PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM
Device Facts
| Record ID | K130200 |
|---|---|
| Device Name | PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM |
| Applicant | Abaxis, Inc. |
| Product Code | CHH · Clinical Chemistry |
| Decision Date | Feb 15, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1175 |
| Device Class | Class 1 |
Intended Use
The Piccolo Total Cholesterol - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of total cholesterol in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein disorders.
Device Story
Piccolo Total Cholesterol - Capillary Test System uses reagent discs to process lithium heparinized capillary whole blood samples. Device separates plasma from blood cells; meters plasma and diluent; mixes with dry reagent beads; performs enzymatic endpoint reaction. Analyzer monitors chemical reactions at 37°C. Used in clinical labs or point-of-care locations by professionals. Provides quantitative total cholesterol results to assist clinicians in diagnosing and treating cholesterol and lipoprotein disorders. System utilizes factory-calibrated, lot-specific data via barcode.
Clinical Evidence
Bench testing only. Linearity established across 20-520 mg/dL range (r=0.999). Precision studies (n=160) showed CVs of 1.3-1.5% (within-run) and 2.2-2.6% (total). Method comparison against Roche Cholesterol assay (n=639) demonstrated strong correlation (R2=0.989) with a slope of 0.97 and intercept of 1.23 in Deming regression. Accuracy confirmed via CRMLN certification.
Technological Characteristics
Enzymatic endpoint reaction; 37°C reaction temperature; dry reagent beads with liquid diluent; factory calibration via barcode; lithium heparinized capillary whole blood sample; 20-520 mg/dL assay range; professional use environment.
Indications for Use
Indicated for in vitro quantitative determination of total cholesterol in capillary (fingerstick) heparinized whole blood. Used for diagnosis and treatment of disorders involving excess cholesterol and lipid/lipoprotein disorders in clinical laboratory or point-of-care settings.
Regulatory Classification
Identification
A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
Related Devices
- K023642 — PICCOLO TOTAL CHOLESTEROL TEST SYSTEM · Abaxis, Inc. · Jan 24, 2003
- K023640 — PICCOLO HDL TEST SYSTEM · Abaxis, Inc. · Jan 24, 2003
- K982118 — CARESIDE ANALYZER · Exigent Diagnostics, Inc. · Jul 24, 1998
- K023639 — PICCOLO TRIGLYCERIDES TEST SYSTEM · Abaxis, Inc. · Jan 24, 2003
Submission Summary (Full Text)
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ABAXIS
3240 Whipple Road, Union City, CA 94587 Phone 510 . 675-6500 Fax 510 . 441-6150
### FEB 1 5 2013
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.
K130200 The assigned 510(k) number is: _
#### 1. Applicant Information:
| Date Prepared: | February 8, 2013 |
|----------------|-------------------------------------------|
| Name: | Abaxis, Inc. |
| Address: | 3240 Whipple Road<br>Union City, CA 94587 |
| Contact Person: | Dennis M. Bleile, PhD |
|-----------------|-----------------------|
| Phone Number: | (510) 675-6515 |
| Fax Number: | (510) 405-8871 |
#### 2. Device Information:
| Classification | Class I- Reserved (point-of-care) |
|----------------------|---------------------------------------------------|
| Trade Name: | Piccolo® Total Cholesterol -Capillary Test System |
| Classification Name: | Total Cholesterol Test system |
| | 862.1175 |
#### 3. Identification 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 SE Determination | | |
| Cobas Cholesterol<br>Gen.2 | Roche Diagnostics<br>Indianapolis, IN | K031824 | 7/09/2003 | | |
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#### 4. Description of the Device:
The Piccolo® Lipid Panel - Capillary Reagent Disc (which contains the Piccolo® Total Cholesterol - 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.
#### 5. Statement of Intended Use:
The Piccolo Total Cholesterol - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of total cholesterol in capillary (fingerstick) heparinized whole blood in a clinical faboratory setting or point-of-care location.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein disorders.
#### Summary of the Technological Characteristics of the New Device in હ. Comparison to those of the Predicate Device:
Table 1 outlines the technological characteristics of the Piccolo® Total Cholesterol -Capillary Test System in comparison to the legally marketed predicate device.
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Table 1: Specification Comparison for Piccolo Total Cholesterol – Capillary Test System and the Roche Total Cholesterol Test on the Cobas 6000 Analyzer
| | Piccolo Total Cholesterol -<br>Capillary Test on Abaxis<br>Chemistry Analyzer | Roche Total Cholesterol Test<br>on the Cobas 6000 Analyzer |
|------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Intended Use | Quantitative analysis of Total<br>Cholesterol | Quantitative analysis of Total<br>Cholesterol |
| Methodology | Enzymatic endpoint reaction | Enzymatic endpoint reaction |
| Sample Type | Lithium heparinized capillary whole<br>blood | Lithium and potassium heparinized<br>plasma and serum |
| Dynamic Range<br>Lower Limit | 20 mg/dL | 3.86 mg/dL |
| Reagents | Dry test-specific reagent beads<br>and liquid diluent; reconstitution<br>performed by analyzer | Liquid reagent |
| Temperature of<br>Reaction | 37°C | 37°C |
| Calibration | Bar code with factory<br>calibrated lot specific data | Calibrated periodically using<br>calibrators supplied by vendor |
| Assay Range | 20 - 520 mg/dL | 3.86 - 800 mg/dL |
| Testing Environment | Professional use | Professional use |
| Sample Size | Approx 100 µL | 2 µL |
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#### 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® Total Cholesterol - Capillary Test System. This device is for the addition of capillary sampling on the previously cleared device K023642.
#### Linearity:
The dynamic range of the Piccolo® Total Cholesterol - Capillary Test System is from 20 to 520 mg/dL. This was established using samples across the measuring range, see previously cleared submission K023642. Testing was done using a total of 20 Piccolo analyzers to ensure that the recoveries were not instrument-specific.
| | Total Cholesterol -<br>Capillary |
|-----------------------------|----------------------------------|
| Slope | 0.989 |
| Intercept | 19.7 |
| Correlation Coefficient (r) | 0.999 |
#### Table 2: Summary of Linearity
#### Precision:
Precision studies were designed to evaluate within-run and total precision of total Cholesterol included on the Piccolo® Lipid Panel Reagent Disc when run on the Abaxis analyzer.
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### Table 3: Within-Run and Total Precision of Total Cholesterol Assayed on the Abaxis Analyzer
| | Within-Run<br>(n =160) | Total<br>(n =160) |
|----------------------------------|------------------------|-------------------|
| <b>Total Cholesterol (mg/dL)</b> | | |
| Serum 1 | | |
| Mean | 223.7 | 223.7 |
| SD | 3.0 | 5.7 |
| %CV | 1.3 | 2.6 |
| Serum 2 | | |
| Mean | 202.2 | 202.2 |
| SD | 3.1 | 4.4 |
| %CV | 1.5 | 2.2 |
Table 4: Whole Blood Precision for Total Cholesterol Assayed on the Abaxis Analyzer: Five fresh whole blood samples were tested seven times on four analyzers over a period of three hours; a total of 20 analyzers were used.
#### Total Cholesterol (mg/dL)
| | Sample 1 | Sample 2 | Sample 3 | Sample 4 | Sample 5 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|----------|----------|----------|----------|
| Mean | 210.8 | 216.8 | 239.1 | 184.2 | 236.2 |
| SD | 3.6 | 3.1 | 3.8 | 3.2 | 3.6 |
| %CV | 1.7 | 1.4 | 1.6 | 1.7 | 1.5 |
| ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ | 28 | 28 | 28 | 28 | 28 |
| | | | | | |
| | | | | | |
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### Method Comparison:
### Table 5: Method Comparison Data for Total Cholesterol Assayed by the Abaxis Piccolo Total Cholesterol - Capillary Test System and the Roche Cholesterol Test - Site 1
| Parameters | Statistics |
|-------------------------------------------------------------|--------------|
| Piccolo Total Cholesterol - Capillary: Singlicate Values, N | 216 |
| Roche Cholesterol Assay: Average of Duplicates, N | 216 |
| Piccolo Total Cholesterol - Capillary: Mean | 186.5 |
| Roche Cholesterol Assay: Mean | 190.6 |
| Piccolo Total Cholesterol - Capillary: Std. Dev. | 53.6 |
| Roche Cholesterol Assay: Std. Dev | 55.3 |
| Piccolo Total Cholesterol - Capillary: Range of Samples | 21 - 283 |
| Roche Cholesterol Assay: Range of Samples (Plasma) | 23.5 - 289.5 |
| Parameters (Roche on X Axis) | Linear Regression | Deming Regression |
|----------------------------------|----------------------|----------------------|
| N | 216 | 216 |
| Slope (95% CI) | 0.97 (0.95 to 0.98) | 0.97 (0.96 to 0.98) |
| Intercept (95% CI) | 2.42 (-0.10 to 4.95) | 1.57 (-0.63 to 3.78) |
| Correlation Coefficient (R2) | 0.991 | 0.991 |
| Std. Error of the Estimate (SEE) | 5.2 | 5.2 |
Abaxis «
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#### Table 6: Method Comparison Data for Total Cholesterol Assayed by the Abaxis Piccolo Total Cholesterol - Capillary Test System and the Roche Cholesterol Test - Site 2
| Parameters | Statistics |
|--------------------------------------------------------------|------------|
| Piccolo Total Cholesterol - Capillary: Singlicate Values, N | 210 |
| Roche Cholesterol Assay: Average of Duplicates, N | 210 |
| Piccolo Total Cholesterol - Capillary: Mean | 185.9 |
| Roche Cholesterol Assay: Mean | 190.8 |
| Piccolo Total Cholesterol - Capillary: Std. Dev. | 56.0 |
| Roche Cholesterol Assay: Std. Dev | 58.1 |
| Piccolo Total Cholesterol - Capillary: Range of Samples | 21 - 412 |
| Roche Cholesterol Assay: Range of Samples (Plasma) | 24 - 442.5 |
| Parameters (Roche on X Axis) | Linear Regression | Deming Regression |
|----------------------------------|---------------------|----------------------|
| N | 210 | 210 |
| Slope (95% CI) | 0.96 (0.95 to 0.97) | 0.96 (0.95 to 0.98) |
| Intercept (95% CI) | 2.83 (0.28 to 5.37) | 1.99 (-1.08 to 5.07) |
| Correlation Coefficient (R2) | 0.991 | 0.991 |
| Std. Error of the Estimate (SEE) | 5.4 | 5.4 |
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### Table 7: Method Comparison Data for Total Cholesterol Assayed by the Abaxis Piccolo Total Cholesterol – Capillary Test System and the Roche Cholesterol Test - Site 3
| Parameters | Statistics |
|--------------------------------------------------------------|--------------|
| Piccolo Total Cholesterol - Capillary: Singlicate Values, N | 213 |
| Roche Cholesterol Assay: Average of Duplicates, N | 213 |
| Piccolo Total Cholesterol - Capillary: Mean | 184.9 |
| Roche Cholesterol Assay: Mean | 190.9 |
| Piccolo Total Cholesterol - Capillary: Std. Dev. | 51.2 |
| Roche Cholesterol Assay: Std. Dev | 52.9 |
| Piccolo Total Cholesterol - Capillary: Range of Samples | 22 - 320 |
| Roche Cholesterol Assay: Range of Samples (Plasma) | 23.5 - 340.5 |
| Parameters (Roche on X Axis) | Linear Regression | Deming Regression |
|----------------------------------|----------------------|----------------------|
| N | 213 | 213 |
| Slope (95% CI) | 0.96 (0.95 to 0.98) | 0.97 (0.95 to 0.98) |
| Intercept (95% CI) | 1.30 (-1.73 to 4.33) | 0.09 (-2.48 to 2.65) |
| Correlation Coefficient (R2) | 0.987 | 0.987 |
| Std. Error of the Estimate (SEE) | 6.0 | 6.0 |
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#### Table 8: Method Comparison Data for Total Cholesterol Assayed by the Abaxis Piccolo Total Cholesterol - Capillary Test System and the Roche Cholesterol Test - Combined Data
| Parameters | Statistics |
|-------------------------------------------------------------|--------------|
| Piccolo Total Cholesterol - Capillary: Singlicate Values, N | 639 |
| Roche Cholesterol Assay: Average of Duplicates, N | 639 |
| Piccolo Total Cholesterol - Capillary: Mean | 185.8 |
| Roche Cholesterol Assay: Mean | 190.8 |
| Piccolo Total Cholesterol - Capillary: Std. Dev. | 53.5 |
| Roche Cholesterol Assay: Std. Dev | 55.4 |
| Piccolo Total Cholesterol - Capillary: Range of Samples | 21 - 412 |
| Roche Cholesterol Assay: Range of Samples (Plasma) | 23.5 - 442.5 |
| Parameters (Roche on X Axis) | Linear Regression | Deming Regression |
|----------------------------------|---------------------|----------------------|
| N | 639 | 639 |
| Slope (95% CI) | 0.96 (0.95 to 0.97) | 0.97 (0.96 to 0.98) |
| Intercept (95% CI) | 2.20 (0.64 to 3.76) | 1.23 (-0.29 to 2.75) |
| Correlation Coefficient (R2) | 0.989 | 0.989 |
| Std. Error of the Estimate (SEE) | 5.6 | 5.6 |
#### 8. Accuracy
Accuracy of the Piccolo method for Cholesterol was established by completing the certification process of the CRMLN.
#### 9. Conclusions
The clinical and non-clinical tests performed using the Piccolo® Total Cholesterol -Capillary Test System, when run on the Piccolo® xpress Chemistry Analyzer, demonstrate that the test 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/9/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines extending from its body, resembling flowing ribbons or streams. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue
Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Public Health Service
February 15, 2013
Abaxis, Inc. c/o Dennis M. Bleile, Ph.D. 3240 Whipple Road Union City, CA 94587
Re: k130200
Trade/Device Name: Piccolo® Total Cholesterol - Capillary Test System Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: I, meets limitations of exemptions per 21 CFR 862.9 (c)(9) Product Code: CHH Dated: January 25, 2013 Received: January 28, 2013
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for
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Page 2-Dr. Bleile
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Carol C. Benson for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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## Indications for Use Form
510(k) Number (if known):
Device Name: Piccolo® Total Cholesterol - Capillary Test System
Indications for Use:
The Piccolo Total Cholesterol - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of total cholesterol in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein disorders.
Prescription Use × (Part 21 CFR 801 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 Diagnostics and Radiological Health (OIR)
# Ruth A. @hesler
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K130200 510(k) =
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