PICCOLO SODIUM TEST SYSTEM

K993211 · Abaxis, Inc. · JGS · Oct 25, 1999 · Clinical Chemistry

Device Facts

• Record ID: K993211
• Device Name: PICCOLO SODIUM TEST SYSTEM
• Applicant: Abaxis, Inc.
• Product Code: JGS · Clinical Chemistry
• Decision Date: Oct 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Intended Use

The Piccolo® MetLyte 7 Reagent Disc (contains Piccolo Sodium Test System) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of sodium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

Device Story

Piccolo Sodium Test System uses heparinized whole blood, plasma, or serum samples; processed via Piccolo MetLyte 7 Reagent Disc. Device separates blood cells from plasma; meters plasma and diluent; mixes with dry reagent beads in reaction cuvettes. Chemical reactions monitored by Piccolo Point-of-Care Chemistry Analyzer at 37°C. Analyzer uses bar-coded disc-specific calibration data. Used in clinical labs or point-of-care settings by healthcare professionals. Output is quantitative sodium concentration; aids clinicians in diagnosing/treating fluid/electrolyte disorders like dehydration, hyponatremia, and hyperaldosteronism.

Clinical Evidence

Bench testing only. Linearity established at 99% significance level (F-ratio 0.99). Precision studies (n=80) showed CVs of 1.6-1.8%. Clinical correlation study (n=113) compared subject device to predicate, yielding correlation coefficient of 0.937, slope 0.782, and intercept 27.70.

Technological Characteristics

System consists of Piccolo Point-of-Care Chemistry Analyzer and MetLyte 7 Reagent Disc. Sensing principle: enzymatic activation. Reagents: dry, test-specific beads. Calibration: bar-coded disc-specific data. Operating temperature: 37°C. Assay range: 110-170 mmol/L.

Indications for Use

Indicated for quantitative determination of sodium in human heparinized whole blood, heparinized plasma, or serum. Used in diagnosis and treatment of dehydration, diabetes insipidus, loss of hypotonic gastrointestinal fluids, salt poisoning, thirst sense depression, skin losses, burns, sweating, hyperaldosteronism, CNS disorders, hyponatremia, and syndrome of inappropriate ADH secretion.

Regulatory Classification

Identification

A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Predicate Devices

• KNA™ 2 Sodium-Potassium Analyzer (K830805)

Submission Summary (Full Text)

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Summary of Safety and Effectiveness, Page 4

## Sample Type Comparison:

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

Serum and whole blood comparability were established for sodium.

#### 8. Conclusions

The clinical and non-clinical tests performed using the Piccolo Sodium Test System (contained on the Piccolo MetLyte 7 Reagent Disc) demonstrate that the device is as safe, effective and performs as well as the legally marketed predicate device identified above.

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OCT 25 599

1320 Chesapeake Terrace, Sunnyvale, CA 84089
Phone 408 • 734-0200 Fax 408 • 734-2874

Image /page/1/Picture/2 description: The image shows the word "ABAXIS" in a stylized font. The letters are in black and are bold. A black oval shape surrounds the letters "XIS" in the word. The font is sans-serif and appears to be a logo.

This 510(k) summary of safety and effectiveness information is being submitted in
tell and experience of the COMDA 4000 and 21 CER 807 92 This 510(K) summary of salety and Chocaveness .
accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K993211

### Applicant Information: 1.

| Date Prepared: | September 23, 1999 |
|----------------|----------------------------------------------|
| Name: | Abaxis, Inc. |
| Address: | 1320 Chesapeake Drive<br>Sunnyvale, CA 94089 |

| Contact Person: | Lisa G. McGrath |
|-----------------|-----------------|
| Phone Number: | [phone] |
| Fax Number: | [phone] |

### Device Information: 2.

| Classification | Class II |
|----------------|-----------------------------|
| Trade Name: | Piccolo® Sodium Test System |

Classification Name:

Sodium test system 862.1665

## ldentification of legally marketed device to which the submitter claims 3. equivalence:

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

| : 24 8 2 3 0 ( 2002 16) : 1 ( 1 ( 1 ) ( 1 ) ( 1 ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) | 11:1011117 10:44 r : 5 - | 1131 - 101 - 14 | 1718: 0) - 295<br>. 1728 : } : 38 : 18 : 3 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : 1 : |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| KNA™ 2 Sodium-<br>Potassium Analyzer | Radiometer<br>America, Inc. | K830805 | 4/8/83 |

### Description of the Device: 4.

The Piccolo Sodium Test System (contained on the Piccolo MetLyte 7 Reagent Disc) is designed to separate a heparinized whole blood sample into plasma and Disc) is designed to beparate a neguired quantity of plasma and diluent, mixes the discus blood cells. The diso meters the mixture to the reaction cuvettes along the disc

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# Summary of Safety and Effectiveness, Page 2

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® MetLyte 7 Reagent Disc (contains Piccolo Sodium Test System) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of sodium 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 Sodium Test System in comparison to the legally marketed predicate device.

| | Piccolo Point-of-Care<br>Chemistry Analyzer | Radiometer KNA™ 2 Sodium<br>Potassium Analyzer |
|-------------------|--------------------------------------------------|--------------------------------------------------------------------------------------|
| Intended Use | quantitative analysis of<br>sodium | quantitative determination of<br>sodium |
| Methodology | enzymatic activation | ion-selective electrodes |
| Sample Type | whole blood, plasma,<br>serum | whole blood, plasma,<br>serum, urine |
| Sensitivity | 2.8 (A mA/min)/(mmol/L) | 3.1 (mmol/L)/(mV) |
| Reagents | dry, test specific reagent beads | N/A |
| Temperature | 37°C | 37° C |
| Calibration | bar code with disc-<br>specific calibration data | automatic 1 point calibration<br>every 2 hours; 2 point<br>calibration every 8 hours |
| Assay Range | 110 - 170 mmol/L | 7 - 350 mmol/L |
| Accuracy: | | |
| Sample size (n) | 113 | |
| Corr. Coefficient | 0.937 | |
| Slope | 0.782 | |
| Intercept | 27.70 | |
| SEE | 3.79 | |
| R-Square | 0.878 | |

Table 1 : Specification Comparison: Piccolo Sodium Test System

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# Summary of Safety and Effectiveness, Page 3

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

Table 2 summarizes the results of clinical and non-clinical tests performed using the Piccolo® Sodium Test System.

# Linearity:

Data for sodium were found to be statistically linear at the 99% significance level by the Ftest.

| Table 2 | |
|----------------------|--------|
| Summary of Linearity | |
| | Sodium |
| F-Ratio | 0.99 |
| Slope | 0.99 |
| Intercept | -1.00 |
| Corr. Coefficient | 1.00 |

99% Critical F 2.99

# Precision:

Precision studies were designed to evaluate within-run and total precision of sodium included on the Piccolo MetLyte 7 Reagent Disc when run on the Piccolo Point-of-Care Chemistry Analyzer.

| Table 3:<br>Within-Run and Total Precision of Sodium Run<br>on the Piccolo Point-of-Care Chemistry AnalyzerA | | |
|--------------------------------------------------------------------------------------------------------------|------------------------|------------------|
| | Within-Run<br>(n = 80) | Total<br>(n= 80) |
| Moni-Trol 1 | | |
| Mean | 144 | 144 |
| SD | 2.3 | 2.3 |
| CV | 1.6 | 1.6 |
| Moni-Trol 2 | | |
| Mean | 120 | 120 |
| SD | 2.1 | 2.1 |
| CV | 1.8 | 1.8 |

A Results pooled from 4 instruments each running 20 discs.

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Image /page/4/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 image of an eagle or bird with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services.

OCT 2 5 1999

Ms. Lisa G. McGrath Regulatory Affairs Specialist Abaxis 1320 Chesapeake Terrace Sunnyvale, California 94089

Re: K993211

> Trade Name: Piccolo® Sodium Test System Regulatory Class: II Product Code: JGS Dated: September 23, 1999 Received: September 24, 1999

Dear Ms. McGrath:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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## Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman

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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| | Indications for Use | |
|---------------------------|---------------------|--|
| 510(k) Number (if known): | K993211 | |

Piccolo® Sodium Test System Device Name:

Intended Use:

The Piccolo Sodium Test System (contained on the MetLyte 7 Reagent Disc), used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of sodium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

## Indications for Use:

The sodium assay is used for the quantitation of sodium in human heparinized whole blood, heparinized plasma, or serum. Sodium measurements are used in the diagnosis and treatment of dehydration, diabetes insipidus, loss of hypotonic gastrointestinal fluids, sait poisoning, selective depression of sense of thirst, skin losses, burns, sweating, hyperaldosteronism, CNS disorders, dilutional, depletional and delusional hyponatremia and syndrome of inappropriate ADH secretion.

| | and delusional hyponatr |
|---------------------|---------------------------------|
| | ean Cooper |
| (Division Sign-Off) | |
| | Division of Clinical Laboratory |
| | vice: |
| 510(k) Number | K993211 |

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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ﺴﻠ Prescription Use (Per 21 CFR 801.109)

OR

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

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