(86 days)
The Piccolo Total Cholesterol Test System used with the Piccolo Point-of-Care Chemistry Analyzer is intended for the in vitro quantitative determination of total cholesterol in heparinized whole blood, heparinized plasma, or serum 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 Reagent Disc (which contains the Piccolo® Total Cholesterol 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. Alternately, the disc may also be used with serum.
Here's a breakdown of the acceptance criteria and study information for the Piccolo® Total Cholesterol Test System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for slope, intercept, or correlation coefficient. Instead, it relies on demonstrating comparable performance to the predicate device. However, we can infer some performance metrics from the reported data.
| Performance Metric | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (Piccolo® Total Cholesterol Test System) |
|---|---|---|
| Linearity | ||
| Slope | Close to 1.0 (indicating proportional readings) | 0.989 |
| Intercept | Close to 0.0 (indicating minimal constant bias) | 19.7 |
| Correlation Coefficient (r) | Close to 1.0 (indicating strong linear relationship) | 0.999 |
| Precision (Within-Run) | ||
| %CV (Serum 1) | Low %CV | 1.3% |
| %CV (Serum 2) | Low %CV | 1.5% |
| Precision (Total) | ||
| %CV (Serum 1) | Low %CV | 2.6% |
| %CV (Serum 2) | Low %CV | 2.2% |
| Method Comparison (vs. Predicate) | ||
| Correlation Coefficient (r) | Close to 1.0 (indicating strong agreement) | 0.997 (Linear Regression), 0.997 (Deming Regression) |
| Slope (Linear Regression) | Close to 1.0 | 1.079 |
| Intercept (Linear Regression) | Close to 0.0 | -17.1 |
| Slope (Deming Regression) | Close to 1.0 | 1.083 |
| Intercept (Deming Regression) | Close to 0.0 | -17.9 |
| Std. Error of Estimate (SEE) | Low | 4.5 |
2. Sample Size Used for the Test Set and Data Provenance
- Linearity & Precision Test Sample Size:
- Linearity: The document shows a slope, intercept, and correlation coefficient, but does not explicitly state the number of samples used for the linearity study.
- Precision:
- Within-Run: n = 160 (for each serum sample type, so likely 320 total measurements involving repetition)
- Total: n = 160 (for each serum sample type, so likely 320 total measurements involving repetition)
- Sample Type Comparison Test Sample Size: Samples from 20 different patients. Each sample type (serum, heparinized plasma, heparinized whole blood) was tested in quadruplicate.
- Method Comparison Test Sample Size: 174 data points (n*) for both the Piccolo CHOL Test System and the Bayer Cholesterol Assay. Since patient samples were run in duplicate, this means approximately 87 patient samples were used (n/2).
- Data Provenance: Not explicitly stated (e.g., country of origin). However, given Abaxis, Inc. is in Union City, CA, and the FDA review is addressed to "Dr. Bleile, Ph.D. Director of Assay Development Abaxis, Inc. 3240 Whipple Road Union City, CA 94587," it is highly probable the studies were conducted in the United States. The studies appear to be prospective as they were specifically designed and conducted for the purpose of demonstrating substantial equivalence for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a diagnostic test for measuring total cholesterol, an objective biochemical marker. The "ground truth" for the test set is established by the reference method (Bayer Cholesterol-RA Assay) and the quantitative nature of the chemical reactions, rather than by expert readers or interpreters.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is an objective quantitative assessment, not dependent on human interpretation requiring adjudication. Performance is compared to a predicate device and established linearity/precision targets.
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 is typically performed for image-based diagnostic devices where human readers interpret images, and the AI's role is to assist or replace human interpretation. The Piccolo® Total Cholesterol Test System is an automated in vitro diagnostic device for quantitative chemical analysis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are for the standalone performance of the Piccolo® Total Cholesterol Test System. The device is designed for automated quantitative analysis, and its performance (linearity, precision, method comparison) is assessed as an algorithm-only measurement.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of the Piccolo® Total Cholesterol Test System is primarily established through:
- Comparison to a legally marketed predicate device: The Bayer Cholesterol-RA Assay, which serves as a clinical standard.
- Known concentrations: For linearity studies, a range of samples with known or precisely measured concentrations would be used to assess the device's ability to accurately measure across its assay range.
- Replicate measurements: For precision studies, repeated measurements of the same samples establish reproducibility.
- Clinical samples: Patient samples are used for method comparison to reflect real-world variability.
Essentially, the ground truth is reference method comparison and established analytical performance metrics (linearity, precision) rather than pathology, expert consensus, or outcomes data in the traditional sense.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" or "test set" in the context of machine learning. This device is a biochemical analyzer, not
an AI/ML-based diagnostic algorithm that requires a training phase with a dedicated dataset. The device's calibration involves "Bar code with factory calibrated lot specific data" which is a form of calibration/initial setup, but not "training" in the AI sense.
9. How the Ground Truth for the Training Set was Established
Not applicable. As per point 8, there is no "training set" in the context of AI/ML for this device. The accuracy of the factory calibration would be established through laboratory reference methods and quality control procedures during manufacturing.
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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 |
Device Information: 2.
| Classification | Class I |
|---|---|
| Trade Name: | Piccolo® Total Cholesterol 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 | Manufacturer | 510(k) Number | Date of SE Determination |
|---|---|---|---|
| CholesterolAssay-RA | Bayer Diagnostics | K802743*(Ames Sera-PakCholesterolReagent Kit) | 12/10/80 |
Presumptive K number. NOTE: The predicate device is currently known as Bayer * Diagnostics Cholesterol Reagent. Since Bayer has undergone a series of mergers and other business transactions (e.g., Bayer, Technicon, Miles, Ames), the exact regulatory "lineage" is difficult to determine.
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Description of the Device: 4.
The Piccolo® Lipid Panel Reagent Disc (which contains the Piccolo® Total Cholesterol 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. Alternately, the disc may also be used with serum.
5. Statement of Intended Use:
The Piccolo® Lipid Panel Reagent Disc (contains the Piccolo® Total Cholesterol Test System) use with the Piccolo® Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of total cholesterol in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-ofcare 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® Total Cholesterol Test System in comparison to the legally marketed predicate device.
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Specification Comparison for Piccolo Total Cholesterol (CHOL) Test Table 1: System versus Bayer Cholesterol-RA Assay
| Piccolo Cholesterol Assay onAbaxis Point-of-CareChemistry Analyzer | Bayer Cholesterol-RA Assay onHitachi 917 Analyzer | |
|---|---|---|
| Intended Use | Quantitative analysis ofcholesterol | Quantitative analysis ofcholesterol |
| Methodology | Enzymatic endpoint reaction | Enzymatic endpoint reaction |
| Sample Type | Heparinized whole blood,heparinized plasma, andserum | Heparinized plasma and serum |
| Sensitivity | 0.00294 A per mg/dL or 0.113 Aper mmol/L; 20 mg/dL | 0.0012 A per mg/dL or 0.0462 Aper mmol/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 - 520 mg/dL | 0 - 500 mg/dL |
| Testing Environment | Professional use | Professional use |
| Sample Size | Approx 100 µL | 2.7 µL |
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 Test System.
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Linearity:
Table 2: Summary of Linearity
| Total Cholesterol | ||
|---|---|---|
| Slope | 0.989 | |
| Intercept | 19.7 | |
| Correlation Coefficient (r) | 0.999 |
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 Piccolo® Point-of-Care Chemistry Analyzer.
Table 3: Within-Run and Total Precision of Total Cholesterol Assayed on the Piccolo® Point-of-Care Chemistry 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 |
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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 total cholesterol.
Method Comparison:
| Table 4: Method Comparison Data for Total Cholesterol Assayed on the Using the | ||||
|---|---|---|---|---|
| Abaxis Piccolo® CHOL Assay and the Bayer CHOL Assay |
| Parameters | Statistics | |
|---|---|---|
| Piccolo CHOL Test System | n* | 174 |
| Bayer Cholesterol Assay | n* | 174 |
| Piccolo CHOL Test System | Mean | 202.0 |
| Bayer Cholesterol Assay | Mean | 203.1 |
| Piccolo CHOL Test System | Std. Dev. | 53.5 |
| Bayer Cholesterol Assay | Std. Dev. | 49.4 |
| Piccolo CHOL Test System | Range of Samples | 108 - 342 |
| Bayer Cholesterol Assay | Range of Samples | 115 - 342 |
| Linear Regression | Deming Regression | |
|---|---|---|
| n* | 174 | 174 |
| Slope | 1.079 | 1.083 |
| Intercept | -17.1 | -17.9 |
| Correlation Coefficient (r) | 0.997 | 0.997 |
| Std. Error of the Estimate (SEE) | 4.5 | 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® Total Cholesterol 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 seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, possibly representing water or movement.
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: K023642
Trade/Device Name: Piccolo® Total Cholesterol Test System Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: Class I Product Code: CHH 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
| 510(k) Number (if known): | K023642 |
|---|---|
| --------------------------- | --------- |
Piccolo® Total Cholesterol Test System Device Name:
Intended Use:
The Piccolo Total Cholesterol Test System used with the Piccolo Point-of-Care Chemistry Analyzer is intended for the in vitro quantitative determination of total cholesterol in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
Indications for Use:
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein disorders.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over- The Counter Use (Optional Format 1-2-96)
Sam A. Dor Di Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K003242
§ 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.