DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A

K100778 · Siemens Healthcare Diagnostics · JIX · May 5, 2010 · Clinical Chemistry

Device Facts

• Record ID: K100778
• Device Name: DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JIX · Clinical Chemistry
• Decision Date: May 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The LOCI Thyroid Calibrator is an in vitro diagnostic product for the calibration of the LOCI Free Triiodothyronine (FT3L), LOCI Free Thyroxine (FT4L) and LOCI Thyroid Stimulating hormone (TSHL) methods on the Dimension® EXL™ integrated chemistry system with LOCI® Module.

Device Story

LOCI Thyroid Calibrator is a multi-analyte, liquid, bovine serum albumin-based product containing triiodothyronine, thyroxine, and human thyroid stimulating hormone. Used in clinical laboratory settings to calibrate specific thyroid hormone assays (FT3, FT4, TSHL) on the Dimension EXL integrated chemistry system with LOCI module. The calibrator ensures the accuracy and reliability of patient test results by establishing a reference point for the instrument's measurement methods. It is intended for professional use by laboratory personnel.

Clinical Evidence

No clinical data. Bench testing only. Shelf-life and open-vial stability were demonstrated using real-time data from 3 lots. Value assignment traceability for FT4 and TSH was previously established in k073604 and k081103; FT3 traceability was established via anchor and master pool calibration.

Technological Characteristics

Multi-analyte, liquid, bovine serum albumin-based calibrator. Contains triiodothyronine, thyroxine, and human thyroid stimulating hormone. 5 levels. Storage 2–8 °C. Used on Dimension® EXL™ integrated chemistry system with LOCI® Module.

Indications for Use

Indicated for the calibration of LOCI Free Triiodothyronine (FT3), Free Thyroxine (FT4), and Thyroid Stimulating Hormone (TSHL) assays on the Dimension EXL integrated chemistry system. No specific patient population or contraindications described.

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

• Siemens LOCI® THYR Calibrator (k073604)

Submission Summary (Full Text)

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# 510k Summary

# LOCI Thyroid Calibrator

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.

- A. 510(k) Number: k100778
- B. Date of Preparation: May 3, 2010
- C. Proprietary and Established Names:

LOCI Thyroid Calibrator

#### D. Applicant:

Siemens Healthcare Diagnostics Inc.

P.O. Box 6101, Newark, DE 19714-6101

Rose T. Marinelli, Regulatory Technical Specialist

Office Number: [phone] fax Number: [phone]

#### E. Regulatory Information:

# LOCI THYR Calibrator:

- 1. Regulation section: 21 CFR § 862.1150 Calibrator
- 2. Classification: Class II
- 3. Product Code: JIX Calibrator, Secondary
- 4. Panel: Immunology
- F. Predicate Device:

The predicate device used to demonstrate substantial equivalence to the LOCI Thyroid Calibrator is the current LOCI Thyroid Calibrator cleared under k073604.

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# G. Device Description:

The LOCITHYR CAL is a multi-analyte, liquid, bovine serum albumin based product containing triiodothyronine, thyroxine and human thyroid stimulating hormone. The kit consists of ten vials with two vials per level containing 2.0 mL per vial.

## H. Intended Use:

The LOCI THYR CAL is an in vitro diagnostic product for the calibration of the LOCI Free Triiodothyronine (FT3), LOCI Free Thyroxine (FT4L) and LOCI Thyroid Stimulating Hormone (TSHL) methods on the Dimension® EXL™ integrated chemistry system with LOCI® Module.

## I. Substantial Equivalence Information:

The LOCI Thyroid Calibrator and the current Thyroid Calibrator as the predicate were compared. The following table provides a comparison of the important similarities and differences:

| Feature | LOCI THYR Calibrator<br>(RC610A) | LOCI THYR Calibrator<br>(RC610) (k073604) |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LOCI THYR CAL is<br>an in vitro diagnostic<br>product for the calibration<br>of the LOCI Free<br>Triiodothyronine (FT3),<br>LOCI Free Thyroxine<br>(FT4L) and LOCI Thyroid<br>Stimulating Hormone<br>(TSHL) methods on the<br>Dimension® EXLTM<br>integrated chemistry system<br>with LOCI® Module. | The LOCI THYR CAL is<br>an in vitro diagnostic<br>product for the calibration<br>of the LOCI Free<br>Thyroxine (FT4L) and<br>LOCI Thyroid Stimulating<br>Hormone (TSHL) methods<br>on the Dimension® EXLTM<br>integrated chemistry system<br>with LOCI® Module |
| Matrix | Bovine Serum Albumin | Bovine Serum Albumin |
| Levels | 5 Levels | 5 Levels |
| Preparation | Liquid | Liquid |
| Storage | 2 – 8 °C | 2 – 8 °C |

## J. Conclusion:

The LOCI THYR calibrator (RC610A) is substantially equivalent to the current LOCl Thyroid Calibrator cleared under k073604.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three distinct head-like shapes, suggesting a sense of movement or multiple perspectives. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Siemens Healthcare Diagnostics c/o Ms. Rose T. Marinelli Regulatory Technical Specialist PO BOX 6101 MS 514 Newark, DE 19714-6101

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring MD 20993

MAY 0 5 2010

Re: k100778

Trade Name: LOCI Thyroid Calibrator Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator -Regulatory Class: Class II Product Codes: JIX Dated: March 18, 2010 Received: March 19, 2010

Dear Ms. Marinelli:

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 concérning 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

Courtney C. Harper, 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 Form

510(k) Number (if known): K100778

Device Name:

LOCI Thyroid Calibrator

Indications for Use: The LOCI THYR CAL is an in vitro diagnostic product for the calibration of the LOCI Free Triiodothyronine (FT3), LOCI Free Thyroxine (FT4), and LOCI Thyroid Stimulating Hormone (TSHL) methods on the Dimension® EXL™ integrated chemistry system with LOCI® Module.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

Division Sign-Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K100778