TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS

K030088 · Biosite Incorporated · JJY · Jan 17, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030088
• Device Name: TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS
• Applicant: Biosite Incorporated
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are to be used with the Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter to verify the calibration of the Triage® Cardio ProfilER / Triage® Cardiac Panel throughout the measurable range.

Device Story

Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls serve as quality control material for Triage® diagnostic panels; used with Triage® Meter to verify calibration across measurable range. Device consists of control samples prepared in an EDTA-containing matrix. Used in clinical laboratory settings by laboratory personnel to ensure accuracy of cardiac panel testing. Output is a verification of system calibration, allowing healthcare providers to confirm the reliability of patient test results. Benefits include ensuring consistent performance of diagnostic assays, thereby supporting accurate clinical decision-making for cardiac conditions.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Quality control material (assayed/unassayed) for in vitro diagnostic use. Matrix contains EDTA. Designed for use with Triage® Meter and Triage® Cardio ProfilER / Triage® Cardiac Panels. Class II device (21 CFR 862.1660).

Indications for Use

Indicated for use as quality control material to verify the calibration of the Triage® Cardio ProfilER / Triage® Cardiac Panel when used with the Triage® Meter. No specific patient population is described as this is an in vitro diagnostic quality control product.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Triage® Cardiac Calibration Verification Controls (K974827)
• Triage® BNP Calibration Verification Controls (K000231)

Submission Summary (Full Text)

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No30053

JAN 1 7 2003

# 510(k) Summary of Safety and Effectiveness

# Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification 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.

#### 510(k) Number: (To be determined)

#### A. Name and Address of Submitter

| Company Name: | Biosite Incorporated |
|------------------------|--------------------------|
| Address: | 11030 Roselle Street |
| | San Diego, CA 92121 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Jeffrey R. Dahlen, Ph.D. |
| Date Summary Prepared: | 1/7/03 |

#### B. Device Names

- 1. Trade Name
Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls

- 2. Common / Usual Name
Not Applicable

- 3. Classification Name
Quality Control Material (Assayed and Unassayed) 21 CFR 862:1660 Class I Product Code: JJY

#### C. Predicate Devices

Triage® Cardiac Calibration Verification Controls (K974827) Triage® BNP Calibration Verification Controls (K000231)

# D. Device Description and Intended Use

The Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are to be used with the Triage® Cardio ProfilER / Triage® Cardiac

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Panel and Triage® Meter to verify the calibration of the Triage® Cardio ProfilER / Triage® Cardiac Panel throughout the measurable range.

# E. Summary of Comparison Data

The Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are a combination of the two predicate devices. The only difference between the Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls and the predicate devices is that the Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are prepared in a matrix that contains EDTA, while the Triage® Cardiac Calibration Verification Controls are prepared in a matrix that contains heparin.

### F. Conclusion

The information provided in the premarket notification demonstrates that the Triage® Cardio ProfilER / Triaqe® Cardiac Calibration Verification Controls are substantially equivalent to previously approved predicate devices. The information provided assures that the Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are safe and effective for their intended use.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 7 2003

Jeffrev R. Dahlen, Ph.D. Principal Scientist Clinical and Regulatory Affairs Biosite Inc. 11030 Roselle Street San Diego, CA 92121

Re: k030088

Trade/Device Name: Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed). Regulatory Class: Class II Product Code: JJY Dated: January 7, 2003 Received: January 10, 2003

Dear Dr. Dahlen:

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).

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Page 2 -

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 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). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

# K030088

# 510(k) Number (if known): (to be determined)

Device Name: Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls

Indications For Use:

The Triage® Cardio ProfilER / Triage® Cardiac Calibration Verification Controls are to be used with the Triage® Cardio ProfilER / Triage® Cardiac Panel and Triage® Meter to verify the calibration of the Triage® Cardio ProfilER / Triage® Cardiac Panel throughout the measurable range.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jean Looper

Clinical Laboratory Devices
K030088

Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The Counter Use__

(Optional Format 1-2-96)