The DiaSorin LIAISON® Testosterone assay is a direct, competitive, chemiluminescence immunoassay (CLIA) intended for the quantitative determination of testosterone in human serum and plasma on the LIAISON®Analyzer. The assay is intended for in vitro diagnostic use.

Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in male subjects and, in female subjects hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

The DiaSorin LIAISON® Testosterone Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® Testosterone immunoassay.

Device Description

The LIAISON® Testosterone assay's method for quantitative determination of testosterone is a direct, competitive, chemiluminescence immunoassay (CLIA). Specific antibody to testosterone is bound to magnetic particles (solid phase) and testosterone is linked to an isoluminol derivative. During the incubation, testosterone is dissociated from its binding protein and competes with labeled testosterone for binding sites on the antibody. After the incubation, the unbound material is removed with a wash cycle, Subsequently, the starter reagents are added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is inversely proportional to the concentration of testosterone present in calibrators, controls, or samples. All assay steps and incubations are performed by the LIAISON® Analvzer.

Two point kit calibrators are used to establish specific working curves based on assay master curves stored on the Analyzer.

The LIAISON® Testosterone reagent kit consists of a reagent intrgral which contains antibody coated magnetic particles (2.3 mL), conjugate (12 mL) and assay buffer (12 mL) reagents. Two levels of ready to use calibrators (2 vials each level, 2.0 mL per vial) are provided with each kit. Each kit consists of 100 tests.

AI/ML Overview

The DiaSorin LIAISON® Testosterone assay and Control Set are subject to a 510(k) premarket notification for substantial equivalence to a predicate device. This submission outlines performance data to demonstrate that the device meets acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a separate, defined set of thresholds for each performance metric, but rather presents the results of various studies and compares them to the predicate device and established guidelines (e.g., CLSI guidelines). The performance data implicitly serves as the evidence that the device meets the necessary standards for its intended use.

Here's a summary of the reported device performance:

Performance Metric	Reported Device Performance (LIAISON® Testosterone)	Implicit Acceptance Criteria (based on predicate and guidelines)
Method Comparison	Passing & Bablok linear regression: y = 0.9458x - 0.1002, R = 0.990. 95% CI for slope: 0.92 to 0.96. 95% CI for intercept: -1.88 to 1.80 ng/dL.	Strong correlation (R-value close to 1) and good agreement in results with the predicate device (slope close to 1, intercept close to 0) in accordance with CLSI EP9-A2 guidelines.
LoB	≤ 3.1 ng/dL	Determined according to CLSI EP17-A. Represents the lowest analyte concentration likely to be reported as greater than zero.
LoD	9.8 ng/dL	Determined according to CLSI EP17-A. Represents the lowest analyte concentration detectable with reasonable statistical certainty.
LoQ	16.0 ng/dL	Determined according to CLSI EP17-A. Represents the lowest analyte concentration at which the assay provides acceptable accuracy and precision.
Measuring Range	16.0 - 1500 ng/dL (Also mentioned in comparison to predicate: 16.0 - 1500 ng/dL vs. 2.5 - 1500 ng/dL for Roche Cobas®)	Demonstrated capability to accurately and precisely quantify testosterone within this range, clinically relevant to the intended use. Similar to or better than predicate where appropriate.
Reproducibility/Precision	Within Run %CV: < 8% (ranging from 2.8% to 7.3% for various samples/levels). Total Across Lots/Sites %CV: < 15% (ranging from 7.1% to 14.0% for various samples/levels). Samples Level 1 and 2 (controls) had Total %CV of 9.1% and 7.1% respectively.	Low variability (low %CV) for both within-run and total precision, indicating consistent and reliable results. Acceptable levels are typically defined by CLSI guidelines (e.g. EP5-A2) and industry standards for diagnostic devices.
Dilution Linearity	Serum: y = 1.0269x - 0.6135, R2 = 0.9862. SST Serum: y = 1.0096x - 0.3.297, R2 = 0.9907. EDTA plasma: y = 0.9986x + 15.91, R2 = 0.9847.	Strong linearity (R2 close to 1) across the measuring range, indicating accurate results when samples are diluted. In accordance with CLSI EP6-A.
Specificity	Cross-reactivity observed to be generally low for most tested substances. Notably, 11-B-Hydroxytestosterone had < 15.28% and 11-Keto-testosterone had < 37.70%. Other listed substances demonstrated very low (< 0.01% to < 4.27%) cross-reactivity.	Cross-reactivity should be minimal to avoid false positives or inaccurate measurements due to structurally similar compounds. The specific thresholds would depend on the clinical impact of misidentification for each substance.
Interfering Substances	No interference observed at tested concentrations for Hemoglobin (600 mg/dL), Bilirubin (unconj, 20 mg/dL), Triglycerides (1000 mg/dL), Cholesterol (500 mg/dL), HAMA (Up to 1753 ng/mL).	No significant bias or effect on results when common endogenous or exogenous interfering substances are present at clinically relevant concentrations, in accordance with CLSI-EP07-A2.
Reference Range	Established for four populations (Males 18-49, Males ≥ 50, Females 18-49, Females ≥ 50) with corresponding median concentrations and central 95% intervals.	Clinically appropriate and robust reference intervals for different demographic groups, established according to CLSI Approved Guideline C28-A3.

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

Method Comparison: One hundred eighty-four (184) serum samples were initially tested. One sample was above the upper limit, and 21 samples were below the measuring range of the LIAISON® Testosterone assay and were excluded. Therefore, 162 serum samples were used for the analysis.
- Data Provenance: Not explicitly stated, but clinical samples (human serum) used to span the reportable range of each assay. Implied to be retrospective as they were collected and then analyzed. The country of origin is not specified.
Reproducibility/Precision: A coded panel comprised of 6 frozen serum samples (2 low, 2 medium, 2 high) and 2 levels of LIAISON® Testosterone Controls were tested. The total number of measurements for each sample/control across all sites and runs was 480.
- Data Provenance: DiaSorin Inc. prepared the coded panel. Testing was performed at DiaSorin Inc. and 2 external sites. Implied to be prospective for the purpose of the study. The country of origin is not specified.
LoB/LoD/LoQ: Sample size not explicitly stated for this particular determination, but it generally involves multiple replicates of blank and low-concentration samples.
- Data Provenance: Not specified.
Reference Range/Expected Values:
- Males 18-49 years: N=161
- Males ≥ 50 years: N=132
- Females 18-49 years: N=202
- Females ≥ 50 years: N=127
- Data Provenance: Human serum samples from "apparently healthy adults." Implied to be clinical samples, likely prospective for the purpose of establishing reference ranges. The country of origin is not specified.
Dilution Linearity: Three (3) samples of each sample type (serum, SST serum, EDTA plasma) were used, diluted to span the measuring range.
- Data Provenance: Not specified.
Specificity and Interfering Substances: Tested by adding known substances to serum pools. Sample size refers to the number of substances tested rather than individual patient samples.
- Data Provenance: Not specified.

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

This device is an in vitro diagnostic (IVD) assay for quantitative determination of a hormone (testosterone). The "ground truth" for such devices is established by reference methods, comparison with predicate devices, and the inherent chemical/biological properties of the analytes. It does not involve human expert interpretation of images or clinical data for individual cases in the same way as, for example, an AI imaging device.

No "experts" in the sense of clinicians or radiologists establishing ground truth for individual cases are mentioned or relevant for this type of device.
The ground truth for the method comparison study is implicitly the results obtained from the predicate device, the Roche Cobas® Testosterone II Test (K093421), run on the Elecsys analyzer, which is a previously cleared and accepted method for testosterone measurement.

4. Adjudication Method for the Test Set:

Not applicable. As this is an IVD assay measuring an analyte, there is no adjudication process involving multiple human observers for results. The accuracy is determined by analytical performance against known standards and comparison with accepted methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices (e.g., imaging AI) where human readers are making diagnoses. For an IVD assay, the performance is evaluated on its analytical accuracy and precision.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:

Yes, the studies presented (Method Comparison, LoB/LoD/LoQ, Reproducibility/Precision, Dilution Linearity, Specificity, Interfering Substances, Reference Range) all represent the standalone performance of the DiaSorin LIAISON® Testosterone assay without human interpretation or intervention in the measurement process itself, beyond the standard operation of the instrument. The results (e.g., testosterone concentration in ng/dL) are automatically generated by the LIAISON® Analyzer.

7. The Type of Ground Truth Used:

Method Comparison: The results from the predicate device (Roche Cobas® Testosterone II Test) were used as the reference "ground truth" for comparison.
Reproducibility/Precision, LoB/LoD/LoQ, Dilution Linearity, Specificity, Interfering Substances: These studies use analytically derived ground truth, often involving:
- Known concentrations of analytes (e.g., spiked samples for specificity, control materials).
- Reference materials.
- Statistical methods to determine limits.
- Comparison to expected values from dilution series.
Reference Range/Expected Values: Healthy human serum samples were used to establish the statistical distribution of testosterone in various populations, serving as the "ground truth" for normal physiological ranges.

8. The Sample Size for the Training Set:

This document describes a 510(k) submission for a chemiluminescence immunoassay (CLIA), which is a traditional laboratory-based analytical device, not an AI/Machine Learning model. Therefore, the concept of a "training set" in the context of machine learning is not applicable.

The assay's "training" or calibration relies on a master curve stored on the Analyzer and specific working curves established with two-point kit calibrators provided with each kit. These calibrators contain known concentrations of testosterone.

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

As noted above, this is not an AI/ML device, so there is no "training set" in that sense. The "ground truth" for the calibrators (which are analogous to the data used to "train" a traditional assay) is established through:

Manufacturing and Analytical Certification: Calibrators are precisely manufactured with known, certified concentrations of testosterone. These concentrations are typically determined using highly accurate reference methods (e.g., isotope dilution mass spectrometry - ID-MS), which serve as the gold standard for analyte quantification.
Master Curves: The assay relies on a "master curve" stored on the LIAISON® Analyzer. This master curve is developed using a comprehensive set of reference materials with certified testosterone concentrations to define the relationship between the signal (RLU) and the analyte concentration across the entire measuring range. The two-point calibrators then adjust this master curve for each specific kit and run to account for minor variations.

Summary

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122793

DiaSorin LIAISON® Testosterone Premarket Notification

JAN 2 5 2013

5.0 510(k) SUMMARY

SUBMITTED BY:

Sandra M. Zimniewicz Requlatory Affairs Specialist DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Phone (651) 351-5711 Fax (651) 351-5669 Email: sandra.zimniewicz@diasorin.com

NAME OF DEVICE:

Trade Name:

LIAISON® Testosterone LIAISON® Testosterone Control Set

Common Names/Descriptions:

Classification:

Testosterone Assay

Class I, reserved, 21 CFR 862.1680. Testosterone Test System, Clinical Chemistry (75)

Class I, reserved, 21 CFR 862,1660, Quality Control Material, Clinical Chemistry (75)

Product Code:

PREDICATE DEVICE:

CDZ. JJX

Roche Cobas® Testosterone II Test Reference K093421 Roche Elecsys® PreciControl Universal Reference K090541

DEVICE DESCRIPTION:

INTENDED USE:

The DiaSorin LIAISON® Testosterone is a direct, competitive, chemiluminescence immunoassay (CLIA) intended for the quantitative determination of testosterone in human serum and plasma on the LIAISON® Analyzer. The assay is intended for in vitro diagnostic use.

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·The DiaSorin LIAISON® Testosterone Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® Testosterone immunoassav.

KIT DESCRIPTION:

Two point kit calibrators are used to establish specific working curves based on assay master curves stored on the Analyzer.

COMPARISON TO PREDICATE DEVICE:

The DiaSorin LIAISON® Testosterone is substantially equivalent in principle and performance to the Roche Cobas® Testosterone II Test (K093421) which was FDA cleared 4/28/2010.

Characteristic	LIAISON® Testosterone	Roche Cobas®Testosterone II(K093421)
Intended Use	Intended for the in vitroquantitative determination oftestosterone in human serumand EDTA plasma.	Intended for the in vitroquantitative determination oftestosterone in human serumand plasma.
Indications forUse	Measurement of testosterone isused in the diagnosis andtreatment of disorders involvingthe male sex hormones(androgens), including primaryand secondary hypogonadism,delayed or precocious puberty,impotence in males and, infemales hirsutism (excessivehair) and virilization(masculinization) due to	Measurements of testosteroneare used in the diagnosis andtreatment of disorders involvingthe male sex hormones(androgens), including primaryand secondary hypogonadism,delayed or precocious puberty,impotence in males and, infemales hirsutism (excessivehair) and virilization(masculinization) due to

DiaSorin LIAISON® Testosterone Similarities and Differences

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	tumors, polycystic ovaries, andadrenogenital syndromes.	tumors, polycystic ovaries, andandrogenital syndromes.
Assay Type	ChemiluminescentImmunoassay	ElectrochemiluminescenceImmunoassay "ECLIA"
Analyte	Testosterone	Testosterone
Calibration	Two-point verification of storedmaster curve.	Same
Sample Handling	Automated	Same
Unit of Measure	ng/mL,ng/dL or nmol/L	Same
Controls	2 levels	2 levels
Measurement System	Photomultiplier (flashchemiluminescence reader)	Photomultiplier (flashchemiluminescence reader)
Calibrators	Included with kit	Provided separately
Capture Antibody	Mouse monoclonal antibodiesto testosterone	Biotinylated sheep monoclonalantibodies to testosterone
Measuring range	16.0 - 1500 ng/dL	2.5 - 1500 ng/dL
Sample size	100 uL	20 uL
Sample matrix	Serum and EDTA plasma	Serum and plasma (Li-heparin,K2-EDTA, and K3 EDTA
Reagent Storage	In refrigerator @ 2-8° C.	On analyzer or in refrigerator@ 2-8°C.
Open Storage @2-8° C	4 weeks	12 weeks
Open Storage onanalyzer	NA	8 weeks

DiaSorin LIAISON® Testosterone Control Set Similarities and Differences

Characteristic	LIAISON® TestosteroneControl Set	Roche PreciControl Universal1 and 2 (K090541)
Intended Use	Intended for use as assayquality control samples tomonitor the accuracy andprecision of the DiaSorinLIAISON® Testosteroneimmunoassay.	Intended for use as qualitycontrol of Elecsys®immunoassays on the Elecsys®and Cobas® immunoassayanalyzers®
Matrix	Human serum	Same
Levels	Two concentrations :low and high	Same
Reagent Format	Liquid2 vials x 3.5 mL each level	Lyophilized2 vials x 3.0 ml each level
Handling	Ready to use	Reconstitute with distilled waterand allow 30 minutes forreconstitution.
Storage @ 2-8° C	Unopened store at 2-8° C untilexpiration date	Same

Page 5 - 3

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PERFORMANCE DATA:

Method Comparison:

The method comparison included one hundred eighty four (184) serum samples that spanned the reportable range of each assay (n = 184). Samples were tested by the DiaSorin LIAISON® Testosterone assay (expressed as ng/dL) and the predicate device Roche Cobas® Testosterone II Test (K093421) on the Elecsys analyzer (expressed as ng/dL). The method comparison study was performed according to CLSI EP9-A2 quidelines.

One hundred sixty two (162) of the 184 serum samples tested were analyzed. One sample read above the upper limit of the reportable range and 21 samples read below the measuring range of the LIAISON® Testosterone assay and therefore, were not included in the analysis. Individual testosterone results were plotted.

Passing & Bablok linear regression analysis was performed on the results across the measuring range of LIAISON® Testosterone assay yielding agreement of y = 0.9458x -0.1002, R = 0.990. The 95% confidence interval for the slope was 0.92 to 0.96, and the 95% confidence interval for the intercept was -1.88 to 1.80 ng/dL.

LoB/LoD/LoQ

The Limit of Blank, Limit of Detection, and Limit of Quantitation were determined according to CLSI EP17-A: Protocols for Determination of Limits of Detection and Limits of Quantitation.

The following limits were determined with the LIAISON® Testosterone assay:

Limit of Blank: ≤ 3.1 ng/dL Limit of Detection: 9.8 ng/dL Limit of Quantitation: 16.0 ng/dL

Reference Range/Expected Values:

The reference range study was performed according to CLSI Approved Guideline C28-A3. Human serum samples from apparently healthy adults were tested to determine the reference range for the LIAISON® Testosterone assay into the follwoing gender and age groups.

Population	N	Median TestosteroneConc. ng/mL (ng/dL)	Central 95% Intervalng/mL (ng/dL)
Males 18-49 years	161	4.39 (439)	1.20 - 10.19 (120 – 1019)
Males ≥ 50 years	132	4.53 (453)	1.95 - 8.95 (195 – 895)
Females 18-49 years	202	0.24 (24.0)	< 0.16 - 0.73 (<16.0 – 73.0)
Females ≥ 50 years	127	0.22 (22.0)	< 0.16 - 0.51 (<16.0 – 51.0)

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Reproducibility/Precision:

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

Results:

The twenty day results for all three sites are summarized in Table 1 as sample overall mean testosterone concentration in ng/dL, computed SDs and %CVs for within run and total across lots and across sites.

SampleID	N	Mean(ng/dL)	Within RunSD	Within Run%CV	TotalAcross Lots / AcrossSites SD	TotalAcross Lots / AcrossSites %CV
Level 1	480	219	8.0	3.4%	2.0	9.1%
Level 2	480	781	22.0	2.8%	55.0	7.1%
POOL 1	480	37.0	3.0	7.3%	5.0	14.0%
POOL 2	480	83.0	5.0	5.5%	9.0	10.5%
POOL 3	480	237	11.0	4.5%	20.0	8.6%
POOL 4	480	418	18.0	4.3%	38.0	9.2%
POOL 5	480	1048	37.0	3.5%	94.0	9.0%
POOL 6	480	1325	42.0	3.2%	105	7.9%

Table 1: Reproducibility/Precision Results – 20 day Combined 3 Sites

Dilution Linearity:

Three (3) samples of each sample type, serum, SST serum, and EDTA plasma were diluted with calibrator matrix or a low human serum or plasma sample to yield sample concentrations that spanned the measuring range (16.0 – 1500 ng/dL) and analyzed by the LIAISON® Testosterone following CLSI EP6-A.

The mean results for each sample type were analyzed by a linear regression of Observed Testosterone Concentration versus Expected Testosterone Concentration in ng/dL with the following resulting equations:

Serum: v = 1.0269x - 0.6135. R2= 0.9862 SST Serum: y = 1.0096x - 0.3.297, R2= 0.9907 EDTA plasma: y = 0.9986x + 15.91, R2= 0.9847

Specificity

The cross-reactivity of the LIAISON® Testosterone assay was evaluated by adding the following substances to serum pools containing testosterone at 2 concentrations. The

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samples were analyzed and the percent (%) cross-reactivity calculated using the following formula:

% Cross-reactivity'= (Corrected Assay value/Concentration Spiked)*100

The observed cross-reactivities are listed below:

	Spiked Concentration	% Cross
Cross reactant	ng/mL	reactivity
Androstenedione	100	< 4.27
Cortisol	1000	< 0.03
Cortisone	2000	< 0.01
Danazol	1000	<0.02
Dexamethasone	2000	< 0.01
DHEA	1000	< 0.02
DHEA-S	50000	< 0.01
D-5-Androstene-3B-17B-diol	1000	< 0.06
Estrone	1000	< 0.03
Ethisterone	1000	< 0.43
Nandrolone	100	< 3.33
Norgesterel	1000	< 0.02
Testosterone propionate	50	< 7.48
5-a-Androstane-3B,17B-diol	500	< 0.81
5-a-Dihydrotestosterone	500	< 2.37
11-B-Hydroxytestosterone	50	< 15.28
11-Keto-testosterone	10	< 37.70
Prednisone	1000	< 0.03
Prednisolone	1000	< 0.04
Progesterone	1000	< 0.12
17-a-Estradiol	1000	< 0.02

Interfering Substances

Controlled studies of potentially interfering substances at two testosterone levels showed no interference at the concentration for each substance listed below in the LIAISON® Testosterone assay. The testing was based on CLSI-EP07-A2.

Substance	Tested Concentration
Hemoglobin	600 mg/dL
Bilirubin (unconj)	20 mg/dL
Triglycerides	1000 mg/dL
Cholesterol	500 mg/dL
HAMA	Up to 1753 ng/mL

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CONCLUSION:

The material submitted in this premarket notification is complete and supports the basis for substantial equivalence to the Roche Cobas® Testosterone II Test (K093421). The labelling is sufficient and satisfies the requirements of 21 CFR 809.10.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized depiction of an eagle or bird-like figure with three wing-like extensions. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

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

January 25, 2013

Diasorin, Inc. c/o Mr. John Eskdale 1951 Northwestern Ave. Stillwater, MN 55082

Re: K122793

Trade/Device Name: LIAISON Testosterone LIAISON Testosterone Control Set Regulation Number: 21 CFR 862.1680 Regulation Name: Testosterone test system Regulatory Class: Class I, reserved . x x = = = = 16% Product Code: CDZ, JJX Dated: December 14, 2012 Received: December 17, 2012

Dear Mr. Eskdale:

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 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.

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Page 2-Mr. Eskdale

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 C. Benson 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

510(k) Number (if known): K122793

Device Name: LIAISON® Testosterone and LIAISON® Testosterone Control Set

Indications for Use:

The DiaSorin LIAISON® Testosterone Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® Testosterone immunoassay.

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 Diagnostics and Radiological Health (OIR)

Yung W. Chan -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K122793

Regulation Number and Section

§ 862.1680 Testosterone test system.

(a)
Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.(b)
Classification. Class I.