LIAISON Testosterone xt

K201908 · DiaSorin, Inc. · CDZ · Oct 15, 2020 · Clinical Chemistry

Device Facts

• Record ID: K201908
• Device Name: LIAISON Testosterone xt
• Applicant: DiaSorin, Inc.
• Product Code: CDZ · Clinical Chemistry
• Decision Date: Oct 15, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1680
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The LIAISON® Testosterone xt is an in vitro diagnostic chemiluminescence immunoassay (CLIA) for the quantitative determination of testosterone in human serum and plasma (K2EDTA, Li-heparin, Na-heparin). Measurements 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, cryptorchidism, ovarian hyperandrogenism (e.g., polycystic ovarian syndrome, hirsutism, virilization), and erectile dysfunction.

Device Story

LIAISON® Testosterone xt is an in vitro diagnostic chemiluminescence immunoassay (CLIA) for quantitative testosterone measurement in human serum/plasma; used in clinical laboratories by trained personnel. Device utilizes automated analyzer platform to process patient samples; measures testosterone levels to assist clinicians in diagnosing/managing androgen-related disorders. Modifications from predicate include extended assay measuring range (0.024–15.0 ng/mL), increased open-use stability for reagents/calibrators (8 weeks), and extended calibration curve stability (4 weeks). Output provides quantitative testosterone concentration; aids clinical decision-making regarding hormonal status and treatment efficacy.

Clinical Evidence

Bench testing only. Verification and validation activities performed to support extended measuring range, reagent/calibrator stability, and calibration curve stability. No clinical data provided.

Technological Characteristics

Direct competitive CLIA; magnetic microparticle solid phase; isoluminol-labeled conjugate. Reagents: mouse monoclonal anti-testosterone antibody, phosphate buffer, BSA, surfactant, Proclin® 300, sodium azide. Dimensions/form factor: unitized Reagent Integral for 100 tests. Energy source: LIAISON® XL Analyzer (photomultiplier detection). Connectivity: automated system. Sterilization: N/A (in vitro diagnostic reagent).

Indications for Use

Indicated for quantitative determination of testosterone in human serum and plasma to aid in diagnosis and treatment of androgen-related disorders, including hypogonadism, puberty disorders, cryptorchidism, ovarian hyperandrogenism, and erectile dysfunction in adult and pediatric populations.

Regulatory Classification

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.

Predicate Devices

• LIAISON® Testosterone (k122793)

Submission Summary (Full Text)

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October 15, 2020

DiaSorin Inc. Mari Meyer Vice President, Regulatory and Clinical Affairs, North America 1951 Northwestern Avenue Stillwater, MN 55082

Re: K201908

Trade/Device Name: LIAISON® Testosterone xt Regulation Number: 21 CFR 862.1680 Regulation Name: Testosterone Test System Regulatory Class: Class I, reserved Product Code: CDZ Dated: September 15, 2020 Received: September 18, 2020

Dear Mari Meyer:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K201908

Device Name LIAISON® Testosterone xt

#### Indications for Use (Describe)

The LIAISON® Tectosterone xt is a direct, competitive, chemiluminescence immunoassay (CLIA) intended for the quantitative determination of testosterone in human serum and EDTA plasma on the LIAISON® XL 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 males and, in females hirsutism (excessive hair) and virilization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

The test has to be performed on the LIAISON® XL Analyzer.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# SECTION 6.0 510(k) SUMMARY

This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.

# 6.1. SUBMITTER INFORMAITON

| Submitter: | DiaSorin Inc.<br>1951 Northwestern Avenue<br>P.O. Box 285<br>Stillwater, MN 55082-0285 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mari Meyer<br>Vice President, Regulatory and Clinical Affairs<br>Email: [e-mail]<br>Phone: [phone]<br>Fax:<br>[phone] |
| Date Summary Prepared: | July 02, 2020 |

# 6.2. DEVICE INFORMATION

| Proprietary Name: | LIAISON® Testosterone xt (k201908) |
|-------------------|------------------------------------|
| Common Name: | Testosterone test system |
| Predicate Device: | LIAISON® Testosterone (k122793) |

# 6.3. REGULATORY INFORMATION

| Proprietary Name | Classification Name | Regulation<br>Section | Product<br>Code | Device<br>Class | Classification<br>Panel |
|------------------------------------------|---------------------------------------------------------------|-----------------------|-----------------|----------------------|-------------------------------|
| LIAISON®<br>Testosterone xt<br>(k201908) | Radioimmunoassay,<br>Testosterones And<br>Dihydrotestosterone | 862.1680 | CDZ | Class I,<br>Reserved | Clinical<br>Chemistry<br>(75) |

# 6.4. DEVICE DESCRIPTION

# PRINCIPLE OF PROCEDURE

The fundamental scientific technology (Principle of the device as described in its current labeling has not changed as a result of the modifications.

The LIAISON® Testosterone xt 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.

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# DEVICE CONTENT

The raw materials, formulation, and manufacturing procedures of the assay components have not changed as a result of the modifications.

# Reagent Integral

The LIAISON® Testosterone xt is an in vitro diagnostic device consisting of reagents provided in individual compartments within a plastic container called the Reagent Integral. The components provided in the unitized Reagent Integral include: PMP (paramagnetic particles), conjugate and assay buffer. All reagents in the integral are supplied ready to use. The assay configuration for the LIAISON® Testosterone xt allows for the performance of 100 tests.

#### Additional Components Not on the Reagent Integral

The two-point calibrators are provided in the same kit box, but separate from the Reagent Integral. The two-point calibrators are supplied ready to use.

#### Materials Required but Not Provided

The LIAISON® Testosterone xt assay is performed on the LIAISON® XL Analyzer (Model 10050; originally FDA cleared under k103529), a fully automated system with continuous loading combining the chemiluminescence technology with magnetic microparticles as the solid phase. Other accessories/consumables such as the LIAISON® XL Cuvettes, LIAISON® XL Starter Kit, LIAISON® Wash/System Liquid, LIAISON® XL Waste Bags, and the LIAISON® XL Disposable Tips are supplied separately.

# 6.5. INTENDED USE /INDICATIONS FOR USE

The Intended Use/Indications for Use of the device as described in its current labeling has not changed as a result of the modifications.

The LIAISON® Testosterone xt is a direct, competitive, chemiluminescence immunoassay (CLIA) intended for the quantitative determination of testosterone in human serum and EDTA plasma on the LIAISON® XL 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 males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

The test has to be performed on the LIAISON® XL Analyzer.

# 6.6. REASON FOR SUBMISSION

This Special 510(k) is being filed to seek FDA clearance for the LIAISON® Testosterone xt assay, a modified version of the existing LIAISON® Testosterone assay, which is currently cleared (k122793, FDA cleared on January 25, 2013).

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# 6.7. DESCRIPTION OF DEVICE MODIFICATION

The LIAISON® Testosterone device is being modified to extend the assay measuring range, calibration curve stability, and open use stability for the reagent integral and calibrators. Additionally, the modified device has a new proprietary name, part number, and is performed on the LIAISON® XL Analyzer. The modifications do not change the Intended Use/Indications for Use, the fundamental scientific technology, reagent formulation, assay configuration, manufacturing procedures, principle of operation, or safety and effectiveness of the device.

A summary of the modifications and the rationale for the changes between the current cleared device, LIAISON® Testosterone (k122793) and the LIAISON® Testosterone xt (modified device) are provided in Table 6-1.

| Modification to the LIAISON® Testosterone | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cleared Device (k122793) | Modification | Rationale |
| Name/Part Number | | |
| LIAISON® Testosterone<br>310410 | LIAISON® Testosterone xt<br>318410 | N/A |
| Assay Measuring Range | | |
| 0.16 - 15.0 ng/mL | Extend Assay Measuring Range: 0.024 – 15.0 ng/mL | The extended Assay Measuring Range and increased sensitivity is needed to satisfy current market needs. |
| Reagent Integral Storage and Stability | | |
| After opening and each use, the Reagent Integral should be sealed with the tape provided with the kit, placed in the kit box and returned to storage at 2-8°C. Undue exposure to light should be avoided. Open use is four weeks when properly stored. | Extend Open Use Stability of Reagent Integral up to <b>eight (8) weeks</b> after opening when properly stored. | The extended Open Use Stability of the Reagent Integral once opened is desired to satisfy all customer needs:<br>- small labs, with a low ratio of test per month;<br>- large labs with high number of tests per months. |
| Calibrator Storage and Stability | | |
| LIAISON® Testosterone calibrators are liquid and ready to use. After use, the calibrators should be re-capped, and returned to storage at 2-8°C. Open use is 4 weeks when properly stored. | Extend Open Use Stability of Calibrators up to <b>eight (8) weeks</b> after opening when properly stored. | The extended stability of the Calibrators once opened is desired to satisfy all customer needs:<br>- small labs, with a low ratio of test per month;<br>- large labs with high number of tests per months. |
| Calibration Curve Stability | | |
| Recalibration in triplicate is mandatory whenever at least one of the following conditions occurs:<br>- The previous calibration | Extend Calibration Curve Stability up to <b>four (4) weeks</b> . | The extended calibration stability is desired to satisfy all customer needs:<br>- small labs, with a low ratio of test per month; |

#### Table 6-1: Summary of the Modifications

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| was performed more than 7<br>days before. | - large labs with high number<br>of tests per months. |
|-------------------------------------------|-------------------------------------------------------|
|-------------------------------------------|-------------------------------------------------------|

# 6.8. COMPARISON TO PREDICATE DEVICE

The following table (Table 6-2) provides a summary of the similarities and differences between the predicate device, the LIAISON® Testosterone (k122793), and the modified device (k201908).

| Table 6-2: Comparison to Predicate Device |
|-------------------------------------------|
|-------------------------------------------|

| | Predicate Device | Modified Device |
|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | LIAISON® Testosterone<br>(k122793, cleared 01/25/2013) | LIAISON® Testosterone xt (k201908) |
| SIMILARITIES | | |
| | The LIAISON® Testosterone is a direct,<br>competitive,<br>chemiluminescence<br>immunoassay (CLIA) intended for the<br>quantitative determination of testosterone in<br>human serum and EDTA plasma on the<br>LIAISON® Analyzer. The assay is intended for<br><i>in vitro</i> diagnostic use. | The LIAISON® Testosterone xt is a direct,<br>competitive,<br>chemiluminescence<br>immunoassay (CLIA) intended for the<br>quantitative determination of testosterone in<br>human serum and EDTA plasma on the<br>LIAISON® XL Analyzer. The assay is<br>intended for <i>in vitro</i> diagnostic use. |
| Intended<br>Use/Indications<br>for Use | Measurement of testosterone is used in the<br>diagnosis and treatment of disorders involving<br>the male sex hormones (androgens),<br>including primary and secondary<br>hypogonadism, delayed or precocious<br>puberty, impotence in males and, in females<br>hirsutism (excessive hair) and virilization<br>(masculinization) due to tumors, polycystic<br>ovaries, and adrenogenital syndromes.<br>The test has to be performed on the<br>LIAISON® Analyzer Family*. | Measurement of testosterone is used in the<br>diagnosis and treatment of disorders<br>involving the male sex hormones<br>(androgens), including primary and<br>secondary hypogonadism, delayed or<br>precocious puberty, impotence in males and,<br>in females hirsutism (excessive hair) and<br>virilization (masculinization) due to tumors,<br>polycystic ovaries, and adrenogenital<br>syndromes.<br>The test has to be performed on the<br>LIAISON® XL Analyzer. |
| | *(LIAISON® and LIAISON® XL) | |
| Principle of the<br>Procedure | The LIAISON® Testosterone assay's method<br>for quantitative determination of testosterone<br>is a direct, competitive, chemiluminescence<br>immunoassay (CLIA). Specific antibody to<br>testosterone is bound to magnetic particles<br>(solid phase) and testosterone is linked to an<br>isoluminol derivative. During the incubation,<br>testosterone is dissociated from its binding<br>protein and competes with labeled<br>testosterone for binding sites on the antibody.<br>After the incubation, the unbound material is<br>removed with a wash cycle. Subsequently, the<br>starter reagents are added and a flash<br>chemiluminescent reaction is initiated. The<br>light signal is measured by a photomultiplier<br>as relative light units (RLU) and is inversely | Same |
| proportional to the concentration of<br>testosterone present in calibrators, controls,<br>or samples. | | |
| Technology/<br>Assay Principle | Chemiluminescent Immunoassay (CLIA) | Same |
| Sample<br>Handling/Assay<br>Processing | Automated | Same |
| Reagent<br>Integral<br>Configuration/<br>Formulation<br>(1 compartment<br>each reagent) | Magnetic Particles: Magnetic particles coated with mouse MAb against testosterone, phosphate buffer, BSA, goat immunoglobulin, and 0.2% Proclin® 300. Conjugate: Testosterone conjugated to an isoluminol derivative, in phosphate buffer with surfactant, BSA and <0.1% Sodium Azide. Assay Buffer: Phosphate buffer with surfactant, BSA, and <0.1% Sodium Azide. | Same |
| Reagent<br>Volume<br>Provided | Magnetic particles: 1 compartment (2.4 mL) Conjugate: 1 compartment (12 mL) Assay Buffer: 1 compartment (12 mL) | Same |
| Tests per Kit | 100 tests | Same |
| Raw materials | Antigen: Testosterone Detector: Testosterone conjugated to an isoluminol derivative. Capture: Magnetic particles coated with mouse MAb against testosterone. | Same |
| Calibrator 1 | Calibrator 1, low: containing hormone free human serum spiked with testosterone, 0.2% Proclin® 300. | Same |
| Calibrator 2 | Calibrator 2, high: containing hormone free human serum spiked with testosterone, 0.2% Proclin® 300. | Same |
| Calibrator<br>Configuration | 2 vials each level<br>2.0 mL/vial, ready to use. | Same |
| Storage of<br>Unopened<br>Reagents | Store at 2-8° C until ready to use | Same |
| Shelf Life | 12 months | Same |
| Measured<br>Analyte | Testosterone | Same |
| Sample Type | Human Serum and EDTA plasma | Same |
| Sample Volume | 100 uL | Same |
| Sample<br>Storage | If the assay is performed within 5 days of sample collection, the samples should be kept at 2-8°C; otherwise they should be stored frozen (-20°C or below) | Same |
| Assay<br>Procedure | 1. Dispense sample, calibrator or control into reaction module.<br>2. Dispense magnetic particle and assay buffer into reaction module.<br>3. Incubate<br>4. Dispense conjugate into reaction module.<br>5. Incubate<br>6. Wash with Wash/System liquid<br>7. Add the Starter Reagents and measure the light emitted. | Same |
| Total<br>Incubation | 13 minutes | Same |
| Measurement<br>System | Photomultiplier (flash chemiluminescence reader) | Same |
| Calibration | Two point verification of stored master curve | Same |
| Unit of Measure | ng/mL (ng/dL) | Same |
| Calibrators | Included with kit | Same |
| Controls | Provided Separately | Same |
| | DIFFERENCES | |
| Proprietary | LIAISON® Testosterone | LIAISON® Testosterone xt |
| Product Code | 310410 | 318410 |
| Instrument<br>Platform(s) | LIAISON® and LIAISON® XL Analyzer | LIAISON® XL Analyzer |
| Assay<br>Measuring | 0.16 to 15.0 ng/mL | 0.024 to 15.0 ng/mL |
| Limit of Blank<br>(LoB) | ≤ 0.031 ng/mL | ≤ 0.005 ng/mL |
| Limit of<br>Detection (LoD) | 0.098 ng/mL | 0.010 ng/mL |
| Limit of<br>Quantitation<br>(LoQ) | 0.160 ng/mL | 0.024 ng/mL |
| Method<br>Comparison | A Passing and Bablok regression analysis<br>yeilded an agreement of y = $0.9390x – 0.1002$<br>for the LIAISON® Testosterone assay versus<br>a commercially available immunoassay. The<br>95% confidence intervals for the slope are<br>0.92 to 0.96 and -1.88 to 1.80 ng/dL for the<br>intercept. | A Passing-Bablok regression analysis<br>yielded agreement of y = $0.99x – 1.77$ ng/dL<br>for the LIAISON® Testosterone xt versus the<br>CDC HoSt Testosterone RMP ID-LC-MS/MS<br>values. The 95% confidence intervals for the<br>slope are 0.97 to 1.02 and -3.22 to -0.35<br>ng/dL for the intercept. |
| Precision | Total/Across Lots (%CV): 7.9% – 14.0% | Total/Across Lots (%CV): 3.5% – 7.9 % |
| Linearity | The resulting equations for each sample type are:<br>• Serum: Observed Analyte = $0.9942x – 16.062$ ; $R^2 = 0.9959$<br>• SST Serum: Observed Analyte = $1.0188x - 14.531$ ; $R^2 = 0.9965$<br>• EDTA plasma: Observed Analyte = $1.0057x - 13.029$ ; $R^2 = 0.9913$ | The resulting equations for each sample type are:<br>• Serum: Observed Analyte = $0.995x + 0.0346$ ; $R^2 = 0.9928$<br>• SST Serum: Observed Analyte = $1.0225x - 57.853$ ; $R^2 = 0.9914$<br>• EDTA plasma: Observed Analyte = $1.0337x - 31.889$ ; $R^2 = 0.9955$ |
| Recovery | Mean Recovery (%): 97%<br>Range (%): 91% - 105% | Mean Recovery (%): 99%<br>Range (%): 93% - 105% |
| Open Use<br>Stability:<br>Reagent | Open use is four weeks when properly stored. | Open use is 8 weeks when properly stored. |
| Open Use<br>Stability:<br>Calibrators | Open use is 4 weeks when properly stored.…