The DiaSorin LIAISON® TSH assay is an in vitro chemiluminescent immunoassay intended for the quantitative determination of thyroid stimulating hormone (TSH), also known as thyrotropin and thyrotropic hormone, in human serum. The test has to be performed on the LIAISON® XL Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The DiaSorin LIAISON® Control Thyroid 1, LIAISON® Control Thyroid 2 and LIAISON® Control Thyroid 3 are intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® TSH assay.

Device Description

The DiaSorin LIAISON® TSH assay is an in vitro chemiluminescent immunoassay for the quantitative determination of thyroid stimulating hormone (TSH), also known as thyrotropin and thyrotropic hormone, in human serum. The test has to be performed on the LIAISON® XL Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The method for the quantitative determination of TSH is a sandwich chemiluminescence immunoassay. A specific mouse monoclonal antibody is coated on the magnetic particles (solid phase); another monoclonal antibody is linked to an isoluminol derivative (isoluminol-antibody conjugate). All assay steps and incubations are performed by the LIAISON® XL Analyzer.

Results are determined by a 2 point calibration conversion of the master curve to a working curve. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is inversely related to TSH concentration present in calibrators, patient samples or controls.

The LIAISON® Control Thyroid 1, 2 and 3 are prepared from human serum at target values of 0.5-0.78 mIU/L. 7.0-9.48 mIU/L and 42.7-57.7 mIU/L.

AI/ML Overview

The provided document describes the DiaSorin LIAISON® TSH assay, an in vitro chemiluminescent immunoassay for the quantitative determination of thyroid stimulating hormone (TSH) in human serum, and associated quality controls (LIAISON® Control Thyroid 1, 2, and 3). The submission aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" but rather describes various performance characteristics and their results, which serve as evidence of the device meeting certain performance standards for substantial equivalence. I will infer the acceptance criteria from the context of typical lab assay performance and the results presented.

Performance Characteristic	Acceptance Criteria (Inferred)	Reported Device Performance
Method Comparison	Good agreement with a commercially available immunoassay (predicate device or similar). Typically, R² near 1, slope near 1, and intercept near 0.	181 samples compared to a commercially available immunoassay. Passing & Bablok regression: y = 1.005x - 0.0030, R² = 0.9748. 95% CI for slope: 0.988 to 1.026. 95% CI for intercept: -0.0873 to 0.0411 mIU/L.
Reference Range	Establishment of a normal range for healthy individuals.	Established in 130 apparently healthy individuals: 0.357 – 4.789 mIU/L (Median: 1.438 mIU/L).
Reproducibility/Precision	Low coefficient of variation (%CV) for within-run and total precision across different concentrations (low, medium, high). Values typically less than 10-15% depending on concentration.	For 6 serum samples and 3 controls, total %CVs ranged from 0.3% to 5.5%. For example, control KC1 (0.6401 mIU/L) had a total %CV of 4.3%, and sample 6 (82.56 mIU/L) had a total %CV of 4.2%.
Linearity	Demonstration of a linear response across the measuring range. Typically, R² near 1, slope near 1, and intercept near 0 within the reportable range.	Linear from 0.02 mIU/L to 90 mIU/L. Passing & Bablok regression: y = 0.9807x + 0.0013, R² = 0.9997.
Limit of Blank (LoB)	LoB value established.	0.014 mIU/L
Limit of Detection (LoD)	LoD value established.	0.02 mIU/L
Limit of Quantitation (LoQ)	LoQ established, typically at < 20% CV.	0.02 mIU/L (defined as inter-assay precision of < 20% CV).
Interfering Substances	Non-significant interference (≤10% difference) with common endogenous and exogenous substances.	No significant interference (≤10% difference) reported for various substances including Triglycerides (500 mg/dL), Hemoglobin (250 mg/dL), Bilirubin (conjugated & unconjugated 5 mg/dL), Albumin (6000 mg/dL), and various hormones (LH, FSH, hGH, hCG, HAMA).
Traceability	Traceable to an international reference material.	Traceable to the WHO reference material: 2nd IRP WHO 80/558 standard.
Control Stability	Lyophilized controls stable until expiration. Reconstituted controls stable for specified period.	Lyophilized controls stable until expiration date. Reconstituted controls stable for up to 48 hours at 2-8°C, or up to 1 month frozen at -20°C.

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

Method Comparison: 181 samples. Data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but it is implied to be clinical human serum samples.
Reference Range/Expected Values: 130 apparently healthy human serum samples. Data provenance is not explicitly stated.
Reproducibility/Precision: A coded panel of 6 frozen serum samples (low, medium, high), plus 3 levels of LIAISON® Control Thyroid. The study was performed at DiaSorin Inc., suggesting a prospective in-house study.
Linearity: One high TSH sample serially diluted to generate 7 concentrations.
LoB/LoD/LoQ: Six serum specimens at low TSH doses, assayed in 72 determinations.
Interfering Substances: Not explicitly stated how many samples per substance, but implied to be controlled laboratory experiments.

The provenance (country of origin) is not provided for clinical samples. The studies for reproducibility, linearity, LoB/LoD/LoQ, and interfering substances appear to be prospective laboratory studies.

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

For this type of in vitro diagnostic device (quantitative immunoassay), the "ground truth" for the test set is established by the reference methods or established values, not human expert consensus.

Method Comparison: The predicate or commercially available immunoassay serves as the reference for comparison. No human experts are used for ground truth for individual samples; the accuracy of the comparator assay is assumed.
Reference Range: "Apparently healthy test subjects" were used. Their health status would have been determined by clinical criteria, likely by medical professionals (e.g., physicians) but specific numbers or qualifications of experts are not relevant or provided in this context.
Reproducibility/Precision, Linearity, LoB/LoD/LoQ, Interfering Substances, Traceability: These performance characteristics are evaluated against known standards, spiked samples, or by repeated measurements, not through expert consensus on individual results. The "ground truth" for these studies is typically defined by the experimental setup and reference materials.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers are part of the ground truth establishment (e.g., interpretation of medical images). This is not applicable to a quantitative immunoassay where numerical values are measured and compared against established analytical performance goals or a predicate device. The "adjudication" is based on statistical methods (e.g., Passing & Bablok regression, %CV calculations) comparing the device's numerical output to expected values or reference methods.

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

An MRMC study is not applicable as this is an in vitro diagnostic immunoassay, not an AI-assisted diagnostic imaging or interpretation device that involves human readers. Therefore, no such study was performed, and no effect size for human reader improvement with AI assistance is provided.

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

This device is an automated immunoassay system (LIAISON® XL Analyzer) that quantitatively determines TSH levels. Its performance is inherently "standalone" in the sense that the analyzer yields a numerical result without human interpretation of raw signals; human involvement is in sample loading, calibration, quality control, and result review. The studies described (Method Comparison, Precision, Linearity, LoB/LoD/LoQ, Interference) all evaluate the performance of the automated assay system in generating these numerical results.

7. The Type of Ground Truth Used

Method Comparison: The results obtained from a "commercially available immunoassay" (predicate or similar) served as the comparative truth.
Reference Range: Established by measuring TSH levels in "apparently healthy test subjects."
Reproducibility/Precision: Determined by repeated measurements of samples (frozen serum, controls) with expected concentrations.
Linearity: Established by serially diluting a high TSH sample, where the concentration of each dilution is known relative to the original sample.
LoB/LoD/LoQ: Established through statistical methods on samples with very low or zero analyte concentrations.
Interfering Substances: Established by comparing results from samples spiked with known interfering substances against unspiked control samples.
Traceability: Traceable to the WHO reference material: 2nd IRP WHO 80/558 standard.

In essence, the ground truth is based on reference methods, known concentrations of reference materials, and established clinical characteristics (e.g., healthy individuals).

8. The Sample Size for the Training Set

This document describes performance validation studies for a diagnostic assay, not a machine learning or AI model that typically has a distinct "training set." Therefore, a "training set" in that context is not applicable. The development of the assay itself would have involved extensive R&D and optimization, but those details are not provided as specific "training set" sizes here.

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

As noted above, the concept of a "training set" in the context of an AI/ML model with corresponding ground truth establishment is not directly applicable to this immunoassay device approval. The "ground truth" for the various analytical performance characteristics (e.g., linearity, precision, interference) are established via standard analytical chemistry and immunoassay validation practices using reference materials, spiked samples, and comparative methods, as described in point 7.

Summary

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K130469

5.0 510(k) SUMMARY

SUBMITTED BY:

Kelly R. Sauer Regulatory Affairs Specialist DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Phone (651) 351-5884 Fax (651) 351-5669 Email: kelly sauer@diasorin.com

NAME OF DEVICE:

Trade Name:

LIAISON® TSH LIAISON® Control Thyroid 1 LIAISON® Control Thyroid 2 LIAISON® Control Thyroid 3

Common Names/Descriptions:

Thyroid stimulating hormone

Classification Names:

Thyroid stimulating hormone test system: Class II 21 CFR 862.1690; Clinical Chemistry (75) Quality Control Material: Class I, reserved 21 CFR 862.1660; Clinical Chemistry (75)

Product Code:

PREDICATE DEVICE:

JLW, JJX

Roche Elecsys® TSH Assay Reference K961491 (Assay) Elecsys® PreciControl Universal Reference K090541 (Controls)

DEVICE DESCRIPTION:

INTENDED USE:

APR 0 5 2013

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KIT DESCRIPTION:

COMPARISON TO PREDICATE DEVICE:

The DiaSorin LIAISON TSH assay is substantially equivalent in principle and performance to the Roche Elecsys® TSH Test (K961491) which was FDA cleared July 22, 1996. The DiaSorin LIAISON® Control Thyroid 1, LIAISON® Control 2 and LIAISON® Control 3 are substantially equivalent in principle to the Roche Elecsys® PreciControl Universal (K090541).

Characteristic	New DeviceLIAISON® TSH	Predicate DeviceRoche Elecsys® TSH (K961491)
Intended Use	The DiaSorin LIAISON® TSHassay is a chemiluminescentimmunoassay (CLIA)intended for the quantitativedetermination of thyroidstimulating hormone (TSH),also known thyrotropin andthyrotropic hormone inhuman serum. The test mustbe performed on theLIAISON® XL Analyzer.	Immunoassay for the in vitroquantitative determination ofthyrotropin in human serum andplasma. TheelectrochemiluminescenceImmunoassay "ECLIA" is intended foruse on Elecsys and cobas eimmunoassay analyzers.
Indications for Use	Measurements of TSHproduced by the anteriorpituitary are used in thediagnosis of thyroid orpituitary disorders.	Same
Measured Analyte	Thyroid stimulating hormonealso known as thyrotropinand thyrotropic hormone	Same
Assay Type	ChemiluminescentImmunoassaySandwich principle	ElectrochemiluminescentimmunoassaySandwich principle
Calibration	Two-point verification ofstored master curve.	Same

Table 1: Table of Assay Similarities and Differences

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Standarization	2nd IRP WHO ReferenceStandard 80/558	Same
Reagent IntegralStorage	On-board or in refrigerator@2-8°C	Same
SampleHandling/Processing	Automated	Same
Conjugate Antibody	Mouse monoclonal anti-TSH	Same
Unit of Measure	mIU/L	µIU/mL or mIU/L (selectable)
Reference range	Serum - 0.357 - 4.789 mIU/L	Serum - 0.270 – 4.20 µIU/mL
Assay range ·	Reportable Range :0.02 to 90 mIU/L	Reportable Range :0.010 – 100 μIU/mL
Sample Matrix	Human serum	Human serum and plasma
Sample size	200 µL	50 μL
Assay time to firstresult	17 minutes	18 minutes
Open storage2-8°C	6 weeks	12 weeks
Open storageon analyzer	6 weeks	Same
Calibration Stability	Calibration is required every4 weeks	A calibration is required after 1 monthwhen using the same reagent lot,after 7 days when using the samereagent lot on the analyzer.
Calibrators	2 levels - Included in integral	2 levels - Not included with kit
Quality ControlsRecommended	3 levels	2 levels

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Characteristic	New DeviceLIAISON® Control Thyroid 1LIAISON® Control Thyroid 2LIAISON® Control Thyroid 3	Predicate DeviceElecsys® PreciControlUniversal (K090541)
Intended Use	Intended for use as assayedquality control samples tomonitor the accuracy andprecision of the DiaSorinLIAISON® TSH assay	Intended for use as qualitycontrol of Elecsys®immunoassays on the Elecsys®and Cobas® e immunoassayanalyzers
Matrix	Human serum	Same
Reagent Format	Lyophilized	Same
Storage	Unopened store at 2-8° C untilexpiration date	Same
Levels	Three concentrations :Low, medium, high	Two concentrations :Low and high
Reagent Format	4 vials x 5.0 mL each levelEach level provided separately	2 vials x 3.0 ml each level
Handling	Reconstitute with 5.0 mLdistilled waterand allow to stand 15 minutesbefore use	Reconstitute with 3.0 mLdistilled waterand allow to stand 30 minutesbefore use.
Open Storage	Reconstituted :48 hours at 2-8° CFor longer storage periods,frozen to -20 °C	Reconstituted :On analyzer at 20-25° C up to 5hrs ; 3 days at 2-8° C;-20° C for up to 1 month

PERFORMANCE DATA for the TSH Assay:

Method Comparison:

One hundred eighty-one (181) samples were tested by the LIAISON® TSH assay and a commercially available immunoassay. The method comparison study was performed according to CLSI EP9-A2 guideline. The samples ranged in concentration from 0.0257 to 89.56 mIU/L.

Results:

Passing & Bablok regression analysis was performed on the results across the range of LIAISON® TSH assay yielding agreement of y = 1.005x-0.0030, R2 = 0.9748. The 95% confidence interval for slope is 0.988 to 1.026 and 95 % confidence interval for the intercept is -0.0873 to 0.0411 mIU/L.

র্ব

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Reference Range/Expected Values:

Human serum samples from 130 apparently healthy test subjects were tested to determine the reference range for the LIAISON® TSH assay.

Apparently Healthy Test Subjects	Median	Observed 95% Normal Range
Serum (130)	1.438 mIU/L	0.357 – 4.789 mIU/L
Consider these limits as guidelines only. Each laboratory should establish its own reference range

Reproducibility/Precision:

A twenty day precision study was performed at DiaSorin Inc.. A coded panel comprised of 6 frozen serum samples was prepared. The coded panel contained 2 of each level of low, medium and high samples which span the measuring range of the assay. The LIAISON® Control Thyroid (3 levels) were also tested in the study. The CLSI document EP5-A2 was consulted in the preparation of the testing protocol.

The precision panel samples and kit controls were tested on two lots of LIAISON® TSH assay in two replicates per run, 2 runs per day for 20 operating days for a total of 160 replicate results per sample.

The mean, standard deviation, and coefficient of variation (%CV) of the results were computed for each of the tested specimens.

Results:

The 20 day results are summarized in Table 1 as sample overall mean TSH concentration in mIU/L, computed SDs and %CVs for within run and total across lots.

Sample ID	N	MeanmIU/L	BetweenLot / Within-Site		TotalAcross Lots /Within Sites
			SD	%CV	SD	%CV
KC 1	160	0.6401	0.03	4.1%	0.03	4.3%
KC 2	160	8.140	0.19	2.4%	0.39	4.8%
KC 3	160	47.61	0.24	0.5%	2.55	5.4%
Sample 1	160	0.2660	0.01	3.6%	0.01	5.5%
Sample 2	160	1.201	0.03	2.3%	0.05	3.8%
Sample 3	160	4.702	0.07	1.4%	0.20	4.3%
Sample 4	160	28.47	0.35	1.2%	1.01	3.6%
Sample 5	160	46.19	0.25	0.5%	1.80	3.9%
Sample 6	160	82.56	0.21	0.3%	3.47	4.2%

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Linearity:

The linearity for LIAISON® TSH assay was determined, based on guidance from CLSI protocol EP6-A. A high TSH sample was serially diluted with LIAISON® Endocrinology Diluent to generate 7 concentrations across the range 0.0150 to 91.3 mIU/L.

Results:

Passing & Bablok regression analysis was performed on the results yielding agreement of y = 0.9807x+0.0013, R2 = 0.9997. The linearity was measured on the LJAJSON® XL Analyzer and has been demonstrated to be linear from 0.02 mIU/L to 90 mIU/L.

LoB/LoD/LoQ:

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined according to CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline June 2012- Second Edition.

LoQ is defined as inter-assay precision of < 20% CV. It was calculated by testing six serum specimens at low TSH doses and assayed in 72 determinations on two different kit lots and two different instruments over three days of testing. The mean, standard deviation, and %CV was then determined for each sample.

Results:

Limit of Blank: 0.014 mIU/L Limit of Detection: 0.02 mIU/L Limit of Quantitation: 0.02 mIU/L

Interfering Substances:

Controlled studies of potentially interfering substances and cross reactants showed no interference at the concentration for each substance listed below in the LIAISON® TSH assay. The testing was based on CLSI-EP7-A2. Non-significant interference and crossreactivity is defined as ≤10% difference between tested and control samples.

Substance	TestedConcentration
Triglycerides	500 mg/dL
Hemoglobin	250 mg/dL
Unconjugated bilirubin	5 mg/dL
Conjugated bilirubin	5 mg/dL
Albumin	6000 mg/dL

Potential Interfering Substances

Section 5

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Substance	Tested Concentration
Luteinizing Hormone (LH)	1000 mIU/mL
Follicle-stimulating hormone (FSH)	5000 mIU/mL
Human Growth Hormone (hGH)	100 ng/mL
Human Chorionic Gonadotropin (hCG)	200000 mIU/mL
HAMA	1268 ng/mL

Potential Interfering Cross reactants

Traceability:

The DiaSorin LIAISON® TSH assay is traceable to the WHO reference material: 2nd IRP WHO 80/558 standard.

LIAISON® Control Thyroid 1, LIAISON® Control Thyroid 2, and LIAISON® Control Thyroid 3:

1. Device Description: The LIAISON® Control Thyroid 1, 2 and 3 are prepared from human serum at target values of 0.5-0.78 mIU/L. 7.0-9.48 mIU/L and 42.7-57.7 mIU/L.
1. Stability: The stability of the kit and controls are based on real-time stability study data of one kit lot. Once opened, the kit is stable for 6 weeks at 2-8℃. The sponsor claimed that the kit and calibrators are stable for 6 weeks on-board the LIAISON® XL analyzer and the sponsor requires that it is calibrated every 4 weeks.

Control Stability: Lyophilized controls are stable until the expiration date shown on the product labeling when stored as instructed.

Reconstituted controls are stable for up to 48 hours when stored at 2-8°C. For longer storage periods, control aliquots should be frozen to -20°C.

1. Value assignment: A minimum of 60 valid test results for each control are used in the range assignment. The LIAISON® Control Thyroid 1, LIAISON® Control Thyroid 2, LIAISON® Control Thyroid 3 are tested on a minimum of 3 LIAISON® XL Analyzers, using / different approved LIAISON® TSH assay kit lots, at a minimal time period of 3 days. The mean value and the standard deviation (std) is calculated from the test results.
  The target value of the controls is given by the calculated mean value +/- 3 std.

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DiaSorin LIAISON® TSH Premarket Notification

CONCLUSION:

. .

The material submitted in this premarket notification is complete and supports the basis for substantial equivalence to the Roche Elecsys® TSH (K961491) The labeling is sufficient and satisfies the requirements of 21 CFR Part 809.10.

Section 5

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

April 5, 2013

DiaSorin, Inc C/O Kelly R. Sauer 1951 Northwestern Avenue P. O. Box 285 STILLWATER MN 55082-0285

Re: K130469

Trade/Device Name: LIAISON® TSH LIAISON® Control Thyroid 1 LIAISON® Control Thyroid 2

LIAISON® Control Thyroid 3 Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: II Product Code: JLW, JJX Dated: February 22, 2013 Received: March 1. 2013

Dear Kelly Sauer:

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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2- Kelly Sauer

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the 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 regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Carol (@Beinson -S for

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 Form

510(k) Number (if known): K130469

Device Name:

LIAISON® TSH LIAISON® Control Thyroid 1 LIAISON® Control Thyroid 2 LIAISON® Control Thyroid 3

Indications for Use:

Prescription Use X AND/OR Over-The-Counter Use __ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)

YungW.Chan-S

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k) K130469

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.