DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250

K061885 · Dade Behring, Inc. · JIT · Aug 14, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061885
• Device Name: DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250
• Applicant: Dade Behring, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Aug 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The T3 CAL is an in vitro diagnostic product for the calibration of Total Triiodothyronine (T3) method on the Dimension Vista™ System. For prescription use

Device Story

T3 CAL is a liquid, human serum-based calibrator containing L-triiodothyronine; used to calibrate Total Triiodothyronine (T3) assays on the Dimension Vista™ System. Kit includes six vials (three of Calibrator A, three of Calibrator B). Product is ready-to-use; no preparation required. Human source materials tested negative for HIV-1/2, HbsAg, and HCV. Used by laboratory professionals to ensure accuracy of T3 measurements, which support clinical assessment of thyroid function.

Clinical Evidence

No clinical data. Bench testing only. Traceability established via USP L-triiodothyronine. Stability protocols and acceptance criteria were reviewed and found acceptable.

Technological Characteristics

Liquid, stripped human serum-based calibrator. Two-level configuration. Traceable to USP L-triiodothyronine (Catalog #36800). Designed for use with Dimension Vista™ System. Complies with CEN 13640 (stability) and ISO 14971:2000 (risk management).

Indications for Use

Indicated for the calibration of Total Triiodothyronine (T3) methods on the Dimension Vista™ System in clinical laboratory settings.

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

• Dimension® Total Triiodothyronine Calibrator (k032697)

Submission Summary (Full Text)

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# 510(k) Summary for the Dimension Vista™ System Total Triiodothyronine Calibrator (T3 CAL - KC250)

| <b>A. 510(k) Number:</b> | K061885 AUG 1 4 200 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>B. Analyte:</b> | Total Triiodothyronine (T3) |
| <b>C. Type of Test:</b> | Calibrator Material |
| <b>D. Applicant:</b> | Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101<br>Victor M. Carrio, Regulatory Affairs and Compliance Manager<br>Office: [phone] Fax: [phone] |

## E. Proprietary and Established Names:

Dimension Vista™ System Total Triiodothyronine Calibrator (T3 CAL - KC250)

### F. Regulatory Information:

- 1. Regulation section: 21 CFR § 862-1150 Calibrator
- 2. Classification: Class II
- 3. Product Code: JIT Calibrator, Secondary
- 4. Panel: Clinical Chemistry
- G. Intended Use: The T3 CAL is an in vitro diagnostic product for the calibration of Total Triiodothyronine (T3) method on the Dimension Vista " System.

# H. Device Description:

The T3 CAL is a liquid, human serum based product containing Ltriiodothyronine. The kit consists of six vials, three vials of Calibrator A (2.0 mL per vial) and three vials of Calibrator B (1.5 mL per vial). T3 CAL is ready for use, no preparation is required.

### I. Substantial Equivalence Information:

- 1. Predicate Device: K032697 Dimension® Total Triiodothyronine Calibrator.
- 2. Comparison with Predicate:

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| | Device | Predicate |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Dimension Vista™<br>System Total<br>Triiodothyronine<br>Calibrator | Dimension®<br>Total Triiodothyronine<br>Calibrator |
| Intended Use | The T3 CAL is an in vitro<br>diagnostic product for the<br>calibration of Total<br>Triiodothyronine (T3) method<br>on the Dimension Vista™<br>System. | The T3 Calibrator is intended for use<br>in the calibration of Total<br>Triiodothyronine (T3) method on the<br>Dimension® clinical chemistry<br>system with the Heterogeneous<br>Immunoassay Module. |
| Analytes | Total Triiodothyronine (T3). | Total Triiodothyronine (T3). |
| Form | Liquid | Liquid |
| Traceability | USP¹ L-triiodothyronine<br>(USP Catalog # 36800) | USP¹ L-triiodothyronine<br>(USP Catalog # 36800) |
| Matrix | Stripped human serum.base. | Stripped human serum.base. |
| Levels | Two levels. | Five levels. |

1 United States Pharmacopeia

## J. Standard/Guidance Document Referenced:

| 1. Guidance: | Guidance for Industry - Abbreviated 510(k) Submissions for In<br>Vitro Diagnostic Calibrators; Final, 02/22/1999<br>Guidance for Industry and FDA Staff - Use of Symbols on Labels<br>and in Labeling of In Vitro Diagnostic Devices Intended for<br>Professional Use, 11/30/2004 |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

- 2. Standards: CEN 13640 Stability testing of In-Vitro Diagnostic Devices ISO 14971:2000 Medical devices -Application of risk management to medical devices
### K. Performance Characteristics:

Target shelf life for the Dimension Vista™ System Total 1. Stability: Triiodothyronine (T3) Calibrator is 24 months. Calibrator shelf life is determined by comparing results of the product stored at 4℃ with control stored at -20°C. The method is calibrated from this stored material. The 4°C material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined. Percent change should be less than or equal to 8 %. Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc.

A vial punctured by the instrument and stored on board is stable for one day.

An open vial not stored on board of the instrument, but recapped and stored in a refrigerator is stable for 31 days.

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For testing, vials are opened /punctured on day zero. For opened viales, a quantity sufficient for multiple calibrations is removed and the vials are recapped and stored at 2 - 8 °C. Opened vials are tested on days 0, 2, 8, 15, 22, and 32 versus freshly opened vials. Punctured vials are tested once after at least 25 hours versus freshly opened vials.

- 2. Traceability: The assigned values of the Total Triiodothyronine (T3) Calibrator are traceable to the United Stated Pharmacopeia (USP) Ltriiodothyronine (USP Catalog # 36800).
- 3. Value Assignment:

Master Pool is manufactured by weighing USP L-triiodothyronine (USP Catalog # 36800) into stripped human serum at five levels. The Master Pool is stored frozen, -10 to -20 °C. The bottle value for the Master Pool is assigned for each level by testing N = 45 replicates per level on multiple instruments, using a previous Master Pool as a control.

A Commercial Lot is manufactured by weighing Purified T3 into stripped human serum at two levels. The bottle value assignment of each level is tested using multiple instruments calibrated with Master Pool for N = 45 total replicates per level. A previous lot of commercial calibrator is used as control.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized wings or feathers.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

### AUG 1 4 2006

Mr. Victor M. Carrio RA/QS Compliance Manager Dade Behring, Inc. PO Box 6101 Newark, DE 19714-6101

Re: k061885

> Trade/Device Name: Dimension VistaTM Total Triiodothyronine Calibrator (T3 CAL, KC250) Regulation Number: 21 CFR§862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: June 30, 2006 Received: July 3, 2006

Dear Mr. Carrio:

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). 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,

Alberto Guts

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications For Use Statement

510(k) Number (if known): -

**Device Name:** K061885

Dimension Vista™ Total Triiodothyronine Calibrator (T3 CAL , KC250) .

Indications for Use:

The T3 CAL is an in vitro diagnostic product for the calibration of Total Triiodothyronine (T3) method on the Dimension Vista" System.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-the-counter Use (21 CFR 801 Subpart C)

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

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