PICCOLO HDL TEST SYSTEM

K023640 · Abaxis, Inc. · LBS · Jan 24, 2003 · Clinical Chemistry

Device Facts

• Record ID: K023640
• Device Name: PICCOLO HDL TEST SYSTEM
• Applicant: Abaxis, Inc.
• Product Code: LBS · Clinical Chemistry
• Decision Date: Jan 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The Piccolo HDL Test System used with the Piccolo Point-of-Care Chemistry Analyzer is intended for the in vitro quantitative determination of HDL in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

Device Story

Piccolo HDL Test System uses reagent discs to process heparinized whole blood, plasma, or serum samples. Device separates plasma from blood cells via centrifugation within disc; meters plasma and diluent; mixes with reagent beads. Chemical reactions monitored by Piccolo Point-of-Care Chemistry Analyzer at 37°C. System provides quantitative HDL results for professional use in clinical labs or point-of-care settings. Output assists clinicians in diagnosing/treating lipid disorders, atherosclerosis, and liver/renal diseases. Factory-calibrated via barcode.

Clinical Evidence

Bench testing only. Linearity (r=0.997), within-run precision (CV 2.6-3.5%), and total precision (CV 3.5-4.3%) established. Method comparison against Roche HDL assay (n=166) showed correlation (r=0.965) with slope 0.851 and intercept 8.3. Sample type comparability (serum, heparinized plasma, heparinized whole blood) confirmed.

Technological Characteristics

Hybrid enzymatic colorimetric end-point assay; uses dextran/sulfate precipitation and PEG-modified enzymes. Dry reagent beads and liquid diluent; reconstitution performed by analyzer. Reaction temperature 37°C. Factory-calibrated via barcode. Assay range 15-100 mg/dL. Sample size ~100 µL.

Indications for Use

Indicated for in vitro quantitative determination of HDL in heparinized whole blood, heparinized plasma, or serum. Used in diagnosis and treatment of lipid disorders (e.g., diabetes mellitus), atherosclerosis, and liver/renal diseases.

Regulatory Classification

Identification

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Predicate Devices

• HDL-C plus (K902935)

Submission Summary (Full Text)

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JAN 2 4 2003

3240 Whipple Road, Union City, CA 94587 510 ● 675-6500 Fax 510 ● 441-6150

ABAXIS

This 510(k) summary of 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: K023640

### 1. Applicant Information:

| Date Prepared: | October 29, 2002 |
|-----------------|-------------------------------------------|
| Name: | Abaxis, Inc. |
| Address: | 3240 Whipple Road<br>Union City, CA 94587 |
| Contact Person: | Dennis M. Bleile, PhD |
| Phone Number: | [phone] |
| Fax Number: | [phone] |

#### Device Information: 2.

| Classification | Class I |
|----------------|--------------------------|
| Trade Name: | Piccolo® HDL Test System |

Classification Name: HDL Test system 862.1475

#### 3. ldentification of Legally Marketed Device to which the Submitter Claims Equivalence:

The following table identifies the legally marketed device to which Abaxis claims equivalence:

| Predicate Device | Manufacturer | 510(k) Number | Date of SE Determination |
|-------------------------------------------------------------------------------------|-------------------|---------------------------------------------------|--------------------------|
| HDL-C plus<br>(HDL assay) Run<br>on a Hitachi 917<br>Clinical Chemistry<br>Analyzer | Roche Diagnostics | K902935*<br>(Roche Cobas<br>Ready HDL<br>Reagent) | 9/27/90 |

* Presumptive K number. NOTE: The predicate device is currently known as HDL-C plus, for use on Hitachi instrumentation. Since Roche and Hitachi have a co-marketing agreement, it is assumed that this submission (for the Cobas) is the predicate.

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#### Description of the Device: 4.

The Piccolo® Lipid Panel Reagent Disc (which contains the Piccolo® HDL Test System) is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternately, the disc may also be used with serum.

#### ട. Statement of Intended Use:

The Piccolo® Lipid Panel Reagent Disc (contains the Piccolo® HDL Test System) use with the Piccolo® Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of HDL in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

#### 6. Summary of the Technological Characteristics of the New Device in Comparison to those of the Predicate Device:

Table 1 outlines the technological characteristics of the Piccolo® HDL Test System in comparison to the legally marketed predicate device.

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#### Specification Comparison for Piccolo HDL (HDL) Test Table 1: System versus Roche HDL-RA Assay

| | Piccolo HDL Assay on Abaxis<br>Point-of-Care Chemistry<br>Analyzer | Roche Diagnostics HDL-C plus<br>Assay on Hitachi 917 Analyzer |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative analysis of<br>HDL | Quantitative analysis of<br>HDL |
| Methodology | Hybrid enzymatic colorimetric end-<br>point test, making use of<br>dextran/sulfate precipitation,<br>centrifugation, and PEG-modified<br>enzymes | Homogeneous enzymatic<br>colorimetric end-point test, making<br>use of dextran/sulfate suspension<br>and PEG-modified enzymes |
| Sample Type | Heparinized whole blood,<br>heparinized plasma, and<br>serum | Heparinized plasma and serum |
| Sensitivity | 0.00799 A per mg/dL or 0.309 A<br>per mmol/L; 15 mg/dL | 3 mg/dL |
| Reagents | Dry test-specific reagent beads<br>and liquid diluent; reconstitution<br>performed by analyzer | Liquid reagents |
| Temperature of Reaction | 37°C | 37°C |
| Calibration | Bar code with factory<br>calibrated lot specific data | Calibrated periodically using<br>calibrators supplied by vendor |
| Assay Range | 15 - 100 mg/dL | 3 - 120 mg/dL |
| Testing Environment | Professional use | Professional use |
| Sample Size | Approx 100 µL | 3 µL |

#### 7. Brief Discussion of the Clinical and Nonclinical Tests Relied on for a Determination of Substantial Equivalence.

The following information summarizes the results of clinical and non-clinical tests performed using the Piccolo® HDL Test System.

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## Linearity:

### Table 2: Summary of Linearity

| | | HDL |
|-----------------------------|--|-------|
| Slope | | 0.983 |
| Intercept | | 0.5 |
| Correlation Coefficient (r) | | 0.997 |

### Precision:

Precision studies were designed to evaluate within-run and total precision of HDL included on the Piccolo® Lipid Panel Reagent Disc when run on the Piccolo® Pointof-Care Chemistry Analyzer.

### Table 3: Within-Run and Total Precision of HDL Assayed on the Piccolo® Point-of-Care Chemistry Analyzer

| | Within-Run<br>(n =160) | Total<br>(n =160) |
|-------------|------------------------|-------------------|
| HDL (mg/dL) | | |
| Serum 1 | | |
| Mean | 55.3 | 55.3 |
| SD | 1.4 | 1.9 |
| %CV | 2.6 | 3.5 |
| Serum 2 | | |
| Mean | 38.0 | 38.0 |
| SD | 1.3 | 1.6 |
| %CV | 3.5 | 4.3 |

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## Sample Type Comparison:

A study was conducted to examine and compare serum, heparinized plasma, and heparinized whole blood the Piccolo® Point-of-Care Chemistry Analyzer. The study included samples from 20 different patients. Each sample type was tested in quadruplicate. Serum, heparinized plasma and heparinized whole blood comparability was established for HDL.

#### Method Comparison:

## Table 4: Method Comparison Data for HDL Assayed on the Using the Abaxis Piccolo® HDL Assay and the Roche HDL Assay

| | Parameters | Statistics |
|--------------------------|------------------|------------|
| Piccolo CHOL Test System | n* | 166 |
| Roche HDL Assay | n* | 166 |
| Piccolo HDL Test System | Mean | 53.2 |
| Roche HDL Assay | Mean | 52.8 |
| Piccolo HDL Test System | Std. Dev. | 15.1 |
| Roche HDL Assay | Std. Dev. | 17.1 |
| Piccolo HDL Test System | Range of Samples | 25 - 90 |
| Roche HDL Assay | Range of Samples | 23 - 97 |

| | Linear Regression | Deming Regression |
|----------------------------------|-------------------|-------------------|
| n* | 166 | 166 |
| Slope | 0.851 | 0.877 |
| Intercept | 8.3 | 6.9 |
| Correlation Coefficient (r) | 0.965 | 0.965 |
| Std. Error of the Estimate (SEE) | 3.9 | N/A |

* n = all data points (patient samples were run in duplicate and both values were plotted; number of patient samples = n/2)

#### 8. Conclusions

The clinical and non-clinical tests performed using the Piccolo® HDL Test System. when run on the Piccolo® Point-of-Care Chemistry Analyzer, demonstrate that the test system is as safe, effective and performs as well as the legally marketed device identified above.

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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 a stylized symbol that resembles a caduceus, with three figures in profile facing right, representing health and human services.

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

JAN 2 4 2003

Dennis M. Bleile, Ph.D. Director of Assay Development Abaxis, Inc. 3240 Whipple Road Union City, CA 94587

Re: k023640 Trade/Device Name: Piccolo HDL Test System Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: LBS Dated: October 29, 2002 Received: October 30, 2002

Dear Dr. Bleile:

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 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 (QS) regulation (21 CFR Part 820).

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#### 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/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

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#### 12.0 INDICATIONS FOR USE STATEMENT

## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Piccolo® HDL Test System Device Name:

### Intended Use:

The Piccolo HDL Test System used with the Piccolo Point-of-Care Chemistry Analyzer is intended for the in vitro quantitative determination of HDL in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-ofcare location.

### Indications for Use:

Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div> <img alt="Prescription Use Tick" src="prescription_use_tick.png"/> </div> |
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OR

| Over- The Counter Use (Optional Format 1-2-96) | |
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| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | A023640 |