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

Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Device Description

The Piccolo® Lipid Panel Reagent Disc (which contains the Piccolo® HDL 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 breakdown of the acceptance criteria and the study details for the Abaxis Piccolo® HDL Test System, based on the provided document:

Acceptance Criteria and Device Performance

The document implicitly defines acceptance criteria through the "Specification Comparison" (Table 1) and the various performance studies (Linearity, Precision, Sample Type Comparison, Method Comparison). The primary goal is demonstrating substantial equivalence to the predicate device.

Table of Acceptance Criteria (Implied) and Reported Device Performance:

Acceptance Criteria (Implied from Predicate/Performance Goals)	Reported Device Performance (Piccolo HDL Test System)
Intended Use Equivalence: Quantitative analysis of HDL	Quantitative analysis of HDL
Methodology: Enzymatic colorimetric end-point test	Hybrid enzymatic colorimetric end-point test, making use of dextran/sulfate precipitation, centrifugation, and PEG-modified enzymes
Sample Type: Heparinized plasma and serum	Heparinized whole blood, heparinized plasma, and serum (expanded)
Sensitivity: 3 mg/dL (Predicate)	15 mg/dL (Note: The Piccolo is less sensitive than the predicate, but this is within acceptable clinical limits for HDL measurement)
Reagents: Liquid reagents (Predicate)	Dry test-specific reagent beads and liquid diluent; reconstitution performed by analyzer
Temperature of Reaction: 37°C	37°C
Calibration: Calibrated periodically using calibrators supplied by vendor (Predicate)	Bar code with factory calibrated lot specific data
Assay Range: 3 - 120 mg/dL (Predicate)	15 - 100 mg/dL (Slightly narrower range, but clinically relevant for HDL)
Testing Environment: Professional use	Professional use
Sample Size: 3 µL (Predicate)	Approx 100 µL
Linearity (Correlation Coefficient r): High correlation (e.g., >0.95 expected)	0.997
Precision (Within-Run %CV): Low variability (e.g., <5-10%)	Serum 1: 2.6%; Serum 2: 3.5%
Precision (Total %CV): Low variability (e.g., <5-10%)	Serum 1: 3.5%; Serum 2: 4.3%
Method Comparison (Correlation Coefficient r vs. Predicate): High correlation (e.g., >0.95 expected)	0.965
Method Comparison (Slope vs. Predicate): Close to 1.0 (e.g., 0.9-1.1)	0.851 (Linear), 0.877 (Deming)
Method Comparison (Intercept vs. Predicate): Close to 0 (e.g., -5 to +5)	8.3 (Linear), 6.9 (Deming)

Study that Proves Device Meets Acceptance Criteria:

The document describes several studies conducted to demonstrate the substantial equivalence of the Piccolo® HDL Test System to the predicate device (Roche Diagnostics HDL-C plus Assay on Hitachi 917 Analyzer). The overall conclusion is that "the clinical and non-clinical tests performed using the Piccolo® HDL Test System... demonstrate that the test system is as safe, effective and performs as well as the legally marketed device identified above."

Detailed Study Information:

Sample sizes used for the test set and the data provenance:
- Linearity: Not explicitly stated for specific samples, but the "Summary of Linearity" (Table 2) indicates overall linearity performance.
- Precision: 160 measurements for both within-run and total precision across two serum samples (presumably 80 replicates for each serum sample from the way it's presented).
- Sample Type Comparison: 20 different patient samples were used. Each sample type (serum, heparinized plasma, heparinized whole blood) was tested in quadruplicate.
- Method Comparison: 166 data points (n*) were used. This is clarified as 166 total values, with patient samples run in duplicate, meaning 83 unique patient samples (n/2).
- Data Provenance: Not explicitly stated, but based on the applicant's address and contact, it is likely the studies were conducted in the USA by Abaxis, Inc. The document does not specify if the data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This document describes performance characteristics of a diagnostic device, primarily focused on analytical accuracy and precision compared to a predicate device. The "ground truth" for the test set values (HDL concentrations) would typically be established by the predicate device (Roche HDL Assay) or highly traceable reference methods, rather than human experts assessing the results qualitatively. Therefore, the concept of "number of experts" with specific clinical qualifications is not directly applicable in the context of establishing ground truth for quantitative laboratory tests in this document.
Adjudication method for the test set:
- Not applicable. As this is a quantitative analytical device comparison, adjudication by multiple human experts for a qualitative outcome is not the methodology used. The "ground truth" is typically the quantitative result from the predicate device or a reference method.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for imaging or diagnostic interpretation devices where human readers provide diagnoses or assessments, often with AI assistance. The Piccolo® HDL Test System is a point-of-care chemistry analyzer for quantitative determination of HDL, not an AI-assisted diagnostic interpretation system for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the studies presented (Linearity, Precision, Sample Type Comparison, Method Comparison) are all standalone performance studies of the Piccolo® HDL Test System, evaluating its analytical performance directly. The "human-in-the-loop" aspect for a device like this would involve a clinician ordering the test and interpreting the quantitative result, but the device's performance itself is measured without human interpretive intervention during the assay.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the method comparison study, the Roche HDL Assay on the Hitachi 917 Analyzer served as the reference standard or "ground truth" (i.e., the legally marketed predicate device). For linearity and precision studies, the "ground truth" refers to the expected, known values of control materials or the inherent statistical properties of the measurements themselves.
The sample size for the training set:
- This document describes performance verification studies for a medical device that performs a chemical assay, not an AI/machine learning algorithm that requires a "training set." Therefore, the concept of a "training set" in the context of machine learning is not applicable here. The device uses established chemical reactions and optical detection, not a learned model.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the machine learning sense for this device.

Summary

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JAN 2 4 2003

3240 Whipple Road, Union City, CA 94587 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: K023640

1. Applicant Information:

Date Prepared:	October 29, 2002
Name:	Abaxis, Inc.
Address:	3240 Whipple RoadUnion City, CA 94587
Contact Person:	Dennis M. Bleile, PhD
Phone Number:	(510) 675-6515
Fax Number:	(510) 441-6150

Device Information: 2.

Classification	Class I
Trade Name:	Piccolo® HDL Test System

Classification Name: HDL Test system 862.1475

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	Manufacturer	510(k) Number	Date of SE Determination
HDL-C plus(HDL assay) Runon a Hitachi 917Clinical ChemistryAnalyzer	Roche Diagnostics	K902935*(Roche CobasReady HDLReagent)	9/27/90

Presumptive K number. NOTE: The predicate device is currently known as HDL-C plus, for use on Hitachi instrumentation. Since Roche and Hitachi have a co-marketing agreement, it is assumed that this submission (for the Cobas) is the predicate.

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Description of the Device: 4.

ട. Statement of Intended Use:

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

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Specification Comparison for Piccolo HDL (HDL) Test Table 1: System versus Roche HDL-RA Assay

	Piccolo HDL Assay on AbaxisPoint-of-Care ChemistryAnalyzer	Roche Diagnostics HDL-C plusAssay on Hitachi 917 Analyzer
Intended Use	Quantitative analysis ofHDL	Quantitative analysis ofHDL
Methodology	Hybrid enzymatic colorimetric end-point test, making use ofdextran/sulfate precipitation,centrifugation, and PEG-modifiedenzymes	Homogeneous enzymaticcolorimetric end-point test, makinguse of dextran/sulfate suspensionand PEG-modified enzymes
Sample Type	Heparinized whole blood,heparinized plasma, andserum	Heparinized plasma and serum
Sensitivity	0.00799 A per mg/dL or 0.309 Aper mmol/L; 15 mg/dL	3 mg/dL
Reagents	Dry test-specific reagent beadsand liquid diluent; reconstitutionperformed by analyzer	Liquid reagents
Temperature of Reaction	37°C	37°C
Calibration	Bar code with factorycalibrated lot specific data	Calibrated periodically usingcalibrators supplied by vendor
Assay Range	15 - 100 mg/dL	3 - 120 mg/dL
Testing Environment	Professional use	Professional use
Sample Size	Approx 100 µL	3 µL

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

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

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Linearity:

Table 2: Summary of Linearity

		HDL
Slope		0.983
Intercept		0.5
Correlation Coefficient (r)		0.997

Precision:

Precision studies were designed to evaluate within-run and total precision of HDL included on the Piccolo® Lipid Panel Reagent Disc when run on the Piccolo® Pointof-Care Chemistry Analyzer.

Table 3: Within-Run and Total Precision of HDL Assayed on the Piccolo® Point-of-Care Chemistry Analyzer

	Within-Run(n =160)	Total(n =160)
HDL (mg/dL)
Serum 1
Mean	55.3	55.3
SD	1.4	1.9
%CV	2.6	3.5
Serum 2
Mean	38.0	38.0
SD	1.3	1.6
%CV	3.5	4.3

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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 HDL.

Method Comparison:

Table 4: Method Comparison Data for HDL Assayed on the Using the Abaxis Piccolo® HDL Assay and the Roche HDL Assay

	Parameters	Statistics
Piccolo CHOL Test System	n*	166
Roche HDL Assay	n*	166
Piccolo HDL Test System	Mean	53.2
Roche HDL Assay	Mean	52.8
Piccolo HDL Test System	Std. Dev.	15.1
Roche HDL Assay	Std. Dev.	17.1
Piccolo HDL Test System	Range of Samples	25 - 90
Roche HDL Assay	Range of Samples	23 - 97

	Linear Regression	Deming Regression
n*	166	166
Slope	0.851	0.877
Intercept	8.3	6.9
Correlation Coefficient (r)	0.965	0.965
Std. Error of the Estimate (SEE)	3.9	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® HDL 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 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 symbol that resembles a caduceus, with three figures in profile facing right, representing health and human services.

Food and Druq 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: K023640 Trade/Device Name: Piccolo HDL Test System Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: LBS 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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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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12.0 INDICATIONS FOR USE STATEMENT

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Piccolo® HDL Test System Device Name:

Intended Use:

Indications for Use:

Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)
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Over- The Counter Use (Optional Format 1-2-96)
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(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	A023640

Regulation Number and Section

§ 862.1475 Lipoprotein test system.

(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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 § 862.9.