DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)

K032697 · Dade Behring, Inc. · JIS · Nov 7, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032697
• Device Name: DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
• Applicant: Dade Behring, Inc.
• Product Code: JIS · Clinical Chemistry
• Decision Date: Nov 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The T3 Calibrator is intended for use in the calibration of Total Triiodothyronine (T3) method on the Dimension® clinical chemistry system with the Heterogeneous Immunoassay Module.

Device Story

The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is a liquid, multi-level calibrator kit consisting of 10 vials (two each at five levels). Level 1 contains stripped human serum; levels 2-5 contain L-triiodothyronine in a stripped human serum base. The device is used in a clinical laboratory setting to calibrate the T3 assay on the Dimension® clinical chemistry system equipped with a Heterogeneous Immunoassay Module. By establishing a calibration curve, the device enables the system to accurately quantify T3 concentrations in patient samples, supporting clinical diagnostic decision-making regarding thyroid function.

Clinical Evidence

bench testing only

Technological Characteristics

Liquid calibrator kit; 5 levels (0, 1, 2, 4, 6.5 ng/mL); matrix: stripped human serum base; analyte: L-triiodothyronine. Designed for use with Dimension® clinical chemistry system Heterogeneous Immunoassay Module.

Indications for Use

Indicated for use as a calibrator for the Total Triiodothyronine (T3) assay on the Dimension® clinical chemistry system with the Heterogeneous Immunoassay Module.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Opus Total T3 Calibrator (K953160)

Submission Summary (Full Text)

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K032697

# Summary of Safety and Effectiveness Information

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

| Submitter's Name: | Lorraine Piestrak<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|--------------------------|----------------------------------------------------------------------------------|
| Date of Preparation: | August 29, 2003 |
| Name of Product: | Dimension® Total Triiodothyronine (T3) Calibrator (RC414) |
| FDA Classification Name: | Calibrator |
| Predicate Device: | Opus Total T3 Calibrator (K953160) |

Device Description: The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is a liquid product. The kit consists of 10 vials, two each at levels 1 through 5. Level 1 vials contain 2 mL of stripped human serum. Vials for levels 2 through 5, contain 1 mL with concentrations of L-triiodothyronine in a stripped human serum base.

Intended use: The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is intended for use in the calibration of the Total Triiodothyronine (T3) method on the Dimension® clinical chemistry system with the Heterogeneous Immunoassay Module.

# Comparison to Predicate Device:

| | Dimension®<br>T3 Calibrator | Opus<br>Total T3 Calibrator |
|--------------|-------------------------------------------------------|-------------------------------------------------------|
| Intended Use | Calibrator | Calibrator |
| Analyte | T3 | T3 |
| Matrix | stripped human serum base | stripped human serum base |
| Form | liquid | liquid |
| Volume | 2 mL per vial @ level 1<br>1 mL per vial @ levels 2-5 | 2 mL per vial @ level 1<br>1 mL per vial @ levels 2-6 |
| Levels | 5 levels<br>@ 0, 1, 2, 4, 6.5 ng/ml | 6 levels<br>@ 0, 0.5, 1, 2, 4, 6 ng/ml |

Comments on Substantial Equivalence: Both the proposed Dade Behring Dimension® Total Triiodothyronine (T3) Calibrator (RC414) and the existing Opus Total T3 calibrator are in vitro diagnostic products intended for calibrating T3 assays.

Conclusion: The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is substantially equivalent to the Opus Total T3 Calibrators based on the comparison discussed above.

Lorraine Piestrak

Fraine Piestrak Regulatory Affairs and Compliance Manager August 29, 2003

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle image.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Larraine Piestrak Regulatory Affairs and Compliance Manager Dade Behring, Inc. Chemistry/Immunochemistry Glasgow Business Community P.O. Box 6101 - Building 500 Newark, Delaware 19714

NOV - 7 2003

Re: k032697

Trade/Device Name: Dimension® Total Triiodothyronine Calibrator (RC414) Regulation Number: 21 CFR § 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIS Dated: August 29, 2003 Received: September 2, 2003

Dear Ms. Piestrak:

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/dsma/dsmamain.html.

Sincerely yours,

iteven 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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#### Indications For Use Statement

Device Name: Dimension® Total Triiodothyronine Calibrator (RC414)

# Indications for Use:

The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is intended for use in the calibration of the Total Triiodothyronine (T3) method on the Dimension® clinical chemistry system with the Heterogeneous Immunoassay Module.

Lorraine Piestrak

Regulatory Affairs and Compliance Manager

August 29, 2003

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-the-counter Use

Carol Benson / Jean Cooper, DVM
Division Sign-Off

\$10(k) k032697

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