same |
| Principle | enzymatic activity by<br>reflectance photometry using<br>L-g-glutamyl transferase and<br>glycylglycine substrate. | |
| Specimen | Not required | Same |
| Dilution | | |
| Materials | L-y-glutamyl-p-nitroanilide<br>and glycylglycine | L-y-glutamyl-p-nitroanilide<br>and glycylglycine |
| Detector | Reflectance (425 nm) | Reflectance (400 nm) |
| Test Time | Approx. 4 min. warm-up (on-<br>board) plus 5 minute test time. | 15 minutes slide warm-up (off-<br>line) plus 5 minutes test time. |
| Sample Type | Anti-coagulated whole blood,<br>serum or plasma [whole blood<br>applied sample, plasma test<br>sample] | Serum, plasma |
| Specimen | 8.5 µl test volume | 10 µl |
| Volume | (90 ± 10 µl applied volume) | |
| Calibration | Calibration information bar-<br>coded on each cartridge.<br>Calibration information may<br>change with each lot. | Run Vitros DTSC II<br>calibrators whenever a new<br>slide lot is used or when<br>necessary. |
| Quality Control | 2 levels | Same |
| Reporting Units | U/L | Same |
| Reaction Temp. | 37 °C | Same |

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#### B. Differences

| | CARESIDE® GGT | Vitros GGT DT Slides |
|--------------------------|------------------|--------------------------------------------------------------------------|
| Direct Blood<br>Specimen | Yes, whole blood | No, requires separation of<br>whole blood prior to<br>sample application |
| Reportable<br>range | 20 to 1000 U/L | 5 to 1400 U/L |
| Accurate<br>Pipetting | Not required | Required |
| Reagent Pre-<br>warming | Not required | Required |

#### C. Comparative Performance Characteristics

| | CARESIDE® GGT | Vitros GGT DT Slides |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Detection limit | 20 U/L | 5 U/L |
| Reportable<br>Range | 20 to 1000 U/L | 5 to 1400 U/L |
| Accuracy | Mean recovery 101% | Not available |
| Precision | Total CV, 344 U/L, 2.6% | Total CV, 166 U/L, 2.4% |
| Method<br>Comparison | CARESIDE = 1.00 (BM/Hitachi 902 GGT) + 0.91 U/L,<br>r= 1.00 | |
| Linearity | Linearity by dilution<br>yielded slope and<br>correlation coefficient<br>within acceptable limits. | Not available |
| Interference | No significant interference<br>observed at tested<br>concentration of<br>interferent:<br><br>Ascorbic Acid 10 mg/dL<br>Bilirubin 10 mg/dL<br>Triglycerides 3000 mg/dL | None stated |
| Specimen Types<br>&<br>Anticoagulants | No clinically significant<br>difference between sodium<br>heparinized whole blood,<br>serum, and sodium heparin<br>plasma. | No clinically significant<br>difference between serum,<br>heparin plasma, or EDTA<br>plasma. Whole blood is<br>unsuitable. |

#### D. Conclusion

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

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around it. Inside the circle is an abstract symbol that resembles three stylized human profiles or figures, possibly representing people or services provided by the department.

### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k020486 Trade/Device Name: Careside® GGT Regulation Number: 21 CFR 862.1360 Regulation Name: Gamma-glutamyl transpeptidase and isoenzymes test system Regulatory Class: Class I, reserved Product Code: JPZ Dated: May10, 2002 Received: May13, 2002

:

'JUL -

1 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. 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 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 (OS) 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/cdrh/dsmaldsmamain.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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K0204:86

# INDICATIONS FOR USE

510(k). Number:

Device Name:

· CARESIDE® GGT

For in vitro diagnostic use with the CARESIDE Analyzer to quantitatively Indications for use: measure GGT from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020486

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)