DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691

K081074 · Siemens Healthcare Diagnostics, Inc. · JLW · May 23, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081074
• Device Name: DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JLW · Clinical Chemistry
• Decision Date: May 23, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Intended Use

The TSHL method is an in vitro diagnostic test intended for the quantitative measurement of Thyroid Stimulating Hormone (TSH, thyrotropin) in human serum and plasma on the Dimension® EXLTM with LM system. Measurements of TSH are used in the diagnosis and monitoring of thyroid disease. The TSH Sample Diluent is an in vitro diagnostic product for manual dilution of samples with elevated TSH results processed on the Dimension Vista® and Dimension® EXL™ with LM Systems.

Device Story

Dimension® TSHL Flex® reagent cartridge is an in vitro diagnostic device for quantitative TSH measurement in human serum/plasma. Used on Dimension® EXL™ with LM system. Employs LOCI® technology; utilizes liquid reagents and antibodies identical to predicate. TSH Sample Diluent (bovine serum albumin-based) allows manual dilution of high-concentration samples. Operated by laboratory personnel in clinical settings. Output provides TSH concentration values to clinicians for thyroid disease diagnosis and monitoring. Benefits include accurate, automated TSH quantification for clinical decision-making.

Clinical Evidence

Bench testing only. Precision and method comparison studies performed against automated laboratory analyzer. Results demonstrated that predetermined acceptance criteria were met.

Technological Characteristics

In vitro diagnostic reagent cartridge; LOCI® (Luminescent Oxygen Channeling Immunoassay) technology; bovine serum albumin-based diluent; 12 µL sample volume; liquid reagents; compatible with Dimension® EXL™ with LM system.

Indications for Use

Indicated for use as an in vitro diagnostic reagent for the quantitative determination of TSH in human serum and plasma on the Dimension Vista system.

Regulatory Classification

Identification

A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

Predicate Devices

• Dimension Vista™ TSH Flex® reagent cartridge (K060090)

Submission Summary (Full Text)

{0}------------------------------------------------

# MAY 2 3 2008

## 510(k) Summary of Safety and Effectiveness Dimension® TSHL Flex® reagent cartridge and TSH Sample Diluent

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: < < 0810 74

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

Manufacturer:

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

Contact Information:

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

Date of Preparation:

May 5, 2008

#### Device Name / Classification 2.

Dimension® TSHL Flex® reagent cartridge / Class II TSH Sample Diluent / Class II

#### Identification of the Predicate Device 3.

Dimension Vista™ TSH Flex® reagent cartridge, K060090

#### Device Description 4.

The Dimension® TSHL Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight-well cartridge for use on the Dimension® EXL™ with LM system.

The TSH Sample Diluent is a liquid, bovine serum albumin based product with preservatives.

Page 1 of 3

{1}------------------------------------------------

#### ਪੰ Device Intended Use

The TSHL method is an in vitro diagnostic test intended for the quantitative measurement of Thyroid Stimulating Hormone (TSH, thyrotropin) in human serum and plasma on the Dimension® EXLTM with LM system. Measurements of TSH are used in the diagnosis and monitoring of thyroid disease.

The TSH Sample Diluent is an in vitro diagnostic product for manual dilution of samples with elevated TSH results processed on the Dimension Vista® and Dimension® EXL™ with LM Systems.

#### Medical device to which equivalence is claimed and comparison information 6.

The Dimension® TSHL Flex® reagent cartridge is substantially equivalent in intended use and technological characteristics to the Dimension® Vista TSH Flex® reagent cartridge. A comparison of features is provided.

| Feature | Predicate Device: | New Device: |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| | Dimension Vista® TSH Flex®<br>reagent cartridge | Dimension® TSHL Flex®<br>reagent cartridge |
| Intended Use | Both devices are for in vitro diagnostic use for the quantitative<br>measurement of Thyroid Stimulating Hormone in human serum<br>and plasma. | |
| Sample Type | Acceptable sample types are human serum and plasma. | |
| Assay Range | The Dimension Vista® TSH<br>method has an assay range of<br>0.005-100 µIU/mL. | The Dimension® TSHL method<br>has an assay range of 0.007-100<br>µIU/mL. |
| Technology | Both devices use LOCI® technology. | |
| Sample Size | Both devices use a sample volume of 12 µL. | |
| Reagents and<br>antibody | Both devices use the same liquid reagents and antibody. | |
| Diluent | Both devices use the TSH Sample Diluent to manually dilute high<br>samples. | |
| Instrument | The Dimension Vista® TSH<br>Flex® is run on the Dimension<br>Vista® analyzer. | The Dimension® TSHL Flex®<br>is run on the Dimension®<br>EXLTM with LM system. |

{2}------------------------------------------------

## Comparison Information

Method comparison studies were conducted on the Dimension® TSHL Flex® vs. the Dimension® Vista TSH Flex® reagent cartridge using two bundred-and-ten (210) serum samples. The data was analyzed using least squares linear regression. The Dimension® TSHL Flex® demonstrated excellent correlation to the predicate device as evidenced by a correlation coefficient = 0.997. The resulting regression statistics are shown below.

| Slope | 1.05 |
|--------|------------------|
| 95% CI | 1.0442 to 1.0649 |
| y-int | -0.04 µIU/mL |
| r | 0.997 |
| Sy,x | 1.708 µIU/mL |

er i

: : : :

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, and it is often used to represent the Department of Health & Human Services.

Public Health Service

Image /page/3/Picture/3 description: The image shows a date stamp with the month, day, and year. The month is JUL, the day is 91, and the year is 2008. The text is in bold and black.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k081074 Trade/Device Name: Dimension TSHL Flex reagent cartridge and TSH sample diluents with models rf 612 and kd691 Regulation Number: 21 CFR §862.1690 Regulation Name: Thyroid Stimulating Hormone test system. Regulatory Class: Class II Product Code: JLW Dated: May 13, 2008 Received: May 14, 2008

Dear Ms. Lewis:

This letter corrects our substantially equivalent letter of May 23, 2008.

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. Isting 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 100-1050.

{4}------------------------------------------------

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

Sincerely vours.

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

Yean 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

{5}------------------------------------------------

# Indication for Use

510(k) Number (if known): k 081074

Device Name: Dimension® TSHL Flex® reagent cartridge TSH Sample Diluent

Indications For Use:

## Method

The TSHL method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone (TSH, thyrotropin) in human serum and plasma on the Dimension® EXLTM with LM System. Measurements of TSH are used in the diagnosis and monitoring of thyroid disease.

## Diluent

The TSH Sample Diluent is an in vitro diagnostic product for manual dilution of samples with elevated TSH results processed on the Dimension Vista® and Dimension® EXL™ with LM systems.

Prescription Use × (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 Benson
Division Sign Off

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

510(k) K081074

Page 1 of 1