PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM

K120664 · Abaxis, Inc. · JGY · Apr 24, 2012 · Clinical Chemistry

Device Facts

• Record ID: K120664
• Device Name: PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM
• Applicant: Abaxis, Inc.
• Product Code: JGY · Clinical Chemistry
• Decision Date: Apr 24, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1705
• Device Class: Class 1

Indications for Use

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 Story

System uses Piccolo Lipid Panel Reagent Disc with Piccolo xpress Chemistry Analyzer; processes heparinized capillary whole blood samples. Disc separates plasma from blood cells; meters plasma and diluent; mixes with reagent beads. Analyzer monitors enzymatic endpoint chemical reactions at 37°C. Used in clinical labs or point-of-care settings by professional operators. Output is quantitative triglyceride concentration (mg/dL). Results assist clinicians in diagnosing and managing lipid metabolism, endocrine, and metabolic diseases.

Clinical Evidence

Method comparison study performed at three point-of-care sites using 588 capillary fingerstick samples. Results compared to Roche Cobas Triglycerides Test (k893973) via Deming regression. Combined data showed slope of 0.96 (95% CI: 0.96-0.97), intercept of 3.5 (95% CI: 2.1-4.9), and R² of 0.992. Precision study using 5 whole blood samples across 20 analyzers showed %CV ranging from 0.8% to 3.1%.

Technological Characteristics

Single-use disc constructed of polymethylmethacrylate and ABS plastic. Employs enzymatic colorimetric assay. Sensing via optical system measuring color intensity at 37°C. Reagents provided as lyophilized beads with liquid diluent. Dimensions: 8 cm diameter. Standalone operation on Piccolo xpress Chemistry Analyzer. Calibration via disc-specific bar code.

Indications for Use

Indicated for the quantitative determination of triglycerides in capillary heparinized whole blood to aid in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, lipid metabolism disorders, or endocrine disorders.

Regulatory Classification

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.

Predicate Devices

• Roche Cobas Triglycerides Test (k893973)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k120664

B. Purpose for Submission:
Modification of a previously cleared device (k023639) to add a new matrix (capillary whole blood)

C. Measurand:
Triglycerides

D. Type of Test:
Quantitative, Colorimetric

E. Applicant:
Abaxis Inc.

F. Proprietary and Established Names:
Piccolo Triglycerides – Capillary Test System

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JGY | Class I, meets limitations of exemptions per 21 CFR 862.9 (c)(4) | 21 CFR 862.1705 Triglyceride test system | Clinical Chemistry (75) |

H. Intended Use:

1. Intended use(s):
Please see indication use below.

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2. Indication(s) for use:

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.

3. Special conditions for use statement(s):

For prescription use

4. Special instrument requirements:

Piccolo xpress Chemistry Analyzer

I. Device Description:

The Piccolo Triglycerides – Capillary Test System is composed of an 8 cm diameter single-use device constructed from three ultrasonically welded injection molded parts. The base and middle layers are formed of polymethylmethacrylate plastic and create the chambers, cuvettes, and passageways for processing the whole blood and mixing the resulting heparinized plasma with diluent and reagents. The top layer, referred to as the bar code ring, is molded from ABS (acrylonitrile, butadiene, and styrene) plastic. The bar code ring is imprinted with a bar code containing disc-specific calibration information and also functions to trap small blood spills, preventing contamination of the analyzer, and to protect the disc optical surfaces from fingerprints.

In the center of the disc there is a molded high-density polyethylene plastic container holding approximately 480 µL of diluent. The diluent container is sealed with polyethylene-laminated foil. Spherical lyophilized reagent beads are placed in the cuvettes during disc manufacture. Cuvettes are made in five different depths. As part of the optical system, the specific depth, or pathlength, is chosen to compliment the reagent sensitivity and analyte concentrations of each test.

The test is performed by means of an enzymatic reaction that leads to a change in color. The measurement of the intensity of the color is directly proportional to the concentration of triglycerides in the sample.

Upon completion of the analysis, the disc, containing the diluted heparinized plasma and blood cells, may be placed back into its foil pouch and is disposed of in a biohazard container.

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J. Substantial Equivalence Information:

1. Predicate device name(s):
Roche Cobas Triglycerides Test

2. Predicate 510(k) number(s):
k893973

3. Comparison with predicate:
| | Piccolo Triglycerides – Capillary Test on Abaxis Chemistry Analyzer (Candidate Device – k120664) | Roche Triglycerides Test on the Cobas 6000 Analyzer (Predicate – k893973) |
| --- | --- | --- |
| Intended Use | Quantitative analysis of Triglycerides | Same |
| Methodology | Enzymatic endpoint reaction | Same |
| Sample Type | Lithium heparinized capillary whole blood, | Lithium heparin and potassium EDTA plasma and serum |
| Dynamic Range Lower Limit | 20 mg/dL | 8.85 mg/dL |
| Reagents | Dry test-specific reagent beads and liquid diluent; reconstitution performed by analyzer | Liquid reagent |
| Temperature of Reaction | 37°C | Same |
| Calibration | Bar code with factory calibrated lot specific data | Calibrated periodically using calibrators supplied by vendor |
| Assay Range | 20–500 mg/dL | 8.85–885 mg/dL |
| Testing Environment | Professional use | Same |
| Sample Size | Approx 100 μL | 2 μL |

K. Standard/Guidance Document Referenced (if applicable):
CLSI EP09-A2- IR Method of comparison and bias estimation using patient samples 07/2010

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CLSI H04-A6 – Procedures and devices for the collection of diagnostic capillary blood specimens 09/2008

L. Test Principle:

The Piccolo Triglycerides – Capillary Test System will initially be contained on the Lipid Panel – Capillary Reagent Disc. The disc is designed to separate a heparinized whole blood sample into plasma and blood cells when run on the Abaxis analyzer. This is achieved automatically within the analyzer without operator intervention. 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. The acceptable sample that may be run on the Piccolo Lipid Panel – Capillary Reagent Disc is heparinized whole blood from capillary (fingerstick) collection.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Point of care precision was previously established in k023639.

Additional precision studies were performed using 5 whole blood samples over a 3-hour time frame using at least 4 different analyzers for each of 7 time points. A total of 20 analyzers were used. The table below summarizes the data.

Summary of Whole Blood Precision

| Sample 1 | mg/dL |
| --- | --- |
| Average | 210.3 |
| sd | 1.9 |
| %CV | 0.9 |
| Sample 2 | mg/dL |
| Average | 78.3 |
| sd | 2.4 |
| %CV | 3.1 |
| Sample 3 | mg/dL |
| Average | 232.1 |
| sd | 2.4 |
| %CV | 1.0 |

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b. Linearity/assay reportable

| Average | 82.7 |
| --- | --- |
| sd | 2.3 |
| %CV | 2.8 |
| Sample 5 | mg/dL |
| --- | --- |
| Average | 219.0 |
| sd | 1.9 |
| %CV | 0.8 |

range:

Previously established in

k023639

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Previously established in k023639

d. Detection limit:

Previously established in k023639

e. Analytical specificity:

Previously established in k023639

f. Assay cut-off:

Not applicable

# 2. Comparison studies:

a. Method comparison with predicate device:

Roche Triglycerides Test (k893973) was used as the predicate method, using recommended applications and procedures on a Roche Cobas 6000 analyzer. Five hundred eighty eight capillary (fingerstick) samples were assayed in parallel by both the test and predicate methods and the results compared by Deming regression. The studies were performed at three point-of-care sites. The range tested was 36 to 496 mg/dL which spans the assay range of 20-500 mg/dL. No samples were altered (spiked or diluted). Data for each site and combined data are shown below:

Site 1:

| Parameters | Statistics |
| --- | --- |
| Piccolo Triglycerides – Capillary: Singlicate Values, N | 201 |
| Roche Triglycerides Assay: Average of Duplicates, N | 201 |
| Piccolo Triglycerides – Capillary: Mean | 170.5 |
| Roche Triglycerides Assay: Mean | 173.7 |
| Piccolo Triglycerides – Capillary: Std. Dev. | 97.5 |

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| Roche Triglycerides Assay: Std. Dev | 100.2 |
| --- | --- |
| Piccolo Triglycerides – Capillary: Range of Samples | 42 - 496 |
| Roche Triglycerides Assay: Range of Samples | 39.0 – 528.0 |
| Parameters (Roche on X Axis) | Linear Regression | Deming Regression |
| --- | --- | --- |
| N | 201 | 201 |
| Slope (95% CI) | 0.97 (0.96 to 0.98) | 0.97 (0.96 to 0.99) |
| Intercept (95% CI) | 1.8 (0.0 to 3.6) | 1.5 (-0.7 to 3.6) |
| Correlation Coefficient (R2) | 0.996 | 0.996 |
| Std. Error of the Estimate (SEE) | 6.4 | 6.4 |

Calculated Recovery of the Abaxis Triglycerides - Capillary Assay

| | Predicate Device Concentration mg/dL | Calculated Piccolo Recovery from Linear Regression Data Above mg/dL | Bias mg/dL | % Bias |
| --- | --- | --- | --- | --- |
| Piccolo Triglycerides - Capillary | 150 | 147.3 | -2.7 | -1.8% |
| | 200 | 195.8 | -4.2 | -2.1% |

Site 2:

| Parameters | Statistics |
| --- | --- |
| Piccolo Triglycerides – Capillary: Singlicate Values, N | 191 |
| Roche Triglycerides Assay: Average of Duplicates, N | 191 |
| Piccolo Triglycerides – Capillary: Mean | 156.4 |
| Roche Triglycerides Assay: Mean | 158.2 |
| Piccolo Triglycerides – Capillary: Std. Dev. | 90.6 |
| Roche Triglycerides Assay: Std. Dev | 94.6 |
| Piccolo Triglycerides – Capillary: Range of Samples | 44 - 479 |

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| Roche Triglycerides Assay: Range of Samples | 41.0 – 498.5 |
| --- | --- |
| Parameters (Roche on X Axis) | Linear Regression | Deming Regression |
| --- | --- | --- |
| N | 191 | 191 |
| Slope (95% CI) | 0.95 (0.94 to 0.97) | 0.96 (0.94 to 0.97) |
| Intercept (95% CI) | 5.3 (3.2 to 7.3) | 4.8 (2.4 to 7.2) |
| Correlation Coefficient (R²) | 0.994 | 0.994 |
| Std. Error of the Estimate (SEE) | 7.4 | 7.4 |

Calculated Recovery of the Abaxis Triglycerides – Capillary Assay

| | Predicate Device Concentration mg/dL | Calculated Piccolo Recovery from Linear Regression Data Above mg/dL | Bias mg/dL | % Bias |
| --- | --- | --- | --- | --- |
| Piccolo Triglycerides - Capillary | 150 | 147.8 | -2.2 | -1.5% |
| | 200 | 195.3 | -4.7 | -2.4% |

Site 3:

| Parameters | Statistics |
| --- | --- |
| Piccolo Triglycerides – Capillary: Singlicate Values, N | 196 |
| Roche Triglycerides Assay: Average of Duplicates, N | 196 |
| Piccolo Triglycerides – Capillary: Mean | 139 |
| Roche Triglycerides Assay: Mean | 140.2 |
| Piccolo Triglycerides – Capillary: Std. Dev. | 72.3 |
| Roche Triglycerides Assay: Std. Dev | 75.3 |
| Piccolo Triglycerides – Capillary: Range of Samples | 36 - 437 |
| Roche Triglycerides Assay: Range of Samples | 33.5 – 447.5 |

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| Parameters (Roche on X Axis) | Linear Regression | Deming Regression |
| --- | --- | --- |
| N | 196 | 196 |
| Slope (95% CI) | 0.95 (0.93 to 0.97) | 0.96 (0.94 to 0.98) |
| Intercept (95% CI) | 5.6 (2.8 to 8.4) | 4.5 (1.9 to 7.1) |
| Correlation Coefficient (R2) | 0.982 | 0.982 |
| Std. Error of the Estimate (SEE) | 9.4 | 9.4 |

Calculated Recovery of the Abaxis Triglycerides - Capillary Assay

| | Predicate Device Concentration mg/dL | Calculated Piccolo Recovery from Linear Regression Data Above mg/dL | Bias mg/dL | % Bias |
| --- | --- | --- | --- | --- |
| Piccolo Triglycerides - Capillary | 150 | 148.1 | -1.9 | -1.3% |
| | 200 | 195.6 | -4.4 | -2.2% |

Standard linear regression analysis was used for estimation of the slope, intercept, and correlation coefficient of the combined data in accordance with CLSI EP9-A2. Deming regression analysis was also performed as shown below.

Combined data:

| Parameters (Roche on X Axis) | Linear Regression | Deming Regression |
| --- | --- | --- |
| N | 588 | 588 |
| Slope (95% CI) | 0.96 (0.95 to 0.97) | 0.96 (0.96 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 |

# b. Matrix comparison:

This submission is for capillary whole blood from finger stick. Matrix comparison previously established in k023639.

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3. Clinical studies:

a. Clinical Sensitivity:
Not applicable

b. Clinical specificity:
Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:

Normal < 150 mg/dL (< 1.70 mmol/L)
Borderline High 150-199 mg/dL (5.17-6.18 mmol/L)
High 200-499 mg/dL (2.26-5.64 mmol/L)
Very High > 500 mg/dL (> 5.65 mmol/L)

National Cholesterol Education Program Expert Panel. Third report of National Cholesterol Education Program (NCEP) Expert Panel and Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (ATP III). NIH Publication. Bethesda, MD: National Heart, Lung and Blood Institute. 2002

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.