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.

Device Description

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.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Siemens Healthcare Diagnostics Inc. Dimension® TSHL Flex® reagent cartridge and TSH Sample Diluent:

Acceptance Criteria and Device Performance

The submission focuses on demonstrating substantial equivalence to a predicate device, the Dimension Vista™ TSH Flex® reagent cartridge. The primary acceptance criterion for the new device, the Dimension® TSHL Flex® reagent cartridge, is to show excellent correlation with the predicate device.

Acceptance Criteria	Reported Device Performance (Dimension® TSHL Flex® vs. Dimension® Vista TSH Flex®)
Correlation Coefficient (r)	0.997
Slope	1.05
95% CI (for Slope)	1.0442 to 1.0649
y-intercept	-0.04 µIU/mL
Sy,x (Standard Error)	1.708 µIU/mL
Assay Range	0.007-100 µIU/mL (Predicate: 0.005-100 µIU/mL)
Intended Use	Quantitative measurement of TSH in human serum and plasma
Sample Type	Human serum and plasma
Technology	LOCI® technology
Sample Size	12 µL
Reagents and Antibody	Same as predicate
Uses TSH Sample Diluent	Yes

Study Information

Sample size used for the test set and the data provenance:
- Sample Size: Two hundred and ten (210) serum samples.
- Data Provenance: Not explicitly stated, but typically these samples would be clinical samples representing various TSH levels. The document does not specify country of origin or if they were retrospectively or prospectively collected.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This study is a method comparison study against a predicate device, not a diagnostic accuracy study requiring expert-established ground truth for individual cases. The "ground truth" for the new device's performance is its correlation with the established predicate device's measurements.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is a quantitative laboratory measurement comparison, not a qualitative assessment requiring adjudication of results from multiple readers.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This is not an AI-assisted diagnostic device, but rather an in vitro diagnostic reagent cartridge assessing TSH levels.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The study evaluates the performance of the TSHL Flex® reagent cartridge as a standalone measurement tool on the Dimension® EXL™ with LM system, comparing its quantitative results directly against the quantitative results of the predicate device (Dimension Vista™ TSH Flex® reagent cartridge). There is no "human-in-the-loop" component being evaluated in this specific comparison beyond the standard operation of the laboratory instruments.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" in this context is the quantitative measurement provided by the legally marketed predicate device, the Dimension Vista™ TSH Flex® reagent cartridge. The intent is to show that the new device produces results that are statistically comparable and correlate strongly with the predicate device.
The sample size for the training set:
- Not applicable. This is a method comparison study for an in vitro diagnostic assay, not a machine learning or AI model that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device and study.

Summary

{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: 302-631-7626

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 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®reagent cartridge	Dimension® TSHL Flex®reagent cartridge
Intended Use	Both devices are for in vitro diagnostic use for the quantitativemeasurement of Thyroid Stimulating Hormone in human serumand plasma.
Sample Type	Acceptable sample types are human serum and plasma.
Assay Range	The Dimension Vista® TSHmethod has an assay range of0.005-100 µIU/mL.	The Dimension® TSHL methodhas an assay range of 0.007-100µIU/mL.
Technology	Both devices use LOCI® technology.
Sample Size	Both devices use a sample volume of 12 µL.
Reagents andantibody	Both devices use the same liquid reagents and antibody.
Diluent	Both devices use the TSH Sample Diluent to manually dilute highsamples.
Instrument	The Dimension Vista® TSHFlex® is run on the DimensionVista® analyzer.	The Dimension® TSHL Flex®is run on the Dimension®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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 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

Regulation Number and Section

§ 862.1690 Thyroid stimulating hormone test system.

(a)
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.(b)
Classification. Class II.