PICCOLO TRIGLYCERIDES TEST SYSTEM

K023639 · Abaxis, Inc. · JGY · Jan 24, 2003 · Clinical Chemistry

Device Facts

• Record ID: K023639
• Device Name: PICCOLO TRIGLYCERIDES TEST SYSTEM
• Applicant: Abaxis, Inc.
• Product Code: JGY · Clinical Chemistry
• Decision Date: Jan 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1705
• Device Class: Class 1

Intended Use

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

Device Story

The Piccolo Triglycerides Test System is a reagent disc used with the Piccolo Point-of-Care Chemistry Analyzer. It processes heparinized whole blood, heparinized plasma, or serum samples. The disc separates plasma from blood cells, meters the sample and diluent, and mixes them with reagent beads to initiate an enzymatic endpoint reaction. The analyzer monitors the reaction at 37°C. Results are provided to healthcare professionals in clinical or point-of-care settings to assist in diagnosing and managing lipid metabolism disorders. The system uses factory-calibrated, lot-specific data provided via barcode.

Clinical Evidence

Bench testing only. Linearity study showed r=1.000. Precision study (n=160) reported CVs of 1.1-2.3% (within-run) and 1.5-2.6% (total). Method comparison against predicate (n=172) yielded a correlation coefficient of 0.999, slope of 0.983, and intercept of 8.2. Sample type comparability (serum, heparinized plasma, heparinized whole blood) was established.

Technological Characteristics

System consists of a reagent disc with dry test-specific reagent beads and liquid diluent. Employs enzymatic endpoint reaction chemistry. Operates at 37°C. Calibration is factory-set via barcode. Sample volume is approximately 100 µL. Designed for professional use in clinical or point-of-care environments.

Indications for Use

Indicated for the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, lipid metabolism diseases, or endocrine disorders.

Regulatory Classification

Identification

A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

Predicate Devices

• Triglycerides-RA Assay Run on a Hitachi 917 Clinical Chemistry Analyzer (K854152)

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] |

#### 2. Device Information:

Classification Class I Piccolo® Triglycerides Test System Trade Name:

Classification Name: Triglycerides Test system 862.1705

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

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

| Predicate Device | Manufacturer | 510(k) Number | Date of SE Determination |
|----------------------------------------------------------------------------------|-------------------|------------------------------------------------------------------------|--------------------------|
| Triglycerides-RA<br>Assay Run on a<br>Hitachi 917 Clinical<br>Chemistry Analyzer | Bayer Diagnostics | K854152*<br>(Technicon RA<br>Systems for<br>Triglycerides<br>Analysis) | 11/5/85 |

*Presumptive K number. NOTE: The predicate device is currently known as Bayer Diagnostics Triglyceride Reagent. Since Bayer has undergone a series of mergers and

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other business transactions (e.g., Bayer, Technicon, Miles, Ames), the exact regulatory "lineage" is difficult to determine.

#### Description of the Device: 4.

The Piccolo® Lipid Panel Reagent Disc (which contains the Piccolo® Triglycerides 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 The diluted plasma mixes with the reagent beads, initiating the disc perimeter. chemical reactions that are then monitored by the analvzer. Alternately, the disc mav also be used with serum.

#### 5. Statement of Intended Use:

The Piccolo® Libid Panel Reagent Disc (contains the Piccolo® Triglycerides Test System) use with the Piccolo® Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of triglycerides 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® Trialycerides Test System in comparison to the legally marketed predicate device.

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### Specification Comparison for Piccolo Triglycerides (TRIG) Test Table 1: System versus Bayer Triglycerides-RA Assay

| | Piccolo Triglycerides Assay on<br>Abaxis Point-of-Care<br>Chemistry Analyzer | Bayer Triglycerides-RA Assay<br>on Hitachi 917 Analyzer |
|-------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Intended Use | Quantitative analysis of<br>triglycerides | Quantitative analysis of<br>triglycerides |
| Methodology | Enzymatic endpoint reaction | Enzymatic endpoint reaction |
| Sample Type | Heparinized whole blood,<br>heparinized plasma, and<br>serum | Heparinized plasma and serum |
| Sensitivity | 3.82 mA per mg/dL or 0.338 A<br>per mmol/L; 20 mg/dL | 0.99 mA per mg/dL or 0.088 A per<br>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 - 500 mg/dL | 0 - 500 mg/dL |
| Testing Environment | Professional use | Professional use |
| Sample Size | Approx 100 µL | 2 pl |

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

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

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# Linearity:

# Table 2: Summary of Linearity

| | Triglycerides |
|-----------------------------|---------------|
| Slope | 1.000 |
| Intercept | 3.0 |
| Correlation Coefficient (r) | 1.000 |

## Precision:

Precision studies were designed to evaluate within-run and total precision of triglycerides 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 Triglycerides Assayed on the Piccolo® Point-of-Care Chemistry Analyzer

| | Within-Run<br>(n =160) | Total<br>(n =160) |
|-----------------------|------------------------|-------------------|
| Triglycerides (mg/dL) | | |
| Serum 1 | | |
| Mean | 206.8 | 206.8 |
| SD | 4.7 | 5.5 |
| %CV | 2.3 | 2.6 |
| Serum 2 | | |
| Mean | 163.7 | 163.7 |
| SD | 1.8 | 2.4 |
| %CV | 1.1 | 1.5 |

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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 triglycerides.

## Method Comparison:

| Table 4: Method Comparison Data for Triglycerides Assayed on the Using the |
|----------------------------------------------------------------------------|
| Abaxis Piccolo® TRIG Assay and the Bayer TRIG Assay |

| | Parameters | Statistics |
|---------------------------|------------------|------------|
| Piccolo TRIG Test System | n* | 172 |
| Bayer Triglycerides Assay | n* | 172 |
| Piccolo TRIG Test System | Mean | 162 |
| Bayer Triglycerides Assay | Mean | 156 |
| Piccolo TRIG Test System | Std. Dev. | 87.6 |
| Bayer Triglycerides Assay | Std. Dev. | 89.0 |
| Piccolo TRIG Test System | Range of Samples | 46 - 488 |
| Bayer Triglycerides Assay | Range of Samples | 38 - 487 |

| | Linear Regression | Deming Regression |
|----------------------------------|-------------------|-------------------|
| n* | 172 | 172 |
| Slope | 0.983 | 0.984 |
| Intercept | 8.2 | 8.1 |
| Correlation Coefficient (r) | 0.999 | 0.999 |
| Std. Error of the Estimate (SEE) | 4.4 | 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® Triglycerides 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 logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines that suggest the head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

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: k023639

Trade/Device Name: Piccolo Triglycerides Test System Regulation Number: 21 CFR 862.1705 Regulation Name: Triglyceride test system Regulatory Class: Class I Product Code: JGY 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

K0236334 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Piccolo® Triglycerides Test System Device Name:

### Intended Use:

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

## Indications for Use:

Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

| Prescription Use | <div style="display:flex; align-items:center;">✓</div> | OR | Over- The Counter Use |
|----------------------|--------------------------------------------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |

(Division Sign-Off)

Division of Clinical Laboratory Devices

| 510(k) Number | K023639 |
|---------------|---------|
|---------------|---------|

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