(98 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the LIAISON® Testosterone xt device, extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (LIAISON® Testosterone xt) |
|---|---|---|
| Assay Measuring Range | 0.16 - 15.0 ng/mL | Extended: 0.024 – 15.0 ng/mL |
| Limit of Blank (LoB) | ≤ 0.031 ng/mL | Improved: ≤ 0.005 ng/mL |
| Limit of Detection (LoD) | 0.098 ng/mL | Improved: 0.010 ng/mL |
| Limit of Quantitation (LoQ) | 0.160 ng/mL | Improved: 0.024 ng/mL |
| Method Comparison | y = 0.9390x – 0.1002 (vs. commercially available immunoassay) 95% CI for slope: 0.92 to 0.96 95% CI for intercept: -1.88 to 1.80 ng/dL | y = 0.99x – 1.77 ng/dL (vs. CDC HoSt Testosterone RMP ID-LC-MS/MS values) 95% CI for slope: 0.97 to 1.02 95% CI for intercept: -3.22 to -0.35 ng/dL |
| Precision (Total/Across Lots %CV) | 7.9% – 14.0% | Improved: 3.5% – 7.9 % |
| Linearity (Serum) | Observed Analyte = 0.9942x – 16.062; R² = 0.9959 | Observed Analyte = 0.995x + 0.0346; R² = 0.9928 |
| Linearity (SST Serum) | Observed Analyte = 1.0188x - 14.531; R² = 0.9965 | Observed Analyte = 1.0225x - 57.853; R² = 0.9914 |
| Linearity (EDTA plasma) | Observed Analyte = 1.0057x - 13.029; R² = 0.9913 | Observed Analyte = 1.0337x - 31.889; R² = 0.9955 |
| Recovery (Mean %) | 97% | 99% |
| Recovery (Range %) | 91% - 105% | 93% - 105% |
| Open Use Stability: Reagent Integral | 4 weeks | Extended: 8 weeks |
| Open Use Stability: Calibrators | 4 weeks | Extended: 8 weeks |
| Calibration Curve Stability | 7 days | Extended: 28 days |
2. Sample Size for the Test Set and Data Provenance
The provided document does not explicitly state the sample sizes used for each specific test (e.g., method comparison, precision, linearity, recovery). It only summarizes the results in "Table 6-2: Comparison to Predicate Device" and refers to "verification and validation activities" without detailing the exact number of samples for each.
The data provenance is not specified in terms of country of origin. The studies appear to be retrospective analyses of device performance characteristics, as they involve testing the LIAISON® Testosterone xt against existing methods or conditions to demonstrate equivalence and improved performance over the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not explicitly provided in the document. For the "Method Comparison," it refers to "commercially available immunoassay" and "CDC HoSt Testosterone RMP ID-LC-MS/MS values." The latter, CDC HoSt Testosterone RMP ID-LC-MS/MS, likely represents a highly accurate and standardized reference method, which serves as a widely accepted ground truth in laboratory medicine, rather than relying on individual expert consensus for each measurement. No human experts are mentioned for ground truth establishment.
4. Adjudication Method for the Test Set
No explicit adjudication method is mentioned. The studies focus on direct quantitative analytical performance comparisons rather than subjective human interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The LIAISON® Testosterone xt is an in vitro diagnostic device, specifically a chemiluminescence immunoassay (CLIA), for the quantitative determination of testosterone. It is an automated laboratory test, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, this is effectively a standalone device performance study. The LIAISON® Testosterone xt is an automated system where the measurement of testosterone is performed by the analyzer (LIAISON® XL Analyzer) without human intervention in the analytical process itself. The performance metrics (LoB, LoD, LoQ, precision, linearity, recovery) are all measures of the algorithm's and instrument's direct analytical capability.
7. The Type of Ground Truth Used
The ground truth used for method comparison was:
- For the predicate device: A "commercially available immunoassay."
- For the LIAISON® Testosterone xt: "CDC HoSt Testosterone RMP ID-LC-MS/MS values." This is a highly accurate, reference method-based measurement, representing the gold standard for testosterone quantification. Other ground truths were established by controlled experiments for limits (e.g., dilution series for LoB, LoD, LoQ), spiked samples for recovery, and replicated measurements for precision.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is an immunoassay, not an AI model that requires a distinct training phase with a labeled dataset in the typical sense. Its development would involve analytical validation using various samples to optimize reagent formulation, assay parameters, and calibration, but not as a machine learning training set.
9. How the Ground Truth for the Training Set was Established
As explained above, there is no "training set" in the machine learning sense for this immunoassay. The development and validation of an immunoassay involve:
- Reference materials: Use of certified reference materials or reference methods (like ID-LC-MS/MS) to establish accurate values for calibrators and controls.
- Spiked samples: Samples with known concentrations of testosterone added.
- Clinical samples: Testing a range of patient samples representing the intended use population, comparing results to established methods.
- Statistical analysis: Extensive statistical methods are used during development and validation to ensure accuracy, precision, linearity, and other performance characteristics.
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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 AvenueP.O. Box 285Stillwater, MN 55082-0285 |
|---|---|
| Contact: | Mari MeyerVice President, Regulatory and Clinical AffairsEmail: mari.meyer@diasorin.comPhone: (715) 410-7149Fax:(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 | RegulationSection | ProductCode | DeviceClass | ClassificationPanel |
|---|---|---|---|---|---|
| LIAISON®Testosterone xt(K201908) | Radioimmunoassay,Testosterones AndDihydrotestosterone | 862.1680 | CDZ | Class I,Reserved | ClinicalChemistry(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® Testosterone310410 | LIAISON® Testosterone xt318410 | 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 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 7days before. | - large labs with high numberof 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(K122793, cleared 01/25/2013) | LIAISON® Testosterone xt (K201908) |
| SIMILARITIES | ||
| The LIAISON® Testosterone is a direct,competitive,chemiluminescenceimmunoassay (CLIA) intended for thequantitative determination of testosterone inhuman serum and EDTA plasma on theLIAISON® Analyzer. The assay is intended forin vitro diagnostic use. | The LIAISON® Testosterone xt is a direct,competitive,chemiluminescenceimmunoassay (CLIA) intended for thequantitative determination of testosterone inhuman serum and EDTA plasma on theLIAISON® XL Analyzer. The assay isintended for in vitro diagnostic use. | |
| IntendedUse/Indicationsfor Use | Measurement of testosterone is used in thediagnosis and treatment of disorders involvingthe male sex hormones (androgens),including primary and secondaryhypogonadism, delayed or precociouspuberty, impotence in males and, in femaleshirsutism (excessive hair) and virilization(masculinization) due to tumors, polycysticovaries, and adrenogenital syndromes.The test has to be performed on theLIAISON® Analyzer Family*. | Measurement of testosterone is used in thediagnosis and treatment of disordersinvolving the male sex hormones(androgens), including primary andsecondary hypogonadism, delayed orprecocious puberty, impotence in males and,in females hirsutism (excessive hair) andvirilization (masculinization) due to tumors,polycystic ovaries, and adrenogenitalsyndromes.The test has to be performed on theLIAISON® XL Analyzer. |
| *(LIAISON® and LIAISON® XL) | ||
| Principle of theProcedure | The LIAISON® Testosterone assay's methodfor quantitative determination of testosteroneis a direct, competitive, chemiluminescenceimmunoassay (CLIA). Specific antibody totestosterone is bound to magnetic particles(solid phase) and testosterone is linked to anisoluminol derivative. During the incubation,testosterone is dissociated from its bindingprotein and competes with labeledtestosterone for binding sites on the antibody.After the incubation, the unbound material isremoved with a wash cycle. Subsequently, thestarter reagents are added and a flashchemiluminescent reaction is initiated. Thelight signal is measured by a photomultiplieras relative light units (RLU) and is inversely | Same |
| proportional to the concentration oftestosterone present in calibrators, controls,or samples. | ||
| Technology/Assay Principle | Chemiluminescent Immunoassay (CLIA) | Same |
| SampleHandling/AssayProcessing | Automated | Same |
| ReagentIntegralConfiguration/Formulation(1 compartmenteach 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 |
| ReagentVolumeProvided | 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 |
| CalibratorConfiguration | 2 vials each level2.0 mL/vial, ready to use. | Same |
| Storage ofUnopenedReagents | Store at 2-8° C until ready to use | Same |
| Shelf Life | 12 months | Same |
| MeasuredAnalyte | Testosterone | Same |
| Sample Type | Human Serum and EDTA plasma | Same |
| Sample Volume | 100 uL | Same |
| SampleStorage | 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 |
| AssayProcedure | 1. Dispense sample, calibrator or control into reaction module.2. Dispense magnetic particle and assay buffer into reaction module.3. Incubate4. Dispense conjugate into reaction module.5. Incubate6. Wash with Wash/System liquid7. Add the Starter Reagents and measure the light emitted. | Same |
| TotalIncubation | 13 minutes | Same |
| MeasurementSystem | 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 |
| InstrumentPlatform(s) | LIAISON® and LIAISON® XL Analyzer | LIAISON® XL Analyzer |
| AssayMeasuring | 0.16 to 15.0 ng/mL | 0.024 to 15.0 ng/mL |
| Limit of Blank(LoB) | ≤ 0.031 ng/mL | ≤ 0.005 ng/mL |
| Limit ofDetection (LoD) | 0.098 ng/mL | 0.010 ng/mL |
| Limit ofQuantitation(LoQ) | 0.160 ng/mL | 0.024 ng/mL |
| MethodComparison | A Passing and Bablok regression analysisyeilded an agreement of y = $0.9390x – 0.1002$for the LIAISON® Testosterone assay versusa commercially available immunoassay. The95% confidence intervals for the slope are0.92 to 0.96 and -1.88 to 1.80 ng/dL for theintercept. | A Passing-Bablok regression analysisyielded agreement of y = $0.99x – 1.77$ ng/dLfor the LIAISON® Testosterone xt versus theCDC HoSt Testosterone RMP ID-LC-MS/MSvalues. The 95% confidence intervals for theslope are 0.97 to 1.02 and -3.22 to -0.35ng/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:• 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 = $1.0057x - 13.029$ ; $R^2 = 0.9913$ | The resulting equations for each sample type are:• 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 | Mean Recovery (%): 97%Range (%): 91% - 105% | Mean Recovery (%): 99%Range (%): 93% - 105% |
| Open UseStability:Reagent | Open use is four weeks when properly stored. | Open use is 8 weeks when properly stored. |
| Open UseStability:Calibrators | Open use is 4 weeks when properly stored. | Open use is 8 weeks when stored at 2-8°C. |
| CalibrationCurve Stability | 7 days | 28 days |
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DiaSorin
6.9. RISK MANAGEMENT
The Risk Management was performed in compliance with EN ISO 14971:2012 Medical Devices – Application of Risk Management to Medical Devices. The Failure Modes Effects Analysis (FMEA) methodology was used to systematically identify, estimate, evaluate, control and report risks to ensure the development and maintenance of a safe and effective product that meets its intended use.
6.10. VERIFICATION AND VALIDATION SUMMARY
All verification and validation activities were performed in accordance to relevant standards, established plans, protocols, and Design Control procedures. Testing verified all acceptance criteria were met. Verification of the changes did not raise any new items of safety and effectiveness.
6.11. SUMMARY OF PERFORMANCE DATA
Refer to Table 6-2: Comparison to Predicate Device for the summary results of the verification and validation testing.
6.12. SUBSTANTIAL EQUIVALENCE STATEMENT
All verification and validation testing conducted with the LIAISON® Testosterone xt assay demonstrate that the modified device met the predetermined acceptance criteria, supporting the determination of substantial equivalence to the predicate device.
The modifications to the predicate device to provide improved sensitivity do not substantially change the device. The validation and verification data demonstrate that the performance of the LIAISON® Testosterone xt to detect testosterone is substantially equivalent to the predicate device.
6.13. CONCLUSION
The material submitted in this Special 510(k): Device Modifications of the LIAISON® Testosterone (K122793) is complete and supports a substantial equivalence decision. The labeling satisfies the requirements of 21 CFR 809.10.
§ 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.