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.

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.

Device Description

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 blood cells. The disc meters the required quantity of plasma and diluent, mixes 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Piccolo® Sodium Test System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Summary of Safety and Effectiveness" and the "Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence." Since this is a 510(k) submission, the primary acceptance criterion is substantial equivalence to the predicate device. The performance data presented are used to support this claim.

Performance Metric	Acceptance Criteria (Implied by Predicate Equivalence & Good Performance)	Reported Device Performance (Piccolo® Sodium Test System)
Accuracy (vs. Predicate)	Correlation coefficient, slope, intercept, and standard error (SEE) indicative of strong agreement with the predicate device (Radiometer KNA™ 2 Sodium-Potassium Analyzer). While specific numerical thresholds aren't stated, the values should demonstrate clinical acceptability and comparable performance to the predicate.	- Sample Size (n): 113 - Correlation Coefficient: 0.937 - Slope: 0.782 - Intercept: 27.70 - SEE: 3.79 - R-Square: 0.878 (These values are provided for comparison to the predicate, with no explicit predicate values given for these metrics other than it is the comparator.)
Linearity	Statistically linear at the 99% significance level (F-test with 99% Critical F of 2.99).	- F-Ratio: 0.99 - Slope: 0.99 - Intercept: -1.00 - Corr. Coefficient: 1.00 (Data found to be statistically linear at the 99% significance level by the F-test.)
Precision (Within-Run)	Low standard deviation (SD) and coefficient of variation (CV) at different concentration levels (Moni-Trol 1 and Moni-Trol 2).	Moni-Trol 1 (Mean 144): - SD: 2.3 - CV: 1.6 Moni-Trol 2 (Mean 120): - SD: 2.1 - CV: 1.8
Precision (Total)	Low standard deviation (SD) and coefficient of variation (CV) at different concentration levels (Moni-Trol 1 and Moni-Trol 2).	Moni-Trol 1 (Mean 144): - SD: 2.3 - CV: 1.6 Moni-Trol 2 (Mean 120): - SD: 2.1 - CV: 1.8
Sample Type Comparability	Venous whole blood and serum result in comparable sodium measurements.	Serum and whole blood comparability were established for sodium.

2. Sample Size Used for the Test Set and Data Provenance

Accuracy Test Set Sample Size: 113
Precision Test Set Sample Size: 80 (Results pooled from 4 instruments, each running 20 discs)
Data Provenance: Not explicitly stated, but given the context of a US 510(k) submission, it is assumed to be from a US-based study. It is a prospective study as tests were "performed" using the system to demonstrate equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. The ground truth for this type of in vitro diagnostic device (IVD) study is typically established by measurements from a legally marketed predicate device or a recognized reference method, rather than expert interpretation of images or clinical assessments. The predicate device (Radiometer KNA™ 2 Sodium-Potassium Analyzer, K830805) serves as the comparator.

4. Adjudication Method for the Test Set

Not applicable. This type of study for an IVD does not involve expert adjudication as it is comparing quantitative measurements against a predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is an in vitro diagnostic device (chemistry analyzer) and does not involve human readers or AI assistance in the context of interpretation that would require an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this is a standalone performance study. The Piccolo® Sodium Test System, as an IVD, performs the measurement and provides a quantitative output by itself. The reported performance metrics (accuracy, linearity, precision) are reflective of the device's standalone performance.

7. The Type of Ground Truth Used

The ground truth for the accuracy study was established by comparison to a legally marketed predicate device, the Radiometer KNA™ 2 Sodium-Potassium Analyzer (K830805). Other studies like linearity and precision use reference solutions or controls with known concentrations.

8. The Sample Size for the Training Set

Not applicable. This device is a chemistry analyzer, not an AI/ML algorithm that requires a training set in the conventional sense. Its "training" is in its engineering design, calibration, and manufacturing, not data-driven machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the context of AI/ML. The device's calibration and operational parameters are established through manufacturing processes and quality control, which would involve known reference materials and standards to ensure accurate measurements.

Summary

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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 DriveSunnyvale, CA 94089

Contact Person:	Lisa G. McGrath
Phone Number:	(408) 745-6880
Fax Number:	(408) 734-2874

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. 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-Potassium Analyzer	RadiometerAmerica, 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-CareChemistry Analyzer	Radiometer KNA™ 2 SodiumPotassium Analyzer
Intended Use	quantitative analysis ofsodium	quantitative determination ofsodium
Methodology	enzymatic activation	ion-selective electrodes
Sample Type	whole blood, plasma,serum	whole blood, plasma,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-specific calibration data	automatic 1 point calibrationevery 2 hours; 2 pointcalibration 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:Within-Run and Total Precision of Sodium Runon the Piccolo Point-of-Care Chemistry AnalyzerA
	Within-Run(n = 80)	Total(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 (770) 488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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:

Indications for Use:

	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)

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

Regulation Number and Section

§ 862.1665 Sodium test system.

(a)
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.(b)
Classification. Class II.