(50 days)
The Piccolo HDL - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of HDL in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location.
Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
The Piccolo® Lipid Panel – Capillary Reagent Disc (which contains the Piccolo® HDL - 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 breakdown of the acceptance criteria and study information for the Abaxis Piccolo HDL - Capillary Test System, based on the provided text:
Acceptance Criteria and Device Performance
The provided document doesn't explicitly state numerical "acceptance criteria" in a table format alongside the performance. Instead, it presents the results of various validation tests, implying that the device's performance within these studies was deemed acceptable for substantial equivalence. The predicate devices' specifications provide the implicit benchmarks for comparison.
Here's a table summarizing the reported device performance, with implicit acceptance criteria derived from the comparisons and intended use:
| Test / Characteristic | Acceptance Criteria (Implicit, based on predicates & intended use) | Reported Device Performance (Piccolo® HDL - Capillary Test System) |
|---|---|---|
| Intended Use | Quantitative HDL determination in clinical/POC setting. | Quantitative HDL in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location. |
| Methodology | Enzymatic colorimetric end-point test. Similar to predicate. | Hybrid enzymatic colorimetric end-point test, making use of dextran/sulfate precipitation, centrifugation, and PEG-modified enzymes. |
| Sample Type | Appropriate for intended use (e.g., whole blood, plasma, serum). | Lithium heparinized capillary whole blood. |
| Dynamic Range | ≥ 15 mg/dL lower limit. | 15 mg/dL. |
| Assay Range | Similar to predicate, covering relevant clinical range. | 15 - 100 mg/dL. |
| Linearity (Slope) | Close to 1. | 0.983 |
| Linearity (Intercept) | Close to 0. | 0.5 |
| Linearity (Correlation Coefficient, r) | Close to 1. | 0.997 |
| Precision (Within-Run %CV) | Acceptable for clinical use, comparable to predicate. | Serum 1 (Mean 55.3 mg/dL): 2.6%Serum 2 (Mean 38.0 mg/dL): 3.5% |
| Precision (Total %CV) | Acceptable for clinical use, comparable to predicate. | Serum 1 (Mean 55.3 mg/dL): 3.5%Serum 2 (Mean 38.0 mg/dL): 4.3% |
| Method Comparison (Slope vs. Roche HDL Test) | Close to 1 (indicating agreement). | 0.99 (95% CI: 0.97 to 1.01) (Linear Regression)1.01 (95% CI: 0.99 to 1.03) (Deming Regression) |
| Method Comparison (Intercept vs. Roche HDL Test) | Close to 0 (indicating agreement). | -1.6 (95% CI: -2.4 to -0.8) (Linear Regression)-2.6 (95% CI: -3.4 to -1.7) (Deming Regression) |
| Method Comparison (Correlation Coefficient, R²) | Close to 1 (indicating strong correlation). | 0.962 |
| Method Comparison (Std. Error of the Estimate, SEE) | Low (indicating good agreement). | 2.7 |
Study Details
2. Sample Size Used for the Test Set and Data Provenance
- Linearity Study: The sample size for the linearity study is not explicitly stated in terms of number of unique patient samples, but the statistical results (Slope, Intercept, Correlation Coefficient) indicate multiple data points were analyzed across the dynamic range.
- Precision Study:
- Sample Size: n = 160 (for both within-run and total precision for each serum level). This likely refers to 160 individual measurements for each of the two serum levels or 160 replicates of each serum level.
- Data Provenance: Not explicitly stated, but the samples are referred to as "Serum 1" and "Serum 2," suggesting laboratory-prepared or pooled serum samples. No mention of country of origin or retrospective/prospective collection is provided for these particular samples.
- Method Comparison Study:
- Sample Size: N = 559.
- Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. The samples are "analyzed by the Abaxis Piccolo HDL - Capillary Test System and the Roche HDL Test," suggesting human samples. The range of samples is 21 - 93 mg/dL for Piccolo and 23 - 92.5 mg/dL for Roche, indicating real-world patient samples covering a clinical range.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This device is an in-vitro diagnostic (IVD) chemistry analyzer for quantitative determination of HDL. For such devices, "ground truth" is typically established by:
- Reference laboratory methods,
- Predicate devices (clinically accepted and legally marketed), or
- NIST (National Institute of Standards and Technology) traceable standards.
In this case, the ground truth for the performance studies was established through comparison with a legally marketed predicate device (Roche HDL Test), which serves as the reference for method comparison. The precision and linearity studies use internal quality controls or characterized samples.
Therefore, the concept of "experts" establish ground truth in the same way as for imaging or clinical diagnosis is not directly applicable here. The "experts" would be the manufacturers and developers of the reference/predicate methods, and the laboratory professionals performing the analyses.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret data, and there's a need to resolve discrepancies. Since this study concerns the performance of an automated IVD device comparing its results to a reference method (or itself for precision/linearity), no human adjudication method was employed or necessary. The quantitative results are compared statistically.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results (e.g., radiology AI). The Piccolo® HDL - Capillary Test System is an automated quantitative chemical analyzer, not a device requiring human interpretation in its output.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Yes, this was a standalone performance study in the context of an IVD device. The "algorithm" here is the device's integrated system of reagents, fluidic handling, and photometric detection, which automatically produces a quantitative HDL value. The performance metrics (linearity, precision, method comparison) evaluate the device's output without human intervention influencing the final analytical result. Human involvement is limited to sample collection, loading, and initiating the test.
7. Type of Ground Truth Used
- Linearity and Precision Studies: The ground truth for these studies relies on characterized samples or quality controls with known analyte concentrations. For linearity, serial dilutions of a high-concentration sample are used, with the expected values serving as the truth. For precision, control materials with specified concentrations are repeatedly measured.
- Method Comparison Study: The ground truth was established by comparison to a legally marketed predicate device: the Roche HDL Test (specifically, the "Roche HDL Test: Average of Duplicates"). The predicate device's results are considered the reference against which the new device's performance is measured.
8. Sample Size for the Training Set
No training set is explicitly mentioned or relevant in the context of this 510(k) submission. This device is a chemical analyzer based on established enzymatic calorimetric principles. It does not utilize machine learning or AI models that require a "training set" in the conventional sense. The "training" of the device involves its internal calibration (factory calibrated lot-specific data via bar code) and manufacturing processes to ensure it accurately measures the analyte.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no "training set" in the AI/ML sense. The device's calibration and manufacturing are based on established chemical principles and metrology standards, ensuring the accuracy of its measurements across its assay range.
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APR 2 4 2012
3240 Whipple Road, Union City, CA 94587 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: | March 2, 2012 |
|---|---|
| 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) 405-8871
Device Information: 2.
Classification Class I Piccolo® HDL - Capillary Test System Trade Name:
Classification Name: HDL Test system 862.1475
3. Identification of Legally Marketed Device to which the Submitter Claims Equivalence:
The following table identifies the legally marketed devices to which Abaxis claims equivalence:
| Predicate Device | |||
|---|---|---|---|
| Predicate Device | Manufacturer | 510(k) Number | Date of SE Determination |
| Piccolo® HDL TestSystem | Abaxis | K023640 | 1/24/2003 |
| Cobas® HDL-Cholesterol Plus 3rdGeneration | Roche DiagnosticsIndianapolis, IN | K033610 | 12/05/2003 |
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Summary of Safety and Effectiveness (continued)
4. Description of the Device:
The Piccolo® Lipid Panel – Capillary Reagent Disc (which contains the Piccolo® HDL - 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 HDL - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of HDL in capillary (fingerstick) heparinized whole blood 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® HDL - Capillary Test System in comparison to the legally marketed predicate device.
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Piccolo® HDL (High Density Lipoprotein Cholestero
- Capillary Test System
Summary of Safety and Effectiveness (continued
able 1: Specification Comparison for Piccolo HDL – Capillary Test System, Piccolo HDL Test System, and the Roche HD
est on the Cobas 6000 Analyzer
| Piccolo HDL - Capillary Test System on Abaxis Chemistry Analyzer | Piccolo HDL Test System on Abaxis Chemistry Analyzer | Roche Diagnostics Cobas® HDL-Cholesterol Plus 3rd Generation Test | |
|---|---|---|---|
| Intended Use | Quantitative analysis of HDL | Quantitative analysis of HDL | Quantitative analysis of HDL |
| Methodology | Hybrid enzymatic colorimetric end-point test, making use of dextran/sulfate precipitation, centrifugation, and PEG-modified enzymes | Hybrid enzymatic colorimetric end-point test, making use of dextran/sulfate precipitation, centrifugation, and PEG-modified enzymes | Homogeneous enzymatic colorimetric end-point test, making use of dextran/sulfate suspension and PEG-modified enzymes |
| Sample Type | Lithium heparinized capillary whole blood | Lithium heparinized whole blood, heparinized plasma, and serum | Lithium heparin and potassium EDTA plasma and serum |
| Dynamic Range Lower Limit | 15 mg/dL | 15 mg/dL | 3 mg/dL |
| Reagents | Dry test-specific reagent beads and liquid diluent; reconstitution performed by analyzer | Dry test-specific reagent beads and liquid diluent; reconstitution performed by analyzer | Liquid reagents |
| Temperature of Reaction | 37°C | 37°C | 37°C |
| Calibration | Bar code with factory calibrated lot specific data | Bar code with factory calibrated lot specific data | Calibrated periodically using calibrators supplied by vendor |
| Assay Range | 15 - 100 mg/dL | 15 - 100 mg/dL | 3 - 120 mg/dL |
| Testing Environment | Professional use | Professional use | Professional use |
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Summary of Safety and Effectiveness (continued)
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® HDL Test System.
Linearity:
| Table 2: Summary of Linearity | ||
|---|---|---|
| HDL | ||
| Slope | 0.983 | |
| InterceptCorrelation Coefficient (r) | 0.50.997 | |
Precision:
Precision studies were designed to evaluate within-run and total precision of HDL included on the Piccolo® Lipid Panel Reagent Disc when run on the Piccolo® Pointof-Care Chemistry Analyzer.
Table 3: Within-Run and Total Precision of HDL Assayed on the Piccolo Point-of-Care Chemistry Analyzer
| Within-Run | Total | |
|---|---|---|
| (n =160) | (n =160) | |
| HDL (mg/dL) | ||
| Serum 1 | ||
| Mean | 55.3 | 55.3 |
| SD | 1.4 | 1.9 |
| %CV | 2.6 | 3.5 |
| Serum 2 | ||
| Mean | 38.0 | 38.0 |
| SD | 1.3 | 1.6 |
| %CV | 3.5 | 4.3 |
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Summary of Safety and Effectiveness (continued)
Method Comparison:
Table 4: Method Comparison Data for HDL Assayed by the Abaxis Piccolo HDL -Capillary Test System and the Roche HDL. Test
| Parameters | Statistics |
|---|---|
| Piccolo HDL - Capillary: Singlicate Values, N | 559 |
| Roche HDL Test: Average of Duplicates, N | 559 |
| Piccolo HDL - Capillary: Mean | 47.2 |
| Roche HDL Test: Mean | 49.3 |
| Piccolo HDL - Capillary: Std. Dev. | 13.9 |
| Roche HDL Test: Std. Dev | 13.8 |
| Piccolo HDL - Capillary: Range of Samples | 21 - 93 |
| Roche HDL Test: Range of Samples | 23 - 92.5 |
| Parameters (Roche on X Axis) | Linear Regression | Deming Regression |
|---|---|---|
| N | 559 | 559 |
| Slope (95% CI) | 0.99 (0.97 to 1.01) | 1.01 (0.99 to 1.03) |
| Intercept | -1.6 (-2.4 to -0.8) | -2.6 (-3.4 to -1.7) |
| Correlation Coefficient (R2) | 0.962 | 0.962 |
| Std. Error of the Estimate (SEE) | 2.7 | 2.7 |
Conclusions 8.
The clinical and non-clinical tests performed using the Piccolo® HDL – 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
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Abaxis Inc. c/o Dennis Bleile, Ph.D. 3240 Whipple Road Union City, CA 94587
Re: K120662
Trade/Device Name: Piccolo® HDL Capillary Test System Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: . Class I, meets limitations of exemptions per 21 CFR 862.9 (c)(9) Product Code: JHM 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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
APR 2 4 2012
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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,
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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INDICATIONS FOR USE STATEMENT 12.0
Indications for Use
K120662 510(k) Number (if known):
Piccolo® HDL - Capillary Test System Device Name:
Indications for Use:
The Piccolo HDL - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of HDL in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location.
Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
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) K120662
Page 1 of 1
(Optional Format 1-2-96)
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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.