TRIAGE PROTEIN C TEST

K062530 · Biosite Incorporated · GGP · Jan 29, 2007 · Hematology

Device Facts

• Record ID: K062530
• Device Name: TRIAGE PROTEIN C TEST
• Applicant: Biosite Incorporated
• Product Code: GGP · Hematology
• Decision Date: Jan 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Indications for Use

The Triage Protein C Test is a rapid, point-of-care fluorescence immunoassay to be used with the Triage Meters for the rapid, quantitative determination of Protein C in citrated whole blood or plasma specimens in patients with signs and symptoms of sepsis. The test is not intended for use in patients with vitamin K deficiency, DIC, cancers, HIV and liver and renal diseases as these disease conditions have not been evaluated.

Device Story

Triage Protein C Test is a single-use fluorescence immunoassay cartridge used with Triage Meters for point-of-care testing. Input: citrated whole blood or plasma. Operation: murine monoclonal antibodies against Protein C labeled with fluorescent dye bind to Protein C antigen immobilized on solid phase. Meter measures fluorescence to quantify Protein C levels. Output: quantitative result displayed on meter screen or printout in ~15 minutes. Used by healthcare professionals in clinical settings. Built-in positive/negative controls and automatic endpoint detection ensure assay completion. Provides rapid assessment of Protein C levels in septic patients to assist clinical decision-making.

Clinical Evidence

Method comparison study conducted at three independent clinical laboratory sites. 225 split patient samples from individuals with suspected or proven infection, systemic inflammation, and sepsis-induced organ failure were tested using both the Triage Protein C Test and the predicate method. Testing performed in accordance with NCCLS Evaluation Protocol EP9-A2. No specific sensitivity/specificity metrics provided; study focused on method comparison and bias estimation.

Technological Characteristics

Fluorescence immunoassay; murine monoclonal antibodies; immobilized Protein C antigen; stabilizers. Form factor: single-use test cartridge for use with Triage Meter. Energy source: Triage Meter (electronic). Connectivity: standalone meter. Software: includes automatic endpoint detection and internal assay controls.

Indications for Use

Indicated for rapid, quantitative determination of Protein C in citrated whole blood or plasma in patients with signs/symptoms of sepsis. Contraindicated for patients with vitamin K deficiency, DIC, cancers, HIV, or liver/renal diseases.

Predicate Devices

• Asserachrom® Protein C Kit (K854016)

Submission Summary (Full Text)

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#### 510(k) Summary of Safety and Effectiveness B.

# JAN 2 9 2007

### Triage® Protein C Test

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

#### A. Name and Address of Submitter

| Company Name: | Biosite Incorporated |
|------------------------|----------------------------------------------------|
| Address: | 9975 Summers Ridge Road<br>San Diego, CA 92121 |
| Telephone: | [phone] |
| Telefax: | [phone] |
| Contact Person: | Fil V. Buenviaje<br>Manager, Regulatory Compliance |
| Date Summary Prepared: | January 17, 2007 |

#### Device Name and Classification B.

| Trade Name: | Triage® Protein C Test |
|---------------------------|-----------------------------------------------------------------|
| Common Name: | Protein C |
| Classification of Device: | 21 CFR 864.7290.<br>Factor Deficiency Test<br>Product Code: GGP |

#### C. Predicate Device

Asserachrom® Protein C Kit (K854016)

#### D. Device Description

The Triage Protein C Test is a single-use device containing murine monoclonal antibodies against Protein C labeled with a fluorescent dye and purified Protein C antigen immobilized on the solid phase, and stabilizers. Additionally, there are built-in control features that ensure that the test was performed properly and the reagents were functionally active.

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The Test Cartridge is inserted into the Triage Meter and results are measured and displayed on the display screen or printout in approximately 15 minutes. Internal assay controls (positive and negative controls) and automatic endpoint detection technology is used to indicate assay completion.

#### ய் Device Intended Use

The Triage Protein C Test is a rapid, point-of-care fluorescence immunoassay to be used with the Triage Meters for the rapid, quantitative determination of Protein C in citrated whole blood or plasma specimens in patients with signs and symptoms of sepsis. The test is not intended for use in patients with vitamin K deficiency, DIC, cancers, HIV and liver and renal diseases as these disease conditions have not been evaluated.

#### ட் Comparison to Predicate Device

The performance of the Triage Protein C Test was established using samples collected from patients who presented with suspected or proven infection, evidence of systemic inflammation and at least one sepsis-induced organ failure who were enrolled in a previous clinical investigation. Two hundred twenty-five split patient samples were run in the Triage Protein C Test and a predicate method for the purpose of determining if the two methods yield similar results. Testing was conducted at three independent clinical laboratory sites in accordance with NCCLS Evaluation Protocol EP9-A2, Vol. 22, No. 19, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second Edition.

#### G. Conclusion

The information presented in this Premarket Notification demonstrates that the performance of the Triage Protein C Test for use with citrated human blood and plasma is substantially equivalent to the predicate device.

Equivalence was demonstrated using manufactured reagents along with patient and quality control samples with measured Protein C values spanning the reportable range of the assay.

These studies demonstrate the substantial equivalence of the Triage Protein C Test to existing products already marketed for the quantitative determination of Protein C. They further demonstrated the suitability of the product for laboratory and professional use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.

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Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol in the center. The symbol resembles a stylized eagle or bird in flight, composed of curved lines. The overall design is simple and monochromatic.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

BIOSITE Incorporated C/O Fil V. Buenviaje 9975 Summers Ridge Road San Diego, California 92121

Re: k062530

Trade/Device Name: Triage Protein C Test Regulation Number: 21 CFR 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: Class II Product Code: GGP Dated: August 28, 2006 Received: August 29, 2006

JAN 2 9 2007

### Dear Mr. Buenviaje

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. Drue, 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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

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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 Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Robert L. Becker, Jr., MD, PhD

Director Division of Immunology and Hematology 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):

K062530

Device Name:

Triage® Protein C Test

Indications for Use:

The Triage Protein C Test is a rapid, point-of-care fluorescence immunoassay to be used with the Triage Meters for the rapid, quantitative determination of Protein C in citrated whole blood or plasma specimens in patients with signs and symptoms of sepsis. The test is not intended for use in patients with vitamin K deficiency, DIC, cancers, HIV and liver and renal diseases as these disease conditions have not been evaluated.

X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use (Per 21 CFR 807 Subpart C)

(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Suphine Bautista
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of

510(k) K062530