K Number
K201908
Device Name
LIAISON Testosterone xt
Manufacturer
Date Cleared
2020-10-15

(98 days)

Product Code
Regulation Number
862.1680
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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. 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. 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. 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.
More Information

No
The description details a standard chemiluminescence immunoassay (CLIA) and the associated automated analyzer. There is no mention of AI or ML in the intended use, device description, or performance metrics. The technology described is based on chemical reactions and light measurement, not data-driven algorithms.

No.
This device is an in vitro diagnostic (IVD) device used for the quantitative determination of testosterone in human samples to aid in the diagnosis and treatment of disorders. It does not directly treat or prevent a disease or condition in a patient.

Yes

The "Intended Use / Indications for Use" section explicitly states, "The assay is intended for in vitro diagnostic use." It also mentions that the measurement of testosterone is "used in the diagnosis and treatment of disorders."

No

The device is an in vitro diagnostic assay consisting of reagents and is performed on a specific hardware analyzer (LIAISON® XL Analyzer). It is not solely software.

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states: "The assay is intended for in vitro diagnostic use."

N/A

Intended Use / Indications for Use

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.

Product codes

CDZ

Device Description

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.

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. 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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use (Part 21 CFR 801 Subpart D)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

The document refers to Table 6-2 for the summary results of the verification and validation testing, which describes the "Comparison to Predicate Device" for the modified device (LIAISON® Testosterone xt) against the predicate device (LIAISON® Testosterone).

Study Type: Verification and validation testing.

Key results from Table 6-2:

  • Assay Measuring Range: Extended from 0.16 – 15.0 ng/mL (predicate) to 0.024 – 15.0 ng/mL (modified).
  • Limit of Blank (LoB): Modified device ≤ 0.005 ng/mL, predicate ≤ 0.031 ng/mL.
  • Limit of Detection (LoD): Modified device 0.010 ng/mL, predicate 0.098 ng/mL.
  • Limit of Quantitation (LoQ): Modified device 0.024 ng/mL, predicate 0.160 ng/mL.
  • Method Comparison:
    • Predicate Device: A Passing and Bablok regression analysis yielded an agreement of y = 0.9390x – 0.1002 for the LIAISON® Testosterone assay versus a commercially available immunoassay. The 95% confidence intervals for the slope are 0.92 to 0.96 and -1.88 to 1.80 ng/dL for the intercept.
    • Modified Device: A Passing-Bablok regression analysis yielded agreement of y = 0.99x – 1.77 ng/dL for the LIAISON® Testosterone xt versus the CDC HoSt Testosterone RMP ID-LC-MS/MS values. The 95% confidence intervals for the slope are 0.97 to 1.02 and -3.22 to -0.35 ng/dL for the intercept.
  • Precision:
    • Predicate Device: Total/Across Lots (%CV): 7.9% – 14.0%.
    • Modified Device: Total/Across Lots (%CV): 3.5% – 7.9 %.
  • Linearity:
    • Predicate Device:
      • Serum: Observed Analyte = 0.9942x – 16.062 ; R^2 = 0.9959
      • SST Serum: Observed Analyte = 1.0188x - 14.531 ; R^2 = 0.9965
      • EDTA plasma: Observed Analyte = 1.0057x - 13.029 ; R^2 = 0.9913
    • Modified Device:
      • Serum: Observed Analyte = 0.995x + 0.0346 ; R^2 = 0.9928
      • SST Serum: Observed Analyte = 1.0225x - 57.853 ; R^2 = 0.9914
      • EDTA plasma: Observed Analyte = 1.0337x - 31.889 ; R^2 = 0.9955
  • Recovery:
    • Predicate Device: Mean Recovery (%): 97%, Range (%): 91% - 105%.
    • Modified Device: Mean Recovery (%): 99%, Range (%): 93% - 105%.
  • Open Use Stability (Reagent):
    • Predicate Device: Four weeks when properly stored.
    • Modified Device: 8 weeks when properly stored.
  • Open Use Stability (Calibrators):
    • Predicate Device: 4 weeks when properly stored.
    • Modified Device: 8 weeks when stored at 2-8°C.
  • Calibration Curve Stability:
    • Predicate Device: 7 days.
    • Modified Device: 28 days.

Key Metrics

  • Assay Measuring Range: Extended from 0.16 – 15.0 ng/mL to 0.024 – 15.0 ng/mL.
  • Limit of Blank (LoB): Modified device ≤ 0.005 ng/mL, predicate ≤ 0.031 ng/mL.
  • Limit of Detection (LoD): Modified device 0.010 ng/mL, predicate 0.098 ng/mL.
  • Limit of Quantitation (LoQ): Modified device 0.024 ng/mL, predicate 0.160 ng/mL.
  • Precision (Total/Across Lots %CV): Modified device 3.5% – 7.9 %, predicate 7.9% – 14.0%.
  • Mean Recovery (%): Modified device 99%, predicate 97%.
  • Recovery Range (%): Modified device 93% - 105%, predicate 91% - 105%.

Predicate Device(s)

LIAISON® Testosterone (K122793)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.
1951 Northwestern Avenue
P.O. Box 285
Stillwater, MN 55082-0285 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mari Meyer
Vice President, Regulatory and Clinical Affairs
Email: mari.meyer@diasorin.com
Phone: (715) 410-7149
Fax:
(651) 351-5669 |
| 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
Section | Product
Code | Device
Class | Classification
Panel |
|------------------------------------------|---------------------------------------------------------------|-----------------------|-----------------|----------------------|-------------------------------|
| LIAISON®
Testosterone xt
(K201908) | Radioimmunoassay,
Testosterones And
Dihydrotestosterone | 862.1680 | CDZ | Class I,
Reserved | Clinical
Chemistry
(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)ModificationRationale
Name/Part Number
LIAISON® Testosterone
310410LIAISON® Testosterone xt
318410N/A
Assay Measuring Range
0.16 - 15.0 ng/mLExtend Assay Measuring Range: 0.024 – 15.0 ng/mLThe 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 eight (8) weeks after opening when properly stored.The extended Open Use Stability of the Reagent Integral once opened is desired to satisfy all customer needs:
  • small labs, with a low ratio of test per month;
  • 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 eight (8) weeks after opening when properly stored. | The extended stability of the Calibrators once opened is desired to satisfy all customer needs:
  • small labs, with a low ratio of test per month;
  • 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:
  • The previous calibration | Extend Calibration Curve Stability up to four (4) weeks . | The extended calibration stability is desired to satisfy all customer needs:
  • 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
days before. | - large labs with high number
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 DeviceModified Device
CharacteristicLIAISON® Testosterone
(K122793, cleared 01/25/2013)LIAISON® Testosterone xt (K201908)
SIMILARITIES
The LIAISON® Testosterone is a direct,
competitive,
chemiluminescence
immunoassay (CLIA) intended for the
quantitative determination of testosterone in
human serum and EDTA plasma on the
LIAISON® Analyzer. The assay is intended for
in vitro diagnostic use.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.
Intended
Use/Indications
for UseMeasurement 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® Analyzer Family*.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.
*(LIAISON® and LIAISON® XL)
Principle of the
ProcedureThe 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 inverselySame
proportional to the concentration of
testosterone present in calibrators, controls,
or samples.
Technology/
Assay PrincipleChemiluminescent Immunoassay (CLIA)Same
Sample
Handling/Assay
ProcessingAutomatedSame
Reagent
Integral
Configuration/
Formulation
(1 compartment
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