(277 days)
Not Found
No
The summary describes a chemistry analyzer that performs quantitative determination of CRP using chemical reactions and optical monitoring. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
Explanation: This device is an in vitro diagnostic (IVD) test system used to quantitatively determine CRP levels, which aids in the evaluation of conditions, but it does not directly treat or alleviate a disease or condition.
Yes
The device is described as a "C-Reactive Protein Test System" intended for "in vitro quantitative determination of CRP concentration" to "aid in the evaluation of infection, tissue injury, and inflammatory disorders in conjunction with other laboratory and clinical findings." This directly indicates its use in diagnosing or aiding in the diagnosis of certain conditions by providing quantitative measurements of a biomarker.
No
The device description clearly outlines a physical reagent disc and an analyzer, indicating it is a hardware-based system for in vitro diagnostic testing, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is "intended to be used for the in vitro quantitative determination of CRP concentration...". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Measurement of Biomarkers: The device measures the concentration of C-Reactive Protein (CRP) in biological samples (whole blood, plasma, or serum). Measuring biomarkers in biological samples is a core function of IVDs.
- Clinical Purpose: The test results "aid in the evaluation of infection, tissue injury, and inflammatory disorders in conjunction with other laboratory and clinical findings." This indicates a clinical purpose for the test, which is typical for IVDs used in diagnosis, monitoring, or prognosis.
- Device Description: The description details how the device processes biological samples and uses reagents to initiate chemical reactions for measurement. This process is consistent with how IVDs function.
- Care Setting: The intended use in a "clinical laboratory setting or point of care location" further supports its use in a healthcare context for diagnostic purposes.
Therefore, based on the provided information, the Piccolo® C-Reactive Protein Test System clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
C-Reactive Protein test results aid in the evaluation of infection, tissue injury, and inflammatory disorders in conjunction with other laboratory and clinical findings.
Product codes
DCN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory setting or point of care location.
Professional use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Linearity:
Slope: 1.037
Intercept: -0.764
Corr. Coefficient: 0.997
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.
Within-Run and Total Precision for C-Reactive Protein, Assayed on the Piccolo xpress Chemistry Analyzer:
Serum Level 1 (n = 80): Mean = 8.3 mg/L (Within-Run and Total), SD = 0.70 (Within-Run), 0.81 (Total), %CV = 8.4 (Within-Run), 9.8 (Total)
Serum Level 2 (n = 40): Mean = 8.1 mg/L (Within-Run and Total), SD = 0.49 (Within-Run), 0.51 (Total), %CV = 6.1 (Within-Run), 6.3 (Total)
Serum Level 3 (n = 40): Mean = 8.8 mg/L (Within-Run and Total), SD = 0.54 (Within-Run and Total), %CV = 6.2 (Within-Run and Total)
C-Reactive Protein (mg/L):
Plasma 1 (n = 40): Mean = 34.5 (Within-Run and Total), SD = 1.04 (Within-Run), 1.09 (Total), %CV = 3.0 (Within-Run), 3.2 (Total)
Plasma 2 (n = 40): Mean = 105.5 (Within-Run and Total), SD = 2.06 (Within-Run), 2.30 (Total), %CV = 1.9 (Within-Run), 2.2 (Total)
Control Level 1 (n = 80): Mean = 33.0 (Within-Run and Total), SD = 1.21 (Within-Run), 2.12 (Total), %CV = 3.7 (Within-Run), 6.4 (Total)
Control Level 2 (n = 80): Mean = 108.0 (Within-Run and Total), SD = 1.88 (Within-Run), 3.14 (Total), %CV = 1.7 (Within-Run), 2.9 (Total)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Road |
| Union 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 SE | ||
| Determination | |||
| High Sensitivity | |||
| C-Reactive Protein | |||
| Synchron 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
1
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.
2
Summary of Safety and Effectiveness (continued)
Table 1: Specification Comparison: Piccolo C-Reactive Protein Test System & Predicate Device
| | Piccolo xpress Chemistry Analyzer | Beckman Synchron LX20
Chemistry System K070626 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Intended Use | Quantitative analysis of
C-Reactive Protein | Quantitative analysis of
C-Reactive Protein |
| Methodology | Enhanced latex-agglutination
turbidimetric immunoassay | Particle-agglutination rate
turbidimetric 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 and
liquid diluent; reconstitution performed
by analyzer | Liquid reagents |
| | Active ingredients: | Active ingredients: |
| | Anti-CRP antibody-coated latex
particles (latex particle-bound
mouse monoclonal anti-CRP
antibody) | Anti-CRP antibody-coated
particles (particle-bound
goat and mouse anti-CRP
antibody) |
| | Anti-CRP goat antibody | |
| Temperature of
Reaction | 37°C | 37°C |
| Calibration | Bar code with factory
calibrated 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.
3
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-Reactive
Protein |
|-------------------|-----------------------|
| 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 |
4
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.
5
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
6
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
7
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