K Number

Device Name

PICCOLO TRIGLYCERIDES TEST SYSTEM

Manufacturer

ABAXIS, INC.

Date Cleared

2003-01-24

(86 days)

Product Code

JGY

Regulation Number

862.1705

Intended Use

The Piccolo Triglycerides Test System used with the Piccolo Point-of-Care Chemistry Analyzer is intended for the in vitro quantitative determination of triglycerides in heparinized whole blood, heparinized plasma, or serum 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 Reagent Disc (which contains the Piccolo® Triglycerides 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 analvzer. Alternately, the disc mav also be used with serum.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K854152

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard in vitro diagnostic (IVD) chemistry analyzer and reagent disc. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on standard analytical metrics like linearity, precision, and method comparison.

Therapeutic

No.
The device is used for in vitro quantitative determination of triglycerides to aid in diagnosis and treatment, but it does not directly treat or prevent a disease.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that "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," indicating its role in diagnosis.

SaMD (Software as a Medical Device)

The device description clearly details a physical reagent disc and its interaction with a chemistry analyzer, indicating it is a hardware-based system, not software-only.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is intended for the "in vitro quantitative determination of triglycerides". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
Sample Type: The device uses biological samples (heparinized whole blood, heparinized plasma, or serum) which are tested outside of the body.
Purpose: The measurements are used in the "diagnosis and treatment of patients," which is a primary function of IVDs.
Clinical Setting: The intended use specifies a "clinical laboratory setting or point-of-care location," which are typical environments for IVD use.
Device Description: The description details how the device processes the biological sample and performs chemical reactions to obtain a result, consistent with how IVDs function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

JGY

Device Description

The Piccolo® Lipid Panel Reagent Disc (which contains the Piccolo® Triglycerides 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 The diluted plasma mixes with the reagent beads, initiating the disc perimeter. chemical reactions that are then monitored by the analvzer. Alternately, the disc mav also be used with serum.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinical laboratory setting or point-of-care location

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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 Piccolo® Point-of-Care Chemistry Analyzer.
Table 3: Within-Run and Total Precision of Triglycerides Assayed on the Piccolo® Point-of-Care Chemistry Analyzer
Within-Run (n =160), Total (n =160)
Triglycerides (mg/dL)
Serum 1
Mean: 206.8 (Within-Run), 206.8 (Total)
SD: 4.7 (Within-Run), 5.5 (Total)
%CV: 2.3 (Within-Run), 2.6 (Total)
Serum 2
Mean: 163.7 (Within-Run), 163.7 (Total)
SD: 1.8 (Within-Run), 2.4 (Total)
%CV: 1.1 (Within-Run), 1.5 (Total)

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 triglycerides.

Method Comparison:
Table 4: Method Comparison Data for Triglycerides Assayed on the Using the Abaxis Piccolo® TRIG Assay and the Bayer TRIG Assay
Parameters:
Piccolo TRIG Test System, n*: 172
Bayer Triglycerides Assay, n*: 172
Piccolo TRIG Test System, Mean: 162
Bayer Triglycerides Assay, Mean: 156
Piccolo TRIG Test System, Std. Dev.: 87.6
Bayer Triglycerides Assay, Std. Dev.: 89.0
Piccolo TRIG Test System, Range of Samples: 46 - 488
Bayer Triglycerides Assay, Range of Samples: 38 - 487

Linear Regression:
n*: 172
Slope: 0.983
Intercept: 8.2
Correlation Coefficient (r): 0.999
Std. Error of the Estimate (SEE): 4.4

Deming Regression:
n*: 172
Slope: 0.984
Intercept: 8.1
Correlation Coefficient (r): 0.999
Std. Error of the Estimate (SEE): N/A
· n = all data points (patient samples were run in duplicate and both values were plotted; number of patient samples = n/2)

Key Metrics

Sensitivity: 3.82 mA per mg/dL or 0.338 A per mmol/L; 20 mg/dL
Correlation Coefficient (r): 1.000 (Linearity), 0.999 (Method Comparison)

Predicate Device(s)

K854152

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

JAN 2 4 2003

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: _______________________________________________________________________________________________________________________________________________

1. Applicant Information:

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

2. Device Information:

Classification Class I Piccolo® Triglycerides Test System Trade Name:

Classification Name: Triglycerides Test system 862.1705

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

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

Predicate Device	Manufacturer	510(k) Number
Triglycerides-RA
Assay Run on a
Hitachi 917 Clinical
Chemistry Analyzer	Bayer Diagnostics	K854152*
(Technicon RA
Systems for
Triglycerides
Analysis)	11/5/85

*Presumptive K number. NOTE: The predicate device is currently known as Bayer Diagnostics Triglyceride Reagent. Since Bayer has undergone a series of mergers and

other business transactions (e.g., Bayer, Technicon, Miles, Ames), the exact regulatory "lineage" is difficult to determine.

Description of the Device: 4.

The Piccolo® Lipid Panel Reagent Disc (which contains the Piccolo® Triglycerides 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 The diluted plasma mixes with the reagent beads, initiating the disc perimeter. chemical reactions that are then monitored by the analvzer. Alternately, the disc mav also be used with serum.

5. Statement of Intended Use:

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

Specification Comparison for Piccolo Triglycerides (TRIG) Test Table 1: System versus Bayer Triglycerides-RA Assay

| | Piccolo Triglycerides Assay on
Abaxis Point-of-Care
Chemistry Analyzer | Bayer Triglycerides-RA Assay
on Hitachi 917 Analyzer |
|-------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Intended Use | Quantitative analysis of
triglycerides | Quantitative analysis of
triglycerides |
| Methodology | Enzymatic endpoint reaction | Enzymatic endpoint reaction |
| Sample Type | Heparinized whole blood,
heparinized plasma, and
serum | Heparinized plasma and serum |
| Sensitivity | 3.82 mA per mg/dL or 0.338 A
per mmol/L; 20 mg/dL | 0.99 mA per mg/dL or 0.088 A per
mmol/L |
| Reagents | Dry test-specific reagent beads
and liquid diluent; reconstitution
performed by analyzer | Dry reagents (reconstituted by user
prior to use) and liquid reagents |
| Temperature of Reaction | 37°C | 37°C |
| Calibration | Bar code with factory
calibrated lot specific data | Calibrated periodically using
calibrators supplied by vendor |
| Assay Range | 20 - 500 mg/dL | 0 - 500 mg/dL |
| Testing Environment | Professional use | Professional use |
| Sample Size | Approx 100 µL | 2 pl |

Brief Discussion of the Clinical and Nonclinical Tests Relied on for a 7. 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 Piccolo® Point-of-Care Chemistry Analyzer.

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

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 triglycerides.

Method Comparison:

Table 4: Method Comparison Data for Triglycerides Assayed on the Using the
Abaxis Piccolo® TRIG Assay and the Bayer TRIG Assay

	Parameters	Statistics
Piccolo TRIG Test System	n*	172
Bayer Triglycerides Assay	n*	172
Piccolo TRIG Test System	Mean	162
Bayer Triglycerides Assay	Mean	156
Piccolo TRIG Test System	Std. Dev.	87.6
Bayer Triglycerides Assay	Std. Dev.	89.0
Piccolo TRIG Test System	Range of Samples	46 - 488
Bayer Triglycerides Assay	Range of Samples	38 - 487

	Linear Regression	Deming Regression
n*	172	172
Slope	0.983	0.984
Intercept	8.2	8.1
Correlation Coefficient (r)	0.999	0.999
Std. Error of the Estimate (SEE)	4.4	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® Triglycerides 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.

Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines that suggest the head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug 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: K023639

Trade/Device Name: Piccolo Triglycerides Test System Regulation Number: 21 CFR 862.1705 Regulation Name: Triglyceride test system Regulatory Class: Class I Product Code: JGY 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).

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

INDICATIONS FOR USE STATEMENT 12.0

Indications for Use

K0236334 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Piccolo® Triglycerides Test System Device Name:

Intended Use:

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------

Prescription Use	✓	OR	Over- The Counter Use
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number	K023639
---------------	---------