(277 days)
The Piccolo® C-Reactive Protein Test System used with the Piccolo xpress™ Chemistry Analyzer is intended to be used for the in vitro quantitative determination of CRP concentration in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point of care location. This test is not intended for high sensitivity CRP measurement.
C-Reactive Protein test results aid in the evaluation of infection, tissue injury, and inflammatory disorders in conjunction with other laboratory and clinical findings.
The Piccolo MetLyte Plus CRP Reagent Disc (which contains the Piccolo C-Reactive Protein Test System) is designed for lithium heparinized whole blood, lithium heparinized plasma, and serum, only. The disc meters the required quantity of sample and diluent, mixes the sample with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted sample mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.
This document describes the Abaxis Piccolo C-Reactive Protein (CRP) Test System and demonstrates its substantial equivalence to a legally marketed predicate device (Beckman Synchron LX20 Chemistry System K070626). The information provided focuses on the performance characteristics of the Abaxis device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" for linearity or precision in a numerical format that would represent target values. Instead, it presents the results of linearity and precision studies. The implicit acceptance is that these results demonstrate performance comparable to clinical expectations for such a device and are sufficient to prove substantial equivalence to the predicate device.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Abaxis Piccolo CRP Test System) |
|---|---|---|
| Linearity | Demonstrate a strong linear relationship across the assay range. | Slope: 1.037 |
| Intercept: -0.764 | ||
| Correlation Coefficient: 0.997 | ||
| Precision (Within-Run & Total) | Demonstrate acceptable repeatability and reproducibility for different CRP levels in serum and plasma. | C-Reactive Protein (mg/L) |
| Serum Level 1 (n=80) | ||
| Mean: 8.3, SD: 0.70 (Within-Run), 0.81 (Total), %CV: 8.4 (Within-Run), 9.8 (Total) | ||
| Serum Level 2 (n=40) | ||
| Mean: 8.1, SD: 0.49 (Within-Run), 0.51 (Total), %CV: 6.1 (Within-Run), 6.3 (Total) | ||
| Serum Level 3 (n=40) | ||
| Mean: 8.8, SD: 0.54 (Within-Run), 0.54 (Total), %CV: 6.2 (Within-Run), 6.2 (Total) | ||
| Plasma 1 (n=40) | ||
| Mean: 34.5, SD: 1.04 (Within-Run), 1.09 (Total), %CV: 3.0 (Within-Run), 3.2 (Total) | ||
| Plasma 2 (n=40) | ||
| Mean: 105.5, SD: 2.06 (Within-Run), 2.30 (Total), %CV: 1.9 (Within-Run), 2.2 (Total) | ||
| Control Level 1 (n=80) | ||
| Mean: 33.0, SD: 1.21 (Within-Run), 2.12 (Total), %CV: 3.7 (Within-Run), 6.4 (Total) | ||
| Control Level 2 (n=80) | ||
| Mean: 108.0, SD: 1.88 (Within-Run), 3.14 (Total), %CV: 1.7 (Within-Run), 2.9 (Total) | ||
| Sample Type Comparability | Demonstrate comparable results across lithium heparinized whole blood, lithium heparinized plasma, and serum. | Comparability was established for CRP. |
Study Proving Device Meets Criteria:
The study conducted to prove the device meets these criteria is a series of clinical and non-clinical tests summarized in Tables 2 and 3 and described under Section 7: "Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence."
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 patient samples. It reports a slope, intercept, and correlation coefficient, which are derived from a series of measurements across a range of concentrations.
- Precision Studies:
- Serum Level 1: n = 80
- Serum Level 2: n = 40
- Serum Level 3: n = 40
- Plasma 1: n = 40
- Plasma 2: n = 40
- Control Level 1: n = 80
- Control Level 2: n = 80
- Sample Type Comparison Study: The document states "A study was conducted to examine and compare results for lithium heparinized whole blood, lithium heparinized plasma, and serum," but does not explicitly provide the number of samples used in this comparison.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a clinical laboratory test system, such studies are typically prospective analytical validation studies using prepared samples or patient samples collected for the purpose of the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. For an invitro diagnostic (IVD) device like a CRP test, "ground truth" is typically established by reference methods or validated comparative methods ("predicate device" in this case) rather than by expert consensus on qualitative interpretation. The "ground truth" for the test set is considered to be the quantitative values obtained from a reference method or the predicate device.
4. Adjudication Method for the Test Set:
This information is not applicable/provided for this type of IVD device. Adjudication methods (like 2+1, 3+1) are common in studies involving expert interpretation of images or other subjective data. For a quantitative test like CRP, the "adjudication" is essentially the comparison of results against a reference method or the predicate device with predefined statistical measures.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, a MRMC comparative effectiveness study was not done. MRMC studies are typically performed for devices that involve human interpretation (e.g., radiologists reading images) to assess the impact of a device on reader performance. This document concerns a fully automated quantitative test system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Yes, a standalone performance evaluation was done. The document focuses exclusively on the analytical performance of the "Piccolo C-Reactive Protein Test System" run on the "Piccolo xpress Chemistry Analyzer" (an automated system). The precision and linearity data presented directly reflect the performance of the device without human interpretation affecting the result. The comparison is between the new device and a predicate device, both being automated quantitative systems.
7. The Type of Ground Truth Used:
The ground truth used for this type of quantitative IVD device is generally based on:
- Comparison to a legally marketed predicate device: The document explicitly states the "Piccolo C-Reactive Protein Test System" is compared to the "Beckman Synchron LX20 Chemistry System K070626". The performance characteristics (e.g., linearity, precision) are evaluated using samples for which the CRP concentration is known or reliably determined by established methods or the predicate device.
- Reference materials/methods: Implicitly, the linearity and precision studies would rely on samples with known or traceable CRP concentrations, potentially established using reference materials or highly accurate reference methods, to assess the accuracy of the device across its measuring range.
8. The Sample Size for the Training Set:
The document does not provide information regarding a "training set" or its sample size. This is typical for analytical validation reports of IVD devices for 510(k) submissions, which focus on analytical performance testing rather than machine learning model development. The device itself is an immunoassay system, not an AI/ML algorithm that requires a separate training set.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" in the context of an AI/ML model, this question is not applicable to the provided document. The "ground truth" for the analytical performance studies (linearity, precision) would be established by reference methods or the performance of the predicate device, as mentioned in point 7.
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JAN 1 5 2010
3240 Whipple Road, Union City, CA 94587 Phone 510 . 675-8500 Fax 510 . 441-6150
Image /page/0/Picture/2 description: The image shows the word "ABAXIS" in a bold, sans-serif font. The letters are black, and the background is white. A black oval shape surrounds the letters "XI" in the word "ABAXIS". The oval shape is slightly tilted to the right.
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: | January 12, 2010 |
|---|---|
| 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 II |
|---|---|
| Trade Name: | Piccolo ® C-Reactive Protein Test System |
- Classification Name: C-Reactive Protein Test system 866.5270
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 SEDetermination |
| High SensitivityC-Reactive ProteinSynchron LX20 | Beckman Coulter,Inc. (Brea, CA) | K070626 | 05/04/07 |
4. Description of the Device:
The Piccolo MetLyte Plus CRP Reagent Disc (which contains the Piccolo C-Reactive Protein Test System) is designed for lithium heparinized whole blood, lithium heparinized plasma, and serum, only. The disc meters the required quantity of sample and diluent, mixes the sample with diluent, and delivers the mixture to the
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Summary of Safety and Effectiveness (continued)
reaction cuvettes along the disc perimeter. The diluted sample mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.
5. Statement of Intended Use:
The Piccolo C-Reactive Protein Test System used with the Piccolo xpress Chemistry Analyzer is intended to be used for the in vitro quantitative determination of CRP concentration in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point of care location. This test is not intended for high sensitivity CRP measurement.
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 C-Reactive Protein Test System in comparison to the legally marketed predicate device.
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Summary of Safety and Effectiveness (continued)
Table 1: Specification Comparison: Piccolo C-Reactive Protein Test System & Predicate Device
| Piccolo xpress Chemistry Analyzer | Beckman Synchron LX20Chemistry System K070626 | |
|---|---|---|
| Intended Use | Quantitative analysis ofC-Reactive Protein | Quantitative analysis ofC-Reactive Protein |
| Methodology | Enhanced latex-agglutinationturbidimetric immunoassay | Particle-agglutination rateturbidimetric immunoassay |
| Sample Type | Lithium heparinized whole blood,lithium heparinized plasma, and serum | Plasma and serum |
| Dynamic Range,Lower Limit | 5 mg/L | 0.2 mg/L |
| Reagents | Dry test-specific reagent beads andliquid diluent; reconstitution performedby analyzer | Liquid reagents |
| Active ingredients: | Active ingredients: | |
| Anti-CRP antibody-coated latexparticles (latex particle-boundmouse monoclonal anti-CRPantibody) | Anti-CRP antibody-coatedparticles (particle-boundgoat and mouse anti-CRPantibody) | |
| Anti-CRP goat antibody | ||
| Temperature ofReaction | 37°C | 37°C |
| Calibration | Bar code with factorycalibrated lot specific data | Single-point adjusted, pre-determined calibration curve |
| Assay Range | 5.0 - 200.0 mg/L | 0.2 - 80.0 mg/L(60 - 380.0 mg/L ORDAC*) |
| Testing Environment | Professional use | Professional use |
| Sample Size | Approximately 100 µL | 20 ul(12 uL ORDAC*) |
- Beckman LX20 has an "Overrange Detection and Correction" for samples that exceed the 80.0 mg/L limit. This is an automated process within the analyzer that retests with a smaller sample volume.
Note: The Beckman system has been cleared for "high sensitivity" measurements, while the Abaxis system is seeking clearance for a "conventional, quantitative CRP" method, only. Still, The Beckman and the Abaxis systems share sufficient test system and performance characteristics so that the Synchron LX20 CRP assay may serve as the legal and functional predicate.
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ﻤ ﻜﺴ
Summary of Safety and Effectiveness (continued)
Brief discussion of the clinical and nonclinical tests relied on for a 7. determination of substantial equivalence.
Tables 2 & 3 summarize the results of clinical and non-clinical tests performed using the Piccolo C-Reactive Protein Test System.
Linearity:
Table 2: Summary of Linearity
| C-ReactiveProtein | |
|---|---|
| Slope | 1.037 |
| Intercept | -0.764 |
| Corr. Coefficient | 0.997 |
Precision:
Precision studies were designed to evaluate within-run and total precision of the C-Reactive Protein Test System when run on the Piccolo xpress Chemistry Analyzer.
Table 3: Within-Run and Total Precision for C-Reactive Protein, Assayed on the Piccolo xpress Chemistry Analyzer
| Analyte | Within-Run | Total |
|---|---|---|
| C-Reactive Protein (mg/L) | ||
| Serum Level 1 (n = 80)Mean | 8.3 | 8.3 |
| SD | 0.70 | 0.81 |
| %CV | 8.4 | 9.8 |
| Serum Level 2 (n = 40)Mean | 8.1 | 8.1 |
| SD | 0.49 | 0.51 |
| %CV | 6.1 | 6.3 |
| Serum Level 3 (n = 40)Mean | 8.8 | 8.8 |
| SD | 0.54 | 0.54 |
| %CV | 6.2 | 6.2 |
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Summary of Safety and Effectiveness (continued)
| Analyte | Within-Run | Total |
|---|---|---|
| C-Reactive Protein (mg/L) | ||
| Plasma 1 (n = 40) | ||
| Mean | 34.5 | 34.5 |
| SD | 1.04 | 1.09 |
| %CV | 3.0 | 3.2 |
| Plasma 2 (n = 40) | ||
| Mean | 105.5 | 105.5 |
| SD | 2.06 | 2.30 |
| %CV | 1.9 | 2.2 |
| Control Level 1 (n = 80) | ||
| Mean | 33.0 | 33.0 |
| SD | 1.21 | 2.12 |
| %CV | 3.7 | 6.4 |
| Control Level 2 (n = 80) | ||
| Mean | 108.0 | 108.0 |
| SD | 1.88 | 3.14 |
| %CV | 1.7 | 2.9 |
Table 3 (continued)
Sample Type Comparison:
A study was conducted to examine and compare results for lithium heparinized whole blood, lithium heparinized plasma, and serum on the Piccolo® xpress Chemistry Analyzer.
Lithium heparinized whole blood, lithium heparinized plasma, and serum comparability was established for CRP.
8. Conclusions
The clinical and non-clinical tests performed for CRP, 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 device identified above.
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002
JAN 15 2010
Abaxis, Inc c/o Dennis M. Bleile Director of Assay Performance & Compliance 3240 Whipple Rd Union City, California 94587
Re: K091052
Trade/Device Name: Piccolo C-reactive Protein (CRP) Test System Regulation Number: 21 CFR §866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: II Product Code: DCN Dated: January 5. 2010 Received: January 7, 2010
Dear Mr. 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
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Page 2 - Dennis M. Bleile
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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/cdrh/industry/support/index.html.
Sincerely yours.
Berne Philip
Maria M. Chan. Ph Director
Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K091052
Piccolo® C-Reactive Protein Test System Device Name:
Intended Use:
The Piccolo® C-Reactive Protein Test System used with the Piccolo xpress™ Chemistry Analyzer is intended to be used for the in vitro quantitative determination of CRP concentration in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point of care location. This test is not intended for high sensitivity CRP measurement.
Indications for Use:
C-Reactive Protein test results aid in the evaluation of infection, tissue injury, and inflammatory disorders in conjunction with other laboratory and clinical findings.
Prescription Use (Per 21 CFR 801.109)
OR
Over- The Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)
Reena Philip
Division Clerk-Off
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety
510(k) K091052
Abaxis Confidential
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).