(86 days)
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.
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.
This document describes the regulatory submission for the Abaxis Piccolo® Triglycerides Test System. The device is a laboratory test system designed to measure triglyceride levels in blood samples.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined set of thresholds. Instead, it presents performance characteristics of the new device and compares them to those of a legally marketed predicate device (Bayer Triglycerides-RA Assay). The underlying acceptance criterion for regulatory approval in this context is "substantial equivalence" to the predicate device, meaning the new device performs as safely and effectively. The tests conducted (linearity, precision, sample type comparison, and method comparison) are standard ways to demonstrate this equivalence for in vitro diagnostic devices.
Below is a table summarizing the reported device performance and comparing it to the characteristics of the predicate device, which implicitly defines the 'acceptance' for a substantially equivalent device.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate Device) | Reported Device Performance (Piccolo® Triglycerides Test System) |
|---|---|---|
| Intended Use | Quantitative analysis of triglycerides | Quantitative analysis of triglycerides |
| Methodology | Enzymatic endpoint reaction | Enzymatic endpoint reaction |
| Sample Type | Heparinized plasma and serum | Heparinized whole blood, heparinized plasma, and serum |
| Sensitivity | 0.99 mA per mg/dL or 0.088 A per mmol/L | 3.82 mA per mg/dL or 0.338 A per mmol/L; 20 mg/dL |
| Reagents | Dry reagents (reconstituted by user prior to use) and liquid reagents | Dry test-specific reagent beads and liquid diluent; reconstitution performed by analyzer |
| Temperature of Reaction | 37°C | 37°C |
| Calibration | Calibrated periodically using calibrators supplied by vendor | Bar code with factory calibrated lot specific data |
| Assay Range | 0 - 500 mg/dL | 20 - 500 mg/dL |
| Testing Environment | Professional use | Professional use |
| Sample Size | 2 µL | Approx 100 µL |
| Linearity (Slope) | (Implied to be close to 1) | 1.000 |
| Linearity (Intercept) | (Implied to be close to 0) | 3.0 |
| Linearity (Correlation Coefficient 'r') | (Implied to be close to 1) | 1.000 |
| Precision (Serum 1, Mean) | (Not specified as a target, but precision is expected) | 206.8 mg/dL (Within-Run & Total) |
| Precision (Serum 1, SD) | (Not specified as a target, but precision is expected) | 4.7 (Within-Run), 5.5 (Total) |
| Precision (Serum 1, %CV) | (Not specified as a target, but precision is expected) | 2.3 (Within-Run), 2.6 (Total) |
| Precision (Serum 2, Mean) | (Not specified as a target, but precision is expected) | 163.7 mg/dL (Within-Run & Total) |
| Precision (Serum 2, SD) | (Not specified as a target, but precision is expected) | 1.8 (Within-Run), 2.4 (Total) |
| Precision (Serum 2, %CV) | (Not specified as a target, but precision is expected) | 1.1 (Within-Run), 1.5 (Total) |
| Method Comparison (Correlation Coefficient 'r') | (Implied to be close to 1 for substantial equivalence) | 0.999 |
| Method Comparison (Slope) | (Implied to be close to 1 for substantial equivalence) | 0.983 (Linear), 0.984 (Deming) |
| Method Comparison (Intercept) | (Implied to be close to 0 for substantial equivalence) | 8.2 (Linear), 8.1 (Deming) |
2. Sample Size Used for the Test Set and the Data Provenance:
- Linearity Study: The sample size for the linearity study is not explicitly stated in terms of number of patient samples, but the results for slope, intercept, and correlation coefficient are provided.
- Precision Study:
- Sample Size: n = 160 for both within-run and total precision for each serum level tested (Serum 1 and Serum 2). This appears to be 160 replicates per serum level, not 160 distinct patient samples.
- Data Provenance: Not specified, but generally, such studies use commercially available control sera or pooled patient samples.
- Sample Type Comparison Study:
- Sample Size: Samples from 20 different patients. Each sample type (serum, heparinized plasma, heparinized whole blood) was tested in quadruplicate.
- Data Provenance: Not specified, presumed to be clinical samples.
- Method Comparison Study:
- Sample Size: n = 172 data points. The document clarifies: "number of patient samples = n/2", meaning 86 unique patient samples were run in duplicate.
- Data Provenance: Not specified, but these are patient samples tested against a predicate device, presumably from a clinical setting. Retrospective or prospective is not specified, but given the nature of the study, it's likely a mix or prospective collection for comparison purposes. No country of origin is mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. For in vitro diagnostic devices like this, the "ground truth" for the test set (patient samples) is typically established by the reference method (the predicate device, in the case of method comparison) or by highly accurate laboratory methods, rather than by human expert consensus or adjudication.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are common in image-based diagnostic studies where human readers interpret results which are then reconciled. For quantitative laboratory tests, the result is a numerical value, and "adjudication" in the traditional sense is not performed on the test results themselves. Method comparison studies statistically compare the new device's numerical results to those of the predicate device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable and therefore not provided. MRMC studies are specific to diagnostic tools that involve human interpretation, often in imaging. The Abaxis Piccolo® Triglycerides Test System is an automated in vitro diagnostic device for quantitative chemical analysis, not an AI-assisted diagnostic tool that involves human reader interpretation for primary diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, the studies presented (Linearity, Precision, Sample Type Comparison, Method Comparison) represent the standalone performance of the Abaxis Piccolo® Triglycerides Test System. The device is designed to operate as an automated system producing a quantitative result without direct human interpretation influencing the measurement itself (beyond sample collection and loading). The studies assess the device's inherent analytical performance.
7. The Type of Ground Truth Used:
For the method comparison study, the predicate device's measurement (Bayer Triglycerides-RA Assay) served as the de facto "ground truth" for comparison to establish substantial equivalence. For linearity, precision, and sample type comparison, the "ground truth" is typically established by the inherent analytical capabilities of the device itself and its ability to consistently and accurately measure known concentrations or produce reproducible results.
8. The Sample Size for the Training Set:
This information is not applicable and therefore not provided. The Abaxis Piccolo® Triglycerides Test System is a chemical analyzer, not a machine learning or AI-based system that requires a "training set" in the computational sense. Its reagents and methods are developed through biochemical and analytical chemistry principles, not by training an algorithm on a dataset.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable due to the nature of the device (see point 8).
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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 RoadUnion 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 | Date of SE Determination |
|---|---|---|---|
| Triglycerides-RAAssay Run on aHitachi 917 ClinicalChemistry Analyzer | Bayer Diagnostics | K854152*(Technicon RASystems forTriglyceridesAnalysis) | 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
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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.
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Specification Comparison for Piccolo Triglycerides (TRIG) Test Table 1: System versus Bayer Triglycerides-RA Assay
| Piccolo Triglycerides Assay onAbaxis Point-of-CareChemistry Analyzer | Bayer Triglycerides-RA Assayon Hitachi 917 Analyzer | |
|---|---|---|
| Intended Use | Quantitative analysis oftriglycerides | Quantitative analysis oftriglycerides |
| Methodology | Enzymatic endpoint reaction | Enzymatic endpoint reaction |
| Sample Type | Heparinized whole blood,heparinized plasma, andserum | Heparinized plasma and serum |
| Sensitivity | 3.82 mA per mg/dL or 0.338 Aper mmol/L; 20 mg/dL | 0.99 mA per mg/dL or 0.088 A permmol/L |
| Reagents | Dry test-specific reagent beadsand liquid diluent; reconstitutionperformed by analyzer | Dry reagents (reconstituted by userprior to use) and liquid reagents |
| Temperature of Reaction | 37°C | 37°C |
| Calibration | Bar code with factorycalibrated lot specific data | Calibrated periodically usingcalibrators 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.
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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 |
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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.
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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).
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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
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INDICATIONS FOR USE STATEMENT 12.0
Indications for Use
K0236334 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Piccolo® Triglycerides Test System Device Name:
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.
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.
(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 |
|---|---|
| --------------- | --------- |
·
§ 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.