The Piccolo Triglycerides - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of triglycerides in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location.

Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders.

Device Description

The Piccolo® Lipid Panel - Capillary Reagent Disc (which contains the Piccolo® Triglycerides - Capillary 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Piccolo® Triglycerides - Capillary Test System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct thresholds in this summary. Instead, the summary presents the performance characteristics and implies that these results demonstrate substantial equivalence to predicate devices. For this table, I'll present the performance characteristics provided.

Performance Metric	Acceptance Criteria (Implied / Comparator)	Reported Device Performance (Piccolo® Triglycerides - Capillary Test System)
Linearity	Slope = 1, Intercept = 0, R = 1	Slope: 1.000, Intercept: 3.0, Correlation Coefficient (r): 1.000
Precision (Within-Run)	Low %CV for various concentration levels	Serum 1: Mean 206.8 mg/dL, SD 4.7, %CV 2.3Serum 2: Mean 163.7 mg/dL, SD 1.8, %CV 1.1
Precision (Total)	Low %CV for various concentration levels	Serum 1: Mean 206.8 mg/dL, SD 5.5, %CV 2.6Serum 2: Mean 163.7 mg/dL, SD 2.4, %CV 1.5
Method Comparison (vs. Roche Triglycerides Test)	Close agreement with predicate; Slope ~ 1, Intercept ~ 0, R² ~ 1	N: 588Mean: 155.4 mg/dLStd. Dev: 88.3Range: 36 - 496 mg/dLSlope (95% CI): 0.96 (0.95 to 0.97)Intercept (95% CI): 3.5 (2.1 to 4.9)Correlation Coefficient (R²): 0.992Std. Error of the Estimate (SEE): 7.9

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

Sample Size for Linearity: Not explicitly stated, but the "Summary of Linearity" implies sufficient samples were used to generate the reported slope, intercept, and correlation coefficient.
Sample Size for Precision: 160 observations (n=160) for both within-run and total precision for each serum level.
Sample Size for Method Comparison: 588 samples (N=588).
Data Provenance: Not explicitly stated (e.g., country of origin). The data is from "clinical and non-clinical tests performed using the Piccolo® Triglycerides Test System," implying it was generated specifically for this submission. It's prospective testing as the device underwent testing.

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

This information is not applicable to an in vitro diagnostic (IVD) device that measures a biomarker. The "ground truth" for these tests is typically established through reference methods or highly accurate laboratory analyzers, not expert interpretation. In this case, the Roche Triglycerides Test on the Cobas 6000 Analyzer serves as the comparator or reference method for the method comparison study.

4. Adjudication Method for the Test Set

Not applicable for this type of IVD device. Test results are quantitative measurements, not subjective interpretations requiring adjudication.

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

Not applicable. This is an in vitro diagnostic device for quantitative blood analysis, not an AI-assisted diagnostic imaging or interpretation system involving human readers.

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

Yes, the performance data presented (linearity, precision, method comparison) represents the standalone performance of the Piccolo® Triglycerides - Capillary Test System. It measures triglyceride levels quantitatively without direct human interpretation of the primary result (beyond initiating the test and reading the numerical output).

7. The Type of Ground Truth Used

For the method comparison study, the "ground truth" (or reference method) was the Roche Triglycerides Test performed on the Cobas 6000 Analyzer, with results reported as the "Average of Duplicates."

8. The Sample Size for the Training Set

Not applicable. This device is a diagnostic test kit and analyzer, not a machine learning or AI algorithm that requires a "training set." Its calibration is based on "Bar code with factory calibrated lot specific data" (Table 1), implying chemical calibration and quality control rather than data-driven machine learning training.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The calibration of the device is factory-set and lot-specific using bar codes, as noted in Table 1.

Summary

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Piccolo® Triglycerides - Capillary Test System

510(k) Premarket Notification

K120664
APR 24 2012

APPENDIX D

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

3240 Whipple Road, Union City, CA 94587 Phone 510 . 675-6500 Fax 510 . 441-6150

Image /page/0/Picture/20 description: The image shows the word "ABAXIS" in a bold, sans-serif font. A stylized oval shape encircles the "X" in the word, adding a dynamic element to the design. The overall impression is clean and modern, suggesting a professional and innovative company.

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:

1. Applicant Information:

Date Prepared:Name:Address:	March 2, 2012Abaxis, Inc.3240 Whipple RoadUnion City, CA 94587
Contact Person:Dhana Mundau	Dennis M. Bleile, PhDICHOS COLE

Contact Person:	Dennis M. Bielle, PhD
Phone Number:	(510) 675-6515
Fax Number:	(510) 441-6150

2. Device Information:

Classification	Class I
Trade Name:	Piccolo® Triglycerides - Capillary Test System

Classification Name: Triglycerides Test system 862.1705

3. Identification of Legally Marketed Devices to which the Submitter Claims Equivalence:

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

Predicate Devices
Predicate Device	Manufacturer	510(k)Number	Date of SEDetermination
Piccolo® TriglyceridesTest System	AbaxisUnion City, CA	K023639	1/24/2003
Cobas® TriglyceridesTest	Roche DiagnosticsIndianapolis, IN	K893973	08/11/1989

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Summary of Safety and Effectiveness (continued)

4. Description of the Device:

Statement of Intended Use: 5.

Summary of the Technological Characteristics of the New Device in 6. Comparison to those of the Predicate Device:

Table 1 outlines the technological characteristics of the Piccolo® Triglycerides -Capillary Test System in comparison to the legally marketed predicate device.

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ಿ Triglycerides - Capillary Test System Picc

Summary of Safety and Effectiveness (continued)

Table 1: Specification Comparison for Piccolo Triglycerides – Capillary Test System, Piccolo Triglycerides Test System
and the Roche Triglycerides Test on the Cobas 6000 Ana

	Piccolo Triglycerides –Capillary Test on AbaxisChemistry Analyzer	Piccolo Triglycerides Test onAbaxis Chemistry Analyzer	Roche Triglycerides Test onthe Cobas 6000 Analyzer
Intended Use	Quantitative analysis ofTriglycerides	Quantitative analysis ofTriglycerides	Quantitative analysis ofTriglycerides
Methodology	Enzymatic endpoint reaction	Enzymatic endpoint reaction	Enzymatic endpoint reaction
Sample Type	Lithium heparinized capillary wholeblood	Lithium heparinized whole blood,heparinized plasma, andserum	Lithium heparin and potassiumEDTA plasma and serum
Dynamic RangeLower Limit	20 mg/dL	20 mg/dL	3.86 mg/dL
Reagents	Dry test-specific reagent beadsand liquid diluent; reconstitutionperformed by analyzer	Dry test-specific reagent beadsand liquid diluent; reconstitutionperformed by analyzer	Liquid reagent
Temperature ofReaction	37°C	37°C	37°C
Calibration	Bar code with factorycalibrated lot specific data	Bar code with factorycalibrated lot specific data	Calibrated periodically usingcalibrators supplied by vendor
Assay Range	20-500 mg/dL	20-500 mg/dL	8.85-885 mg/dL
Testing Environment	Professional use	Professional use	Professional use
Sample Size	Approx 100 µL	Approx 100 μL	2 µL

baxis Confidentia

・ . .

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Summary of Safety and Effectiveness (continued)

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® Triglycerides Test System.

Linearity:

Table 2: Summary of Linearity

	Triglycerides
Slope	1.000
Intercept	3.0
Correlation Coefficient (r)	1.000

Precision:

Precision studies were designed to evaluate within-run and total precision of
triglycerides included on the Piccolo® Lipid Panel Reagent Disc when run on the Abaxis analyzer.

Table 3: Within-Run and Total Precision of Triglycerides Assayed on the Abaxis Analyzer

	Within-Run(n =160)	Total(n =160)
Triglycerides (mg/dL)
Serum 1
Mean	206.8	206.8
SD	4.7	5.5
%CV	2.3	2.6
Serum 2
Mean	163.7	163.7
SD	1.8	2.4
%CV	1.1	1.5

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Summary of Safety and Effectiveness (continued)

Method Comparison:

Table 4: Method Comparison Data for Triglycerides Assayed by the Abaxis Piccolo Triglycerides - Capillary Test System and the Roche Triglycerides Test

Parameters	Statistics
Piccolo Triglycerides - Capillary: Singlicate Values, N	588
Roche Triglycerides Assay: Average of Duplicates, N	588
Piccolo Triglycerides - Capillary: Mean	155.4
Roche Triglycerides Assay: Mean	157.5
Piccolo Triglycerides - Capillary: Std. Dev.	88.3
Roche Triglycerides Assay: Std. Dev	91.6
Piccolo Triglycerides - Capillary: Range of Samples	36 - 496
Roche Triglycerides Assay: Range of Samples	33.5 - 528

Parameters (Roche on X Axis)	Linear Regression	Deming Regression
N	588	588
Slope (95% CI)	0.96 (0.95 to 0.97)	0.96 (0.95 to 0.97)
Intercept (95% CI)	4.1 (2.8 - 5.4)	3.5 (2.1 to 4.9)
Correlation Coefficient (R²)	0.992	0.992
Std. Error of the Estimate (SEE)	7.9	7.9

8. Conclusions

The clinical and non-clinical tests performed using the Piccolo® Triglycerides =
Capillary Test System, when run on the Piccolo xpress Chemistry Analyzer, Supillary - Foot - System is as safe, effective and performs as well as the legally marketed devices identified above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a human figure, represented by flowing lines, suggesting a sense of movement and connection.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Abaxis, Inc. c/o Dennis M. Bleile, Ph.D., RAC Director of Assay Performance and Compliance 3240 Whipple Road Union City, CA 94587

APR 2 4 2012

Re: K120664

Trade/Device Name: Piccolo Triglycerides - Capillary Test System Regulation Number: 21 CFR 862.1705 Regulation Name: Triglyceride Test System Regulatory Class: Class I, meets limitations of exemptions per 21 CFR 862.9 (c)(4) Product Code: JGY Dated: March 2, 2012 Received: March 5, 2012

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).

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.

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

$\mathcal{N}$

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Piccolo® Triglycerides - Capillary Test System

INDICATIONS FOR USE STATEMENT 12.0

Indications for Use

510(k) Number (if known):

Piccolo® Triglycerides Test System Device Name:

Intended Use:

Indications for Use:

Prescription Use × (Part 21 CFR 801.109 Subpart D) AND/OR

Over- The Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K12066

Page 1 of 1

Regulation Number and Section

§ 862.1705 Triglyceride test system.

(a)
Identification. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.(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.