The FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® Module. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease.
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® EXL™ integrated chemistry system with LOCI® Module. Measurements of TSH are used in the diagnosis and monitoring of thyroid disease.

Device Description

The Dimension® LOCI Free Thyroxine Flex® reagent cartridge, FT4L and Dimension® LOCI Thyroid Stimulating Hormone Flex® reagent cartridge, TSHL are in vitro diagnostic tests for the quantitative measurement of Free Thyroxine and Thyroid Stimulating Hormone, respectively, in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® Module. The submission is for the inclusion of pediatric reference intervals to the labeling (Package Inserts) of these assays. No changes were made to the reagents, device design, or manufacturing process.

AI/ML Overview

The provided document is a 510(k) summary for the Siemens Healthcare Diagnostics Dimension® LOCI Free Thyroxine Flex® Reagent Cartridge (FT4L) and Dimension® LOCI Thyroid Stimulating Hormone Flex® Reagent Cartridge (TSHL). The focus of this submission is the addition of pediatric reference intervals to the existing devices, not a primary submission for a new device. Therefore, the information provided primarily pertains to the establishment of these pediatric reference intervals.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the pediatric reference intervals are defined by the statistical methods used to establish them and the resulting intervals. The performance reported is the calculated pediatric reference intervals.

Acceptance Criteria	Reported Device Performance (FT4L)	Reported Device Performance (TSHL)
Infant (01-23 months): Reference interval established using robust symmetrical method due to sample size < 120, validated against simulated non-parametric and robust symmetric intervals.	Reference Interval: 0.93 - 1.45 ng/dL	Reference Interval: 0.867 – 6.43 µIU/mL (Established using robust symmetrical method after log transformation due to skewed data)
Children (02-12 years): Reference interval established using non-parametric approach (2.5th and 97.5th percentiles).	Reference Interval: 0.82 - 1.40 ng/dL	Reference Interval: 0.704 - 4.01 µIU/mL
Adolescents (13-20 years): Reference interval established using non-parametric approach (2.5th and 97.5th percentiles).	Reference Interval: 0.78 - 1.34 ng/dL	Reference Interval: 0.516 - 4.13 µIU/mL
Confidence Intervals for Infant 95% Reference Intervals: 90% confidence intervals for lower and upper limits.	90% CI of Lower Limit: 0.89 - 0.97 ng/dL 90% CI of Upper Limit: 1.41 - 1.50 ng/dL	90% CI of Lower Limit: 0.710 - 1.04 µIU/mL 90% CI of Upper Limit: 5.40 - 7.54 µIU/mL

2. Sample Size Used for the Test Set and the Data Provenance

The "test set" in this context refers to the patient samples used to establish the pediatric reference intervals.

FT4L Assays: Data from a total of 411 patients
- Infants (01 – 23 months): 77 patients
- Children (02 – 12 years): 187 patients
- Adolescents (13 – 20 years): 147 patients
TSHL Assays: Data from a total of 407 patients
- Infants (01 – 23 months): 75 patients
- Children (02 – 12 years): 185 patients
- Adolescents (13 – 20 years): 147 patients

Data Provenance: The document does not specify the country of origin. It also doesn't explicitly state whether the data was retrospective or prospective, but the phrasing "Data ... were analyzed to establish the reference intervals" suggests it was likely retrospective analysis of collected samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The ground truth here is the definition of "healthy" individuals within the pediatric age groups to establish reference intervals. The document does not mention the use of experts to establish individual ground truths for each sample in the test set. Instead, it refers to a population used to establish the reference intervals. The underlying assumption is that these patients were deemed healthy for their age group. The statistical methods (CLSI C28-A3c, CLSI EP28-A3) mentioned are standard guidelines for establishing reference intervals in clinical laboratories, which are developed and endorsed by experts in the field of clinical pathology and laboratory medicine, but individual experts are not described as adjudicating each case.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned for the test set. The process involves collecting samples presumably from healthy individuals within the pediatric age groups and applying statistical methods guided by CLSI standards to determine the reference intervals.

5. 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

This section is not applicable. The device (reagent cartridge) is an in vitro diagnostic test for quantitative measurement of hormones, not an imaging device or an AI-driven tool requiring human reader interpretation in the manner of an MRMC study. The study focuses on establishing reference intervals for a laboratory test.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. The device is a laboratory reagent. The "performance" being evaluated here is the ability to accurately define reference intervals for existing assays, which is a statistical and clinical validation task, not an algorithm's standalone performance in the typical sense of AI. The assay itself works in a standalone (automated) manner on the Dimension® EXL™ system with LOCI® Module. The current submission's scope is the labeling modification to add pediatric reference intervals.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for establishing pediatric reference intervals is based on healthy pediatric populations. The individuals included in the study for establishing reference intervals are assumed to be "healthy" (euthyroid, meaning normal thyroid function) for their age group. This is a common method for establishing reference ranges in laboratory medicine, following guidelines like CLSI C28-A3c. It's not individual expert consensus on specific cases, pathology reports, or long-term outcomes data, but rather a statistical representation of a healthy population.

8. The Sample Size for the Training Set

This submission is about establishing reference intervals, which traditionally does not involve a "training set" in the machine learning sense. The patient data described in point 2 is used directly to establish the reference intervals, rather than training an algorithm.

9. How the Ground Truth for the Training Set Was Established

As explained above, there isn't a "training set" in the typical AI/ML context. The patient samples used to establish the reference intervals are assumed to be from "healthy" individuals in the respective pediatric age groups, following standard clinical laboratory guidelines for reference interval studies.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 26, 2014

SIEMENS HEALTHCARE DIAGNOSTICS INC. FRANCES DILLON SR. MANAGER, REGULATORY AFFAIRS PO BOX 6101, M/S 514 NEWARK DE 19714-6101

Re: K140842

Trade/Device Name: Dimension® LOCI Free Thyroxine Flex® Reagent Cartridge, FT4L: Dimension® LOCI Thyroid Stimulating Hormone Flex® Reagent Cartridge. TSHL Regulation Number: 21 CFR 862.1695 Regulation Name: Free thyroxine test system Regulatory Class: II Product Code: CEC. JLW Dated: November 21, 2014 Received: November 24, 2014

Dear Frances Dillon:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K140842

Device Name

Dimension® LOCI Free Thyroxine Flex® reagent cartridge, FT4L

Indications for Use (Describe)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

Type of Use (Select one or both, as applicable)

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140842

Device Name

Dimension® LOCI Thyroid Stimulating Hormone Flex® reagent cartridge. TSHL

Indications for Use (Describe)

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® EXL™ integrated chemistry system with LOCI® Module. Measurements of TSH are used in the diagnosis and monitoring of thyroid disease.


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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Type of Use (Select one or both, as applicable)

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SIEMENS

Section 6. 510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92 and the Safe Medical Device Act of 1990.

The assigned 510(k) Number is: K140842

1. Date Prepared

November 25, 2014

2. Applicant Information

Contact:	Frances A. DillonSenior Manager, Regulatory Affairs
Address:	Siemens Healthcare Diagnostics Inc.P.O. Box 6101, M/S 514Newark, DE 19714
Phone:	302-631-6951
Fax:	302-631-6299
Email:	frances.a.dillon@siemens.com

Regulatory Information 3.

Table 1. Regulatory Information for Dimension® FT4L and TSHL Assays

	FT4L	TSHL
Trade Name	Dimension® LOCI Free ThyroxineFlex® reagent cartridge, FT4L	Dimension® LOCI Thyroid StimulatingHormone Flex® reagent cartridge,TSHL
Model Numbers	RF610	RF612
Common Name	Radioimmunoassay,free thyroxine	Radioimmunoassay, thyroid stimulatinghormone
Classification Name	Free thyroxine test system	Thyroid stimulating hormone testsystem
FDA Classification	Class II	Class II
Review Panel	Clinical Chemistry	Clinical Chemistry
Product Code	CEC	JLW
Regulation Number	862.1695	862.1690

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Predicate Device Information 4.

The inclusion of pediatric reference intervals to the labeling (Package Inserts) of the Dimension® FT4L and TSHL assays does not require any other device modifications (i.e. no change to design or manufacturing process). No changes were made to the reagents. Therefore, as shown in the table below, the predicate and subject devices are the same.

	FT4L	TSHL
Predicate Device	Dimension® LOCI Free ThyroxineFlex® reagent cartridge, FT4L	Dimension® LOCI Thyroid StimulatingHormone Flex® reagent cartridge,TSHL
Subject Device	Same (As above)	Same (As above)
Predicate 510(k)	K130276	K081074

		Table 2. Summary of Predicate Devices for Dimension® FT4L and TSHL Assays
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Substantial Equivalence Information 5.

The following table demonstrates substantial equivalence between the predicate Dimension® thyroid assays (with unmodified labeling) and Dimension® thyroid assays which have modified Instructions for Use (Package Inserts) including pediatric reference intervals.

Item	Predicate Device(Unmodified Labeling)	Subject Device(With Pediatric Reference Intervals)
Analytes	Dimension® FT4L	Dimension® FT4L
	Free Thyroxine (FT4)	Same
	Dimension® TSHL	Dimension® TSHL
	Thyroid Stimulating Hormone	Same
Reagents	Dimension® FT4L	Dimension® FT4L
	Dimension® LOCI Free ThyroxineFlex® reagent cartridge, FT4L	Same
	Dimension® TSHL	Dimension® TSHL
	Dimension® LOCI Thyroid StimulatingHormone Flex® reagent cartridge,TSHL	Same
Instruments	Dimension® EXL™ with LOCI®Module and Dimension® EXL™ 200	Same
Intended UseStatements	Dimension® FT4LThe FT4L method is an in vitrodiagnostic test for the quantitativemeasurement of Free Thyroxine inhuman serum and plasma on theDimension® EXL™ integratedchemistry system with LOCI® Module.Measurements of free thyroxine areused in the diagnosis and monitoring of	Dimension ® FT4LSame

Table 3. Summary of Substantial Equivalence for Dimension® FT4L and TSHL Assays

Item	Predicate Device(Unmodified Labeling)	Subject Device(With Pediatric Reference Intervals)
	thyroid disease.
	Dimension® TSHL	Dimension® TSHL
	The TSHL method is an in vitrodiagnostic test for the quantitativemeasurement of Thyroid StimulatingHormone (TSH, thyrotropin) in humanserum and plasma on the Dimension®EXL™ integrated chemistry systemwith LOCI® Module. Measurements ofTSH are used in the diagnosis andmonitoring of thyroid disease.	same
AnalyticalMeasuring Range(Assay Range)	Dimension® FT4L0.1 – 8.0 ng/dL [1.3 – 103 pmol/L]	Dimension® FT4LSame
	Dimension® TSHL	Dimension® TSHL
	0.007 – 100 μIU/mL [mIU/L]	Same
AdultReference Intervals	Dimension® FT4L0.76 – 1.46 ng/dL [9.8 – 18.8 pmol/L]The reference interval was transferredfrom that previously determined for theFT4 method on the Dimension Vista®System. It represents the central 95%of results determined non-parametrically from a population of 199healthy adults (140 males and 59females, 18 - 59 years of age). Theoriginal determination and transferenceto the FT4L method was done inaccordance with CLSI/NCCLS C28-A2.	Same
	Dimension® TSHL0.358 - 3.74 µIU/mL [mIU/L]The reference interval was transferredfrom that previously determined for theTSH method on the Dimension Vista®System. It represents the central 95%of results determined non-parametrically from a population of 297apparently healthy adults (187 malesand 110 females, 18 - 65 years ofage). The original determination andtransference to the TSHL method wasdone in accordance with CLSI/NCCLSC28-A2.	Same
Item	Predicate Device(Unmodified Labeling)	Subject Device(With Pediatric Reference Intervals)
PediatricReference Intervals	Dimension® FT4LNone	Dimension® FT4LInfants (01 – 23 months)0.93 - 1.45 ng/dLChildren (02 – 12 years)0.82 - 1.40 ng/dLAdolescents (13 – 20 years)0.78 - 1.34 ng/dL
	Dimension® TSHL	Dimension® TSHLInfants (01 – 23 months)0.867 – 6.43 µIU/mLChildren (02 – 12 years)0.704 - 4.01 µIU/mLAdolescents (13 – 20 years)0.516 - 4.13 µIU/mL

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Table 3. Summary of Substantial Equivalence for Dimension® FT4L and TSHL Assays

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Table 3. Summary of Substantial Equivalence for Dimension® FT4L and TSHL Assays

Standard/Guidance Document Reference 6.

Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline -- Third Edition (CLSI C28-A3c).

7. Pediatric Reference Intervals

Data from a total of 411 patients (77 infants, 187 children, 147 adolescents) were analyzed to establish the Dimension® FT4L assay reference intervals for the studied pediatric population. Data from a total of 407 patients (75 infants, 185 children, 147 adolescents) were analyzed to establish the Dimension® TSHL assay reference intervals for the studied pediatric population. Testing was performed on a Dimension® EXL™ with LM system. These pediatric reference intervals, as well as the previously-established euthyroid adult reference intervals and analytical measuring ranges, are presented below.

	Dimension® FT4L	Dimension® TSHL
Infants (01 - 23M)	0.93 - 1.45 ng/dL	0.867 – 6.43 µIU/mL
Children (02 - 12Y)	0.82 - 1.40 ng/dL	0.704 - 4.01 µIU/mL
Adolescents (13 - 20Y)	0.78 - 1.34 ng/dL	0.516 - 4.13 µIU/mL
Euthyroid Adults*	0.76 - 1.46 ng/dL	0.358 - 3.74 µIU/mL
Assay Range*	0.1 - 8.0 ng/dL	0.007 - 100 µIU/mL

		Table 4. Comparison of Pediatric and Adult 95% Reference Intervals

Information taken from existing Instructions for Use (Package Inserts)

A non-parametric approach was used to establish the reference intervals for children and adolescents where the 2.5" and 97.5" percentiles of the distribution of values were calculated. Because fewer than 120 patient samples were included for the infant age group, the reference intervals were calculated by using a robust measure of location and spread,

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as developed by Horn and Pesce and recommended in CLSI EP28-A3c: Defining. Establishing, and Verifying Reference Intervals.

The robust symmetrical method was used for the Dimension FT4L analysis because the data was normally distributed. The reference interval calculated from the actual data using the robust symmetrical method was confirmed with two simulated reference intervals (nonparametric and robust symmetric). Each simulated reference interval was estimated as the means of the 95% upper and lower bounds from 1000 data sets. In each case, a normal distribution was fitted to the actual results, with either n=120 for the non-parametric analysis, or n=77 for the robust symmetric analysis.

For the Dimension TSHL assay, the sample distribution for infant subjects was highly positively skewed. As permitted by CLSI EP28-A3, the actual results were natural log transformed to produce a well-fitted normal distribution. The infant reference intervals were then calculated using the robust symmetric method on the log transformed data. The reference interval was confirmed with two simulated reference intervals (nonparametric and robust symmetric). Each simulated reference interval was estimated as the means of the 95% upper and lower bounds from 1000 data sets. In each case, a normal distribution was fitted to the actual results, with either n=120 for the non-parametric analysis, or n=75 for the robust symmetric analysis.

The 90% confidence intervals for the Infant 95% Reference Intervals are listed below.

Infants (01 - 23M)	Dimension® FT4L	Dimension® TSHL
Calculation Method	Robust Symmetric	Robust Symmetric After LogTransformed
Reference Interval	0.93 - 1.45 ng/dL	0.867 - 6.43 µIU/mL
90% Confidence Intervalof Lower Limit	0.89 - 0.97 ng/dL	0.710 - 1.04 µIU/mL
90% Confidence Intervalof Upper Limit	1.41 - 1.50 ng/dL	5.40 - 7.54 µIU/mL

Table 5. Infant Reference Interval - 90% Confidence Intervals for Upper and Lower Limits

Performance Characteristics 8.

The inclusion of pediatric reference intervals in the Instructions for Use (Package Inserts) does not necessitate the collection of additional analytical performance data as no changes were made to the reagents. Therefore, all analytical performance data previously reviewed for the Dimension® FT4L and TSHL assays continue to apply to these assays. All performance data is cross-referenced to the predicate 510(k) submissions for the FT4L and TSHL assays (K130276 and K081074).

Specifically, the following studies are not needed for the purpose of this submission:

Precision/Reproducibility ■
. Linearity
l Calibrator/Assay Traceability
. Calibrator/Assay Stability
l Assay Cut-off
" Method Comparison
l Matrix Comparison

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י Sensitivity (Detection Limits, LoB, LoD, LoQ)
l Analytical Specificity

Shelf-Life 9.

The inclusion of pediatric reference intervals in the Instructions for Use (Package Inserts) does not necessitate the collection of additional stability data as no changes were made to the reagents. Therefore, all stability methods, acceptance criteria and data previously reviewed for the Dimension® FT4L and TSHL assays continues to apply to these assays.

Specifically, the following stability studies are not needed for the purpose of this submission:

י Shelf Life Stability
l Onboard Stability
l Open Vial Stability

10. Conclusions

The Dimension® FT4L and TSHL assays with pediatric reference intervals are substantially equivalent to the currently marketed Dimension® FT4L and TSHL assays.

No changes were made to the reagents. The inclusion of pediatric reference intervals in the Instructions for Use (Package Inserts) does not require a change in the device design or a change in the manufacturing process.

The addition of pediatric reference intervals for the Dimension® FT4L and TSHL assays is further supported by the following rationale:

1. Testing of pediatric patients is within the established indications for use in the diagnosis and treatment of thyroid disease), as described in 21 CFR §862.1695 and 21 CFR §862.1690.
1. The newly-established pediatric reference intervals are either within or are above the previously-established reference intervals for euthyroid (normal thyroid) adult populations and they are within the analytical measuring ranges of the Dimension® FT4L and TSHL assays. Therefore, the Dimension® FT4L and TSHL assays have appropriate analytical performance to test pediatric patients.

Regulation Number and Section

§ 862.1695 Free thyroxine test system.

(a)
Identification. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II.