LOCI THYROID CALIBRATOR WITH MODEL RC610

K081103 · Siemens Healthcare Diagnostics, Inc. · JIX · May 23, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081103
• Device Name: LOCI THYROID CALIBRATOR WITH MODEL RC610
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: May 23, 2008
• 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 FT4L and TSHL methods on the Dimension® EXL™ with LM system.

Device Story

LOCI Thyroid Calibrator is a liquid, bovine serum albumin-based product containing human thyroid stimulating hormone (TSH) and thyroxine (T4). Used in clinical laboratory settings to calibrate FT4L and TSHL assays on the Dimension® EXL™ with LM system. Calibrator levels 2-6 are utilized to establish assay curves, ensuring accurate measurement of thyroid analytes in patient samples. Healthcare providers use the resulting assay outputs to assess thyroid function and guide clinical management. Benefits include standardized, accurate diagnostic testing for thyroid-related conditions.

Clinical Evidence

No clinical data. Stability established through real-time testing on 3 lots of product at multiple time points against pre-defined acceptance criteria.

Technological Characteristics

Liquid, bovine serum albumin-based matrix. Contains human TSH and FT4. Five-level calibrator set. Traceable to internal master pools (FT4) and WHO TSH 2nd IRP 80/558 (TSH). Storage: 2-8°C. Intended for use with Dimension® EXL™ with LM system.

Indications for Use

Indicated for the calibration of FT4L and TSHL diagnostic methods on the Dimension® EXL™ with LM system. For prescription use.

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 Thyroid Calibrator (k073604)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness LOCI Thyroid Calibrator

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

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

### 1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation

Siemens Healthcare Diagnostics Inc. Manufacturer: P.O. Box 6101 Newark, DE 19714

Contact Information: Siemens Healthcarc Diagnostics Inc. P.O. Box 6101 Newark, DE 19714 Attn: Yuk-Ting Lewis Tel: [phone]

Date of Preparation: April 14, 2008

#### 2. Devicc Name / Classification

LOC1 Thyroid Calibrator / 21 CFR 862.1150 / Class 11

#### Identification of the Predicate Device 3.

LOCI Thyroid Calibrator, K073604

#### 4. Device Description

The LOCI Thyroid Calibrator is a liquid, bovine serum albumin based product containing thyroid stimulating hormone and thyroxine. The calibrator levels and their assigned values are:

| | evel | .<br>Level 3 | LA MARKE<br>Level | Level | Level |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|--------------|-----------------------------------------------------------------------------------------------------------------|------------|---------------|
| 135 11<br>The Property of the Production of the Property of the Production of the Production of the Production of the Production of the Property of Property of Property of Property of | | ng | no<br>C<br>- 24 ----<br>A minimum a come of the a fine of the of the of the of the one of the one of the county | ng | no/<br>i<br>- |
| . TEU' | | .<br>1877 | 4,555 | ﺎ ﮐﺎ<br>00 | -------- |

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#### ട്. Device Intended Use

The LOCI Thyroid Calibrator is an in vitro diagnostic product for the calibration of the FT4L and TSHL methods on the Dimension® EXL™ with LM system.

#### .b Medical device to which equivalence is claimed and comparison information

The LOCI Thyroid Calibrator is substantially equivalent to the calibrator previously cleared under K073604. The LOCl Thyroid Calibrator contains human thyroid stimulating hormone and thyroxinc for calibrating the Dimension® TSHL and FT4L methods.

| Feature | Predicate Device:<br>LOCI Thyroid Calibrator | New Device:<br>LOCI Thyroid Calibrator |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LOCI Thyroid Calibrator is<br>used to calibrate the<br>Dimension® FT4L method on<br>the Dimension® EXL™ with<br>LM system. | The LOCI Thyroid Calibrator is<br>used to calibrate the<br>Dimension® FT4L and TSHL<br>methods on the Dimension®<br>EXLT™ with LM system. |
| Analyte and Matrix | The LOCI Thyroid Calibrator<br>contains thyroxine in a bovine<br>serum albumin matrix. | The LOCI Thyroid Calibrator<br>contains human thyroid<br>stimulating hormone and<br>thyroxine in a bovine serum<br>albumin matrix. |
| Form | The calibrators are in liquid form. | |
| Calibrator levels | The LOCI Thyroid Calibrator<br>kit contains Levels 3 through 6. | The LOCI Thyroid Calibrator<br>kit contains Levels 2 through 6.<br>Levels 3 through 6 are used to<br>calibrate the FT4L method.<br>Levels 2 through 6 are used to<br>calibrate the TSHL method. |
| Stability | The stability of the calibrators is established through real-time data<br>on 3 lots of product. Testing is conducted at multiple time points<br>and must pass pre-defined acceptance criteria. | |
| Traceability | The calibrator is traceable to an<br>internal master pool for FT4. | The calibrator is traceable to an<br>internal master pool for FT4 and<br>to the WHO standard for TSH. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 3 2008

Siemens Healthcare Diagnostics, Inc. c/o Yuk-Ting Lewis P.O. Box 6101, M/S 514 Newark, DE 19714

Re: k081103 Trade/Device Name: LOCI Thyroid Calibrator Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: May 13, 2008 Received: May 14, 2008

Dear Ms. Lewis:

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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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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Jéan M. Cooper, M.S., D.V.M. 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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# Indication for Use

510(k) Number (if known): < 08 | | 0 3

Device Name: LOCI Thyroid Calibrator

Indications For Use:

The LOCI Thyroid Calibrator is an in vitro diagnostic product for the calibration of the FT4L and TSHL methods on the Dimension® EXL™ with LM system.

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Benson

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

510(k) K081103