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.

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.

Device Description

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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the Abaxis Piccolo® Phosphorus Test System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" but rather presents performance characteristics derived from linearity and precision studies. The implicit acceptance is that these results demonstrate the device performs "as well as the legally marketed device."

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Linearity	(Comparable to predicate & industry standards for a quantitative assay)
Slope	(Close to 1.00)	1.00
Intercept	(Close to 0.00)	+0.2
Corr. Coefficient	(Close to 1.00)	0.999
Sample Range	(Clinically relevant)	2 - 17 mg/dL
Precision	(Clinically acceptable CV)
Level 1 (3.1 mg/dL)
Within-Run CV	(Within acceptable limits)	3.7% (n=80)
Total CV	(Within acceptable limits)	4.7% (n=80)
Level 2 (7.3 mg/dL)
Within-Run CV	(Within acceptable limits)	1.3% (n=80)
Total CV	(Within acceptable limits)	2.0% (n=80)
Sample Type Comparison	(Comparability between sample types)	Phosphorous concentrations in serum are 0.3 mg/dL higher than in heparinized plasma and heparinized whole blood. (Comparability was established)

2. Sample Size for the Test Set and Data Provenance

Linearity Study: Sample range 2 - 17 mg/dL. The exact number of individual samples (data points) used to determine linearity properties (slope, intercept, correlation coefficient) is not explicitly stated, beyond the range.
Precision Study: n = 80 for both within-run and total precision at each of the two levels tested. This n likely refers to the number of replicates over time or runs to calculate precision.
Sample Type Comparison: The document does not specify the number of samples used for this comparison.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission for a clinical laboratory device, these studies are typically conducted under controlled laboratory conditions, which would be considered prospective for the purpose of device validation.

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

No experts were used to establish ground truth in this type of study. These are analytical performance studies for an in vitro diagnostic device measuring a chemical analyte. The "ground truth" for linearity and precision is established by the reference methods or highly accurate control materials used to create the samples and by the inherent statistical calculations for precision.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is an analytical performance study, not one requiring expert adjudication of clinical findings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is typically associated with image-based diagnostic aids or clinical decision support systems where human interpretation is involved. This device is an automated chemistry analyzer, so human reader improvement is not a relevant metric.

6. Standalone Performance Study

Yes, the studies described (linearity, precision, sample type comparison) represent the standalone performance of the algorithm/device (Piccolo® Phosphorus Test System). These tests evaluate the inherent analytical capabilities of the system without human intervention in the result generation process itself, beyond operating the instrument.

7. Type of Ground Truth Used

Linearity: The ground truth is established by the known concentrations of the samples used in the linearity study (e.g., diluted reference materials or spiked samples).
Precision: The ground truth is the mean concentration of the control materials or samples tested, against which the variability (SD, CV) is measured.
Sample Type Comparison: The ground truth is the measured values from the different sample types (serum, plasma, whole blood) compared against each other, presumably with one acting as a reference or a comparison of their inherent differences.

8. Sample Size for the Training Set

The document does not mention a "training set" or "training data." This is because the Piccolo® Phosphorus Test System is a quantitative chemical analyzer based on established enzymatic endpoint reaction methodology. Its performance is characterized analytically, rather than through machine learning models that require training data. The device likely uses factory-calibrated lot-specific data for calibration, as mentioned in Table 1, but this is not a "training set" in the machine learning sense.

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

Not applicable, as no training set (in the machine learning context) was described or used.

Summary

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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 RoadUnion City, CA 94587
Contact Person:	Robert Milder

Contact Person:	Robert Milder
Phone Number:	(510) 675-6524
Fax Number:	(510) 441-6150

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)Number	Date of SEDetermination
Phosphorus Slides onthe Vitros 950Chemistry System	Johnson andJohnson ClinicalDiagnostics	K932729	8/3/93

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Summary of Safety and Effectiveness,

4. Description of the Device:

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 ChemistryAnalyzer	Vitros 950 ChemistrySystem
Intended Use	Quantitative analysis of phosphorus	Quantitative analysis of phosphorus
Methodology	Enzymatic endpoint reaction	Colorimetric
Sample Type	Heparinized whole blood,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 andammonium molybdate
Temperature	37°C	37°C
Calibration	Bar code with factorycalibrated lot specific data	Calibrated periodically usingcalibrators 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

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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(n = 80)	Total(n = 80)
Phosphorus (mg/dL)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

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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.

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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.

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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 (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" (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 (800) 638-2041 or (301) 443-6597 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

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INDICATIONS FOR USE STATEMENT 12.0

Indications for Use

510(k) Number (if known): K022312

Piccolo® Phosphorus Test System Device Name:

Intended Use:

Indications for Use:

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)

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

Regulation Number and Section

§ 862.1580 Phosphorus (inorganic) test system.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.