TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS

K050799 · Biosite Incorporated · GGN · Jun 29, 2005 · Hematology

Device Facts

• Record ID: K050799
• Device Name: TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS
• Applicant: Biosite Incorporated
• Product Code: GGN · Hematology
• Decision Date: Jun 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The Triage D-Dimer Calibration Verification Controls are to be used with the Triage D-Dimer Test and Triage MeterPlus to verify the calibration of the Triage D-Dimer Test throughout the measurable range. The Triage D-Dimer Controls are assayed materials to be used with the Triage D-Dimer Test and Triage MeterPlus to assist the laboratory in monitoring test performance.

Device Story

Triage D-Dimer Calibration Verification Controls and Triage D-Dimer Controls are liquid quality control materials; composed of EDTA human plasma with preservatives and D-dimer; used with Triage D-Dimer Test and Triage MeterPlus. Calibration verification controls supplied in five levels (A-E); Triage D-Dimer Controls supplied in two levels (1-2). Laboratory personnel use these assayed materials to monitor test performance and verify calibration throughout the measurable range. Product stability maintained at -20 °C or colder.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Liquid control material; EDTA human plasma base with preservatives and D-dimer; stored at -20 °C. Designed for use with Triage MeterPlus. No electronic or software components; purely chemical/biological control material.

Indications for Use

Indicated for use by laboratory professionals as assayed quality control materials to verify calibration and monitor performance of the Triage D-Dimer Test when used with the Triage MeterPlus system.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• Bio-Rad Liquichek™ D-dimer Control Levels 1, 2 and 3 (k032017)

Submission Summary (Full Text)

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## JUN 2 9 2005

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

## Triage D-Dimer Calibration Verification Controls / Triage D-Dimer Controls

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

#### k050799 510(k) Number:

### A. Name and Address of Submitter

| Company Name: | Biosite Incorporated |
|------------------------|-----------------------|
| Address: | 11030 Roselle Street |
| | San Diego, CA 92121 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Rachael S. Williamson |
| Date Summary Prepared: | 6/22/05 |

### B. Device Names

- 1. Trade Name
Triage D-Dimer Calibration Verification Controls / Triage D-Dimer Controls

- 2. Common / Usual Name
Not Applicable

.

#### 3. Classification Name

Plasma, Coagulation Control 21 CFR 864.5425 Class II Product Code: GGN

### C. Predicate Devices

Bio-Rad Liquichek™ D-dimer Control Levels 1, 2 and 3 (k032017)

### D. Device Description and Intended Use

The Triage D-Dimer Calibration Controls are to be used with the Triage D-Dimer Test and Triage MeterPlus to verify the calibration of the Triage D-Dimer Test throughout the measurable range.

The Triage D-Dimer Controls are assayed materials to be used with the Triage D-Dimer Test and Triage MeterPlus to assist the laboratory in monitoring test performance.

### E. Conclusion

The information provided in the premarket notification demonstrates that the Triage D-Dimer Calibration Verification Controls / Triage D-Dimer Controls are substantially equivalent to previously approved predicate devices. The information provided assures

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that the Triage D-Dimer Calibration Verification Controls / Triage D-Dimer Controls are safe and effective for their intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an emblem that appears to be an abstract representation of an eagle or other bird.

JUN 2 9 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Rachael S. Williamson Regulatory Affairs Specialist Biosite Incorporated 11030 Roselle Street San Diego, California 92121

k050799 Re:

Trade/Device Name: Triage D-Dimer Calibration Verification Controls and Triage D-Dimer Controls Regulation Number: 21 CFR § 864.5425 Regulation Name: Plasma coagulation control Regulatory Class: II Product Code: GGN Dated: May 17, 2005 Received: May 18, 2005

Dear Ms. Williamson:

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). 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.

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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 [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,

lobatz Beckerich

Robert L. Becker, Jr., MD, Pa 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): K050799

Device Name: Triage® D-Dimer Test

Indications For Use:

The Triage D-Dimer Calibration Verification Controls are to be used with the The Thage D-Dimer Test and Triage MeterPlus to verify the calibration of the Triage D-Dimor Test throughout the measurable range.

The Triage D-Dimer Controls are assayed materials to be used with the The Thage D-Dimer Test and Triage MeterPlus to assist the laboratory in monitoring test performance.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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

Josephine Bautista

(Division Sign-Øff)

510(k) Number

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Division of Clinical Laboratory Devices
510(k) Number K050799

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