PICCOLO PHOSPHORUS TEST SYSTEM

K022312 · Abaxis, Inc. · CEO · Sep 5, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022312
• Device Name: PICCOLO PHOSPHORUS TEST SYSTEM
• Applicant: Abaxis, Inc.
• Product Code: CEO · Clinical Chemistry
• Decision Date: Sep 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1580
• Device Class: Class 1

Intended Use

The Piccolo Phosphorus Test System (presently contained on the Renal Function Panel Reagent disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of phosphorus in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

Device Story

Piccolo Phosphorus Test System uses reagent discs to process heparinized whole blood, plasma, or serum samples. Disc separates blood cells from plasma, meters required quantities, mixes with diluent and reagent beads, and delivers to reaction cuvettes. Analyzer monitors enzymatic endpoint reactions at 37°C. System provides quantitative phosphorus measurements for clinical laboratory or point-of-care use. Results assist clinicians in diagnosing and managing renal and metabolic conditions. Factory calibration via bar code simplifies operation. System offers rapid, automated analysis compared to traditional laboratory methods.

Clinical Evidence

Bench testing only. Linearity study showed correlation coefficient of 0.999 over 2-17 mg/dL range. Precision studies (n=80) demonstrated within-run CV of 1.3-3.7% and total CV of 2.0-4.7%. Comparability study established performance across heparinized whole blood, plasma, and serum.

Technological Characteristics

Dry reagent bead chemistry; enzymatic endpoint reaction; 37°C operating temperature; 100 µL sample volume; bar code factory calibration; standalone point-of-care analyzer; quantitative measurement range 0.2-20 mg/dL.

Indications for Use

Indicated for quantitative determination of phosphorus in human heparinized whole blood, heparinized plasma, or serum. Used in diagnosis and treatment of renal insufficiency, hypoparathyroidism, vitamin D imbalance, high calcium diet, hyperparathyroidism, and insulin treatment of diabetic ketoacidosis.

Regulatory Classification

Identification

A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

Predicate Devices

• Phosphorus Slides on the Vitros 950 Chemistry System (K932729)

Submission Summary (Full Text)

{0}------------------------------------------------

### 5 2002 SEP

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: K022312

### 1. Applicant Information:

| Date Prepared: | July 15, 2002 |
|-----------------|-------------------------------------------|
| Name: | Abaxis, Inc. |
| Address: | 3240 Whipple Road<br>Union City, CA 94587 |
| Contact Person: | Robert Milder |

| Contact Person: | Robert Milder |
|-----------------|----------------|
| Phone Number: | [phone] |
| Fax Number: | [phone] |

#### 2. Device Information:

Classification Class I Piccolo® Phosphorus Test System Trade Name:

Classification Name:

Phosphorus (Inorganic) Test system 862.1580

#### 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 | | | |
|------------------------------------------------------------|------------------------------------------------|------------------|-----------------------------|
| Predicate Device | Manufacturer | 510(k)<br>Number | Date of SE<br>Determination |
| Phosphorus Slides on<br>the Vitros 950<br>Chemistry System | Johnson and<br>Johnson Clinical<br>Diagnostics | K932729 | 8/3/93 |

{1}------------------------------------------------

# Summary of Safety and Effectiveness,

#### 4. Description of the Device:

The Piccolo Renal Function Panel Reagent Disc (which contains the Piccolo Phosphorus 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 Renal Function Panel Reagent Disc (contains the Piccolo Phosphorus Test System) use with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of phosphorus 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 Phosphorus Test System in comparison to the legally marketed predicate device.

| | Piccolo Point-of-Care Chemistry<br>Analyzer | Vitros 950 Chemistry<br>System |
|---------------------|----------------------------------------------------------|-----------------------------------------------------------------|
| Intended Use | Quantitative analysis of phosphorus | Quantitative analysis of phosphorus |
| Methodology | Enzymatic endpoint reaction | Colorimetric |
| Sample Type | Heparinized whole blood,<br>heparinized plasma and serum | Heparinized plasma, serum and urine |
| Sensitivity | 0.2 mg/dL | 0.5 mg/dL |
| Reagents | Dry test-specific reagent beads | p-Methylaminophenol sulfate and<br>ammonium molybdate |
| Temperature | 37°C | 37°C |
| Calibration | Bar code with factory<br>calibrated lot specific data | Calibrated periodically using<br>calibrators supplied by vendor |
| Assay Range | 0.2 - 20 mg/dL | 0.5 - 13.0 mg/dL |
| Testing Environment | Professional use | Professional use |
| Sample Size | 100 µL | 10 µL |

# Table 1: Specification Comparison: Piccolo Phosphorus Test System

{2}------------------------------------------------

# Summary of Safety and Effectiveness,

#### Brief discussion of the clinical and nonclinical tests relied on for a 7. determination of substantial equivalence.

Tables 2 summarize the results of clinical and non-clinical tests performed using the Piccolo® Phosphorus Test System.

Linearity:

| | Phosphorus |
|-------------------|--------------|
| Slope | 1.00 |
| Intercept | +0.2 |
| Corr. Coefficient | 0.999 |
| Sample Range | 2 - 17 mg/dL |

## Table 2: Summary of Linearity

## Precision:

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

## Table 3: Within-Run and Total Precision for Phosphorus, Assayed on the Piccolo Point-of-Care Chemistry Analyzer

| Analyte | Within-Run<br>(n = 80) | Total<br>(n = 80) |
|-------------------------------|------------------------|-------------------|
| Phosphorus (mg/dL)<br>Level 1 | | |
| Mean | 3.1 | 3.1 |
| SD | 0.12 | 0.14 |
| CV | 3.7 | 4.7 |
| Level 2 | | |
| Mean | 7.3 | 7.3 |
| SD | 0.09 | 0.15 |
| CV | 1.3 | 2.0 |

{3}------------------------------------------------

# Summary of Safety and Effectiveness,

## Sample Type Comparison:

A study was conducted to examine and compare heparinized venous whole blood and serum on the Piccolo® Point-of-Care Chemistry Analyzer

Serum, heparinized plasma and heparinized whole blood comparability were established for phosphorus. Phosphorous concentrations in serum are 0.3 mg/dL higher than in heparinized plasma and heparinized whole blood.

#### 8. Conclusions

The clinical and non-clinical tests performed for phosphorus, 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.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

5 2002 SEP

Mr. Robert Milder Chief of Operations Officer Abaxis Inc. 3240 Whipple Road Union City, CA 94587

Re: k022312

> Trade/Device Name: Piccolo® Phosphorus Test System Regulation Number: 21 CFR 862.1580 Regulation Name: Phosphorus (inorganic) Test System Regulatory Class: Class I Product Code: CEO Dated: July 15, 2002 Received: July 17, 2002

Dear Mr. Milder:

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.

{5}------------------------------------------------

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 1 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/dsma/dsmamain.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

{6}------------------------------------------------

#### INDICATIONS FOR USE STATEMENT 12.0

### Indications for Use

510(k) Number (if known): K022312

Piccolo® Phosphorus Test System Device Name:

### Intended Use:

The Piccolo Phosphorus Test System (presently contained on the Renal Function Panel Reagent disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of phosphorus in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

### Indications for Use:

Phosphorus The phosphorus assay is used for the quantitiation of phosphorus in human heparinized whole blood, heparinized plasma or serum. Phosphorus measurements are used in the diagnosis and treatment of renal insufficiency, hypoparathyroidism, vitamin D imbalance, a high calcium diet, hyperparathyroidism, and insulin treatment of diabetic ketacidosis.

Jtan Coog

(Division Sign-Off)
Division of Clinical Labora!
510(k) Number K022312

# (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)