PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM

K091052 · Abaxis, Inc. · DCN · Jan 15, 2010 · Immunology

Device Facts

• Record ID: K091052
• Device Name: PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM
• Applicant: Abaxis, Inc.
• Product Code: DCN · Immunology
• Decision Date: Jan 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

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.

Device Story

Piccolo® C-Reactive Protein (CRP) Test System is a point-of-care diagnostic tool used with the Piccolo xpress™ Chemistry Analyzer. It processes lithium heparinized whole blood, plasma, or serum samples. The system utilizes single-use reagent discs containing dry reagent beads (mouse monoclonal anti-CRP antibody-coated latex and goat anti-CRP antibody). The analyzer separates plasma from whole blood, meters sample and diluent, and mixes them with reagents. The principle of operation is an enhanced latex-agglutination turbidimetric immunoassay; CRP in the sample binds to antibody-coated latex particles, causing agglutination and increased turbidity. The analyzer measures the change in absorbance at 630 nm, which is directly proportional to CRP concentration. Results are provided to clinicians to assist in evaluating infection, tissue injury, and inflammatory disorders. The system is designed for clinical laboratory or point-of-care settings and is operated by healthcare professionals.

Clinical Evidence

Bench testing only. Linearity study showed correlation coefficient of 0.997. Precision studies (n=40 to 80 per level) demonstrated total CVs ranging from 2.2% to 9.8% across serum, plasma, and control samples. Sample type comparability established for lithium heparinized whole blood, plasma, and serum.

Technological Characteristics

Enhanced latex-agglutination turbidimetric immunoassay. Reagents: dry test-specific beads and liquid diluent. Active ingredients: anti-CRP antibody-coated latex particles and anti-CRP goat antibody. Reaction temperature: 37°C. Calibration: bar-coded factory-calibrated lot-specific data. Sample volume: ~100 µL. Assay range: 5.0–200.0 mg/L.

Indications for Use

Indicated for the quantitative determination of C-Reactive Protein (CRP) in lithium heparinized whole blood, lithium heparinized plasma, or serum to aid in the evaluation of infection, tissue injury, and inflammatory disorders in conjunction with other clinical findings. Not for high sensitivity CRP measurement.

Regulatory Classification

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.

Predicate Devices

• Synchron® Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) (K070626)

Submission Summary (Full Text)

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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 Road<br>Union City, CA 94587 |

Contact Person: Dennis M. Bleile, PhD Phone Number: [phone] Fax Number: [phone]

#### 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)<br>Number | Date of SE<br>Determination |
| High Sensitivity<br>C-Reactive Protein<br>Synchron LX20 | Beckman Coulter,<br>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 LX20<br>Chemistry System K070626 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Intended Use | Quantitative analysis of<br>C-Reactive Protein | Quantitative analysis of<br>C-Reactive Protein |
| Methodology | Enhanced latex-agglutination<br>turbidimetric immunoassay | Particle-agglutination rate<br>turbidimetric immunoassay |
| Sample Type | Lithium heparinized whole blood,<br>lithium heparinized plasma, and serum | Plasma and serum |
| Dynamic Range,<br>Lower Limit | 5 mg/L | 0.2 mg/L |
| Reagents | Dry test-specific reagent beads and<br>liquid diluent; reconstitution performed<br>by analyzer | Liquid reagents |
| | Active ingredients: | Active ingredients: |
| | Anti-CRP antibody-coated latex<br>particles (latex particle-bound<br>mouse monoclonal anti-CRP<br>antibody) | Anti-CRP antibody-coated<br>particles (particle-bound<br>goat and mouse anti-CRP<br>antibody) |
| | Anti-CRP goat antibody | |
| Temperature of<br>Reaction | 37°C | 37°C |
| Calibration | Bar code with factory<br>calibrated lot specific data | Single-point adjusted, pre-<br>determined calibration curve |
| Assay Range | 5.0 - 200.0 mg/L | 0.2 - 80.0 mg/L<br>(60 - 380.0 mg/L ORDAC*) |
| Testing Environment | Professional use | Professional use |
| Sample Size | Approximately 100 µL | 20 ul<br>(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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### 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<br>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)<br>Mean | 8.3 | 8.3 |
| SD | 0.70 | 0.81 |
| %CV | 8.4 | 9.8 |
| Serum Level 2 (n = 40)<br>Mean | 8.1 | 8.1 |
| SD | 0.49 | 0.51 |
| %CV | 6.1 | 6.3 |
| Serum Level 3 (n = 40)<br>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 [phone]. 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 [phone] or [phone] 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