PICCOLO TOTAL CHOLESTEROL TEST SYSTEM

K023642 · Abaxis, Inc. · CHH · Jan 24, 2003 · Clinical Chemistry

Device Facts

• Record ID: K023642
• Device Name: PICCOLO TOTAL CHOLESTEROL TEST SYSTEM
• Applicant: Abaxis, Inc.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Jan 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Intended Use

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

Device Story

Piccolo Total Cholesterol Test System utilizes a reagent disc to process heparinized whole blood, plasma, or serum samples. The disc separates blood cells from plasma, meters the sample and diluent, and delivers the mixture to reaction cuvettes containing reagent beads. An enzymatic endpoint reaction occurs at 37°C, monitored by the Piccolo Point-of-Care Chemistry Analyzer. The system is designed for professional use in clinical laboratories or point-of-care settings. The analyzer provides quantitative cholesterol results, which clinicians use to diagnose and manage lipid-related disorders. The system features factory-calibrated, bar-coded lot-specific data, eliminating the need for user-performed calibration.

Clinical Evidence

Performance validated through method comparison (n=174) against the predicate device, yielding a correlation coefficient (r) of 0.997 and a slope of 1.079. Precision studies (n=160) showed within-run CV of 1.3-1.5% and total CV of 2.2-2.6%. Linearity studies demonstrated an r of 0.999. Comparability between serum, heparinized plasma, and heparinized whole blood was established.

Technological Characteristics

System consists of a reagent disc and a point-of-care chemistry analyzer. Employs enzymatic endpoint reaction chemistry. Reagents are provided as dry beads within the disc, reconstituted by the analyzer using an integrated liquid diluent. Operates at 37°C. Calibration is managed via bar-coded, factory-calibrated lot-specific data. Sample volume is approximately 100 µL.

Indications for Use

Indicated for the quantitative determination of total cholesterol in heparinized whole blood, heparinized plasma, or serum to aid in the diagnosis and treatment of disorders involving excess blood cholesterol and lipid/lipoprotein disorders.

Regulatory Classification

Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Predicate Devices

• Cholesterol Assay-RA (K802743)

Submission Summary (Full Text)

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JAN 2 4 2003

3240 Whipple Road, Union City, CA 94587 Phone 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: _______________________________________________________________________________________________________________________________________________

## 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® Total Cholesterol Test System |

Classification Name: Total Cholesterol Test system 862.1175

#### 3. Identification 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 |
|-------------------------|-------------------|-----------------------------------------------------------|--------------------------|
| Cholesterol<br>Assay-RA | Bayer Diagnostics | K802743*<br>(Ames Sera-Pak<br>Cholesterol<br>Reagent Kit) | 12/10/80 |

Presumptive K number. NOTE: The predicate device is currently known as Bayer * Diagnostics Cholesterol Reagent. Since Bayer has undergone a series of mergers and other business transactions (e.g., Bayer, Technicon, Miles, Ames), the exact regulatory "lineage" is difficult to determine.

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#### Description of the Device: 4.

The Piccolo® Lipid Panel Reagent Disc (which contains the Piccolo® Total Cholesterol 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.

#### 5. Statement of Intended Use:

The Piccolo® Lipid Panel Reagent Disc (contains the Piccolo® Total Cholesterol Test System) use with the Piccolo® Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of total cholesterol in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-ofcare 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® Total Cholesterol Test System in comparison to the legally marketed predicate device.

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### Specification Comparison for Piccolo Total Cholesterol (CHOL) Test Table 1: System versus Bayer Cholesterol-RA Assay

| | Piccolo Cholesterol Assay on<br>Abaxis Point-of-Care<br>Chemistry Analyzer | Bayer Cholesterol-RA Assay on<br>Hitachi 917 Analyzer |
|-------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Intended Use | Quantitative analysis of<br>cholesterol | Quantitative analysis of<br>cholesterol |
| Methodology | Enzymatic endpoint reaction | Enzymatic endpoint reaction |
| Sample Type | Heparinized whole blood,<br>heparinized plasma, and<br>serum | Heparinized plasma and serum |
| Sensitivity | 0.00294 A per mg/dL or 0.113 A<br>per mmol/L; 20 mg/dL | 0.0012 A per mg/dL or 0.0462 A<br>per mmol/L |
| Reagents | Dry test-specific reagent beads<br>and liquid diluent; reconstitution<br>performed by analyzer | Dry reagents (reconstituted by user<br>prior to use) and 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 | 20 - 520 mg/dL | 0 - 500 mg/dL |
| Testing Environment | Professional use | Professional use |
| Sample Size | Approx 100 µL | 2.7 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® Total Cholesterol Test System.

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## Linearity:

## Table 2: Summary of Linearity

| | Total Cholesterol | |
|-----------------------------|-------------------|--|
| Slope | 0.989 | |
| Intercept | 19.7 | |
| Correlation Coefficient (r) | 0.999 | |

## Precision:

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

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

| | Within-Run<br>(n =160) | Total<br>(n =160) |
|---------------------------|------------------------|-------------------|
| Total Cholesterol (mg/dL) | | |
| Serum 1 | | |
| Mean | 223.7 | 223.7 |
| SD | 3.0 | 5.7 |
| %CV | 1.3 | 2.6 |
| Serum 2 | | |
| Mean | 202.2 | 202.2 |
| SD | 3.1 | 4.4 |
| %CV | 1.5 | 2.2 |

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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 total cholesterol.

## Method Comparison:

| Table 4: Method Comparison Data for Total Cholesterol Assayed on the Using the | | | | |
|---------------------------------------------------------------------------------|--|--|--|--|
| Abaxis Piccolo® CHOL Assay and the Bayer CHOL Assay | | | | |

| | Parameters | Statistics |
|--------------------------|------------------|------------|
| Piccolo CHOL Test System | n* | 174 |
| Bayer Cholesterol Assay | n* | 174 |
| Piccolo CHOL Test System | Mean | 202.0 |
| Bayer Cholesterol Assay | Mean | 203.1 |
| Piccolo CHOL Test System | Std. Dev. | 53.5 |
| Bayer Cholesterol Assay | Std. Dev. | 49.4 |
| Piccolo CHOL Test System | Range of Samples | 108 - 342 |
| Bayer Cholesterol Assay | Range of Samples | 115 - 342 |

| | Linear Regression | Deming Regression |
|----------------------------------|-------------------|-------------------|
| n* | 174 | 174 |
| Slope | 1.079 | 1.083 |
| Intercept | -17.1 | -17.9 |
| Correlation Coefficient (r) | 0.997 | 0.997 |
| Std. Error of the Estimate (SEE) | 4.5 | 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® Total Cholesterol 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 is a black and white seal for the Department of Health & Human Services - USA. The seal is circular 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 beneath them, possibly representing water or movement.

Food and Drug 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: k023642

Trade/Device Name: Piccolo® Total Cholesterol Test System Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: Class I Product Code: CHH 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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#### INDICATIONS FOR USE STATEMENT 12.0

# Indications for Use

| 510(k) Number (if known): | K023642 |
|---------------------------|---------|
|---------------------------|---------|

Piccolo® Total Cholesterol Test System Device Name:

# Intended Use:

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

## Indications for Use:

Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein disorders.

## (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)

Sam A. Dor Di Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K003242