(135 days)
No
The device description and performance studies focus on a standard chemiluminescence immunoassay (CLIA) method and do not mention any AI or ML components. The analysis is based on a direct chemical reaction and light measurement.
No
The device is an in vitro diagnostic (IVD) assay designed for quantitative determination of testosterone levels, which is used for diagnosis and monitoring of disorders, not for direct treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the assay is "intended for in vitro diagnostic use" and that "Measurement of testosterone is used in the diagnosis and treatment of disorders".
No
The device description clearly outlines a physical reagent kit and its use with a physical analyzer (LIAISON® Analyzer) to perform a chemiluminescence immunoassay. This involves physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in the "Intended Use / Indications for Use" section: "The assay is intended for in vitro diagnostic use."
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
CDZ, JJX
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.
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
Males 18-49 years
Males >= 50 years
Females 18-49 years
Females >= 50 years
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 LIASORIN® 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: = 50 years 132 4.53 (453) 1.95 - 8.95 (195 – 895)
Females 18-49 years 202 0.24 (24.0) = 50 years 127 0.22 (22.0)
§ 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.
0
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.
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.
1
·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:
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.
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 vitro
quantitative determination of
testosterone in human serum
and EDTA plasma. | Intended for the in vitro
quantitative determination of
testosterone in human serum
and plasma. |
| Indications for
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 | 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,
impotence in males and, in
females hirsutism (excessive
hair) and virilization
(masculinization) due to |
DiaSorin LIAISON® Testosterone Similarities and Differences
2
| | tumors, polycystic ovaries, and
adrenogenital syndromes. | tumors, polycystic ovaries, and
androgenital syndromes. |
|-----------------------------|-------------------------------------------------------------|-------------------------------------------------------------|
| Assay Type | Chemiluminescent
Immunoassay | Electrochemiluminescence
Immunoassay "ECLIA" |
| Analyte | Testosterone | Testosterone |
| Calibration | Two-point verification of stored
master 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 (flash
chemiluminescence reader) | Photomultiplier (flash
chemiluminescence reader) |
| Calibrators | Included with kit | Provided separately |
| Capture Antibody | Mouse monoclonal antibodies
to testosterone | Biotinylated sheep monoclonal
antibodies 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 on
analyzer | NA | 8 weeks |
DiaSorin LIAISON® Testosterone Control Set Similarities and Differences
| Characteristic | LIAISON® Testosterone
Control Set | Roche PreciControl Universal
1 and 2 (K090541) |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for use as assay
quality control samples to
monitor the accuracy and
precision of the DiaSorin
LIAISON® Testosterone
immunoassay. | Intended for use as quality
control of Elecsys®
immunoassays on the Elecsys®
and Cobas® immunoassay
analyzers® |
| Matrix | Human serum | Same |
| Levels | Two concentrations :
low and high | Same |
| Reagent Format | Liquid
2 vials x 3.5 mL each level | Lyophilized
2 vials x 3.0 ml each level |
| Handling | Ready to use | Reconstitute with distilled water
and allow 30 minutes for
reconstitution. |
| Storage @ 2-8° C | Unopened store at 2-8° C until
expiration date | Same |
·
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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 Testosterone
Conc. ng/mL (ng/dL) | Central 95% Interval
ng/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) | 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
5
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 |