(18 days)
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.
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.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Piccolo® Total Cholesterol - Capillary Test System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|---|
| Linearity/Dynamic Range | Lower Limit | Not explicitly stated as an acceptance criterion, but established as 20 mg/dL | 20 mg/dL |
| Upper Limit | Not explicitly stated as an acceptance criterion, but established as 520 mg/dL | 520 mg/dL | |
| Slope (compared to reference method) | Not explicitly stated, but typically expected to be close to 1 | 0.989 | |
| Intercept (compared to reference method) | Not explicitly stated, but typically expected to be close to 0 | 19.7 | |
| Correlation Coefficient (r) | Not explicitly stated, but typically >0.99 for good linearity | 0.999 | |
| Precision | Within-Run %CV (Low Concentration e.g. Serum 1) | Not explicitly stated, but typically <5% for many analytes | 1.3% (for mean 223.7 mg/dL) |
| Within-Run %CV (High Concentration e.g. Serum 2) | Not explicitly stated, but typically <5% for many analytes | 1.5% (for mean 202.2 mg/dL) | |
| Total %CV (Low Concentration e.g. Serum 1) | Not explicitly stated, but typically <5% or <10% for many analytes | 2.6% (for mean 223.7 mg/dL) | |
| Total %CV (High Concentration e.g. Serum 2) | Not explicitly stated, but typically <5% or <10% for many analytes | 2.2% (for mean 202.2 mg/dL) | |
| Whole Blood Precision %CV | Not explicitly stated, but typically <5% or <10% for many analytes | 1.4% - 1.7% across 5 samples (Mean range: 184.2 - 239.1 mg/dL) | |
| Method Comparison | Correlation Coefficient (R²) | Not explicitly stated, but typically >0.95 or >0.98 for good correlation | Site 1: 0.991 (Linear & Deming), Site 2: 0.991 (Linear & Deming), Site 3: 0.987 (Linear & Deming), Combined: 0.989 (Linear & Deming). These very high R² values indicate excellent correlation. |
| Slope (Linear Regression) | Not explicitly stated, but expected to be close to 1 within a tight CI | Site 1: 0.97 (0.95 to 0.98 CI), Site 2: 0.96 (0.95 to 0.97 CI), Site 3: 0.96 (0.95 to 0.98 CI), Combined: 0.96 (0.95 to 0.97 CI). These are all very close to 1. | |
| Intercept (Linear Regression) | Not explicitly stated, but expected to be close to 0 within a tight CI | Site 1: 2.42 (-0.10 to 4.95 CI), Site 2: 2.83 (0.28 to 5.37 CI), Site 3: 1.30 (-1.73 to 4.33 CI), Combined: 2.20 (0.64 to 3.76 CI). These are all close to 0, often including 0 in their respective 95% CIs. | |
| Accuracy | CRMLN Certification | Certification by CRMLN (Cholesterol Reference Method Laboratory Network) | Accuracy was established by completing the certification process of the CRMLN. (This implies the device meets the accuracy standards required for CRMLN certification.) |
Note: The document implicitly defines successful performance by demonstrating strong correlation, linearity, and acceptable precision in comparison to the predicate device and established reference methods. Explicit numerical acceptance criteria (e.g., "R² must be >0.98") are not stated in this summary, but the reported results clearly meet the standards for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Linearity Test: Samples across the measuring range were used. The specific number of distinct samples isn't given, but testing was done on 20 Piccolo analyzers. The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but it would typically be prospective for device validation.
- Precision Test:
- Serum Samples for Within-Run and Total Precision: 160 measurements for each serum level (Serum 1 & Serum 2).
- Whole Blood Precision: 5 fresh whole blood samples were tested 7 times each on 4 analyzers over 3 hours. This means a total of 5 * 7 = 35 measurements per analyzer, and 35 * 4 = 140 measurements in total for whole blood precision (though the table states 28 for each sample). The document also states "a total of 20 analyzers were used" for this specific test, which introduces some ambiguity on the total number of data points if each sample was run on all 20 analyzers.
- The data provenance is not explicitly stated.
- Method Comparison Test:
- Site 1: 216 samples
- Site 2: 210 samples
- Site 3: 213 samples
- Combined Data: 639 samples
- The data provenance (e.g., country of origin, retrospective or prospective) for these clinical samples is not explicitly mentioned in the provided text. Based on the context of a 510(k) submission, these would typically be prospectively collected samples from a clinical laboratory or point-of-care setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the device's performance (specifically for method comparison) was established by comparison to the Roche Cholesterol Test on the Cobas 6000 Analyzer.
For accuracy, the device was certified by the CRMLN (Cholesterol Reference Method Laboratory Network). This implies adherence to established reference methods and standards, which are overseen by expert bodies but doesn't involve individual experts establishing ground truth for each test case in the same way as, for example, image interpretation. The "experts" are essentially the established reference methods and organizations that define accurate cholesterol measurement.
4. Adjudication Method for the Test Set
Not applicable. This device is an in-vitro diagnostic (IVD) quantitative test system, not an interpretive device like an AI-powered diagnostic imaging tool that would require human expert adjudication of results. The "ground truth" is analytical (e.g., reference assay results, certified reference materials).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study design is typically used for interpretive diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance to measure the AI's impact on human performance. This device is an automated quantitative test system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies presented (Linearity, Precision, Method Comparison) represent the standalone performance of the Piccolo® Total Cholesterol - Capillary Test System as an algorithm/device-only system. Its output is a quantitative value, not an interpretation requiring human input for its direct result.
7. The Type of Ground Truth Used
- For Linearity, Precision, and Method Comparison: The ground truth was established by comparison to:
- Reference materials or samples of known concentration (for linearity, precision).
- A legally marketed predicate device: The Roche Cholesterol Test on the Cobas 6000 Analyzer (for method comparison).
- For Accuracy: The ground truth was established by "completing the certification process of the CRMLN" (Cholesterol Reference Method Laboratory Network). CRMLN certification signifies that the method is traceable to the Centers for Disease Control and Prevention (CDC) reference method for cholesterol.
8. The Sample Size for the Training Set
The provided document describes validation studies (linearity, precision, method comparison) for a predicate-based 510(k) submission for an IVD device. It does not mention any "training set" in the context of machine learning. The device is a chemical analyzer using enzymatic endpoint reactions, not an AI/ML algorithm that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/ML device, the concept of a "training set" and its associated ground truth establishment is not applicable as described in the document. The device's operational parameters (e.g., reagent formulations, reaction conditions, calibration) would be developed and optimized through standard analytical chemistry and engineering practices, not machine learning training. Calibration is done via a barcode with factory-calibrated lot-specific data.
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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 RoadUnion 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 CholesterolGen.2 | Roche DiagnosticsIndianapolis, 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 -Capillary Test on AbaxisChemistry Analyzer | Roche Total Cholesterol Teston the Cobas 6000 Analyzer | |
|---|---|---|
| Intended Use | Quantitative analysis of TotalCholesterol | Quantitative analysis of TotalCholesterol |
| Methodology | Enzymatic endpoint reaction | Enzymatic endpoint reaction |
| Sample Type | Lithium heparinized capillary wholeblood | Lithium and potassium heparinizedplasma and serum |
| Dynamic RangeLower Limit | 20 mg/dL | 3.86 mg/dL |
| Reagents | Dry test-specific reagent beadsand liquid diluent; reconstitutionperformed by analyzer | Liquid reagent |
| Temperature ofReaction | 37°C | 37°C |
| Calibration | Bar code with factorycalibrated lot specific data | Calibrated periodically usingcalibrators 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 -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(n =160) | Total(n =160) | |
|---|---|---|
| Total Cholesterol (mg/dL) | ||
| 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) =
Page 1 of _ 1 _ _ _ _
§ 862.1175 Cholesterol (total) test system.
(a)
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.(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.