(39 days)
Not Found
No
The summary describes a standard chemiluminescent immunoassay performed on an automated analyzer, with no mention of AI or ML in the device description, intended use, or performance studies. The analysis relies on a 2-point calibration and measurement of relative light units, which are not indicative of AI/ML technology.
No.
This device is an in vitro diagnostic immunoassay used for quantitative determination of TSH in human serum, which aids in the diagnosis of thyroid or pituitary disorders. It does not provide any treatment or therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states that "Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders." This indicates that the device aids in diagnosis.
No
The device is an in vitro diagnostic (IVD) immunoassay kit that requires a specific hardware analyzer (LIAISON® XL Analyzer) to perform the test and generate results. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the assay is "in vitro" and intended for the "quantitative determination of thyroid stimulating hormone (TSH)... in human serum." It also mentions its use in the "diagnosis of thyroid or pituitary disorders." This clearly aligns with the definition of an IVD, which are tests performed on samples taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description reiterates that it's an "in vitro chemiluminescent immunoassay" and details the process of analyzing human serum samples.
- Performance Studies: The document includes performance studies like Method Comparison, Reference Range/Expected Values, Reproducibility/Precision, Linearity, LoB/LoD/LoQ, and Interfering Substances. These are standard types of studies performed to validate the performance of IVD devices.
- Predicate Device(s): The mention of predicate devices (K961491 Roche Elecsys® TSH Assay and K090541 Elecsys® PreciControl Universal) further confirms its classification as an IVD, as predicate devices are used in the regulatory submission process for new IVDs.
All these elements strongly indicate that the DiaSorin LIAISON® TSH assay and its associated controls are intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The DiaSorin LIAISON® TSH assay is an in vitro chemiluminescent immunoassay for the quantitative determination of thyroid stimulating hormone (TSH), also known as thyrotropin and thyrotropic hormone, in human serum. The test has to be performed on the LIAISON® XL Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The DiaSorin LIAISON® Control Thyroid 1, LIAISON® Control Thyroid 2 and LIAISON® Control Thyroid 3 are intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® TSH assay.
Product codes (comma separated list FDA assigned to the subject device)
JLW, JJX
Device Description
The method for the quantitative determination of TSH is a sandwich chemiluminescence immunoassay. A specific mouse monoclonal antibody is coated on the magnetic particles (solid phase); another monoclonal antibody is linked to an isoluminol derivative (isoluminol-antibody conjugate). All assay steps and incubations are performed by the LIAISON® XL Analyzer.
Results are determined by a 2 point calibration conversion of the master curve to a working curve. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is inversely related to TSH concentration present in calibrators, patient samples or controls.
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
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison:
One hundred eighty-one (181) samples were tested by the LIAISON® TSH assay and a commercially available immunoassay. The method comparison study was performed according to CLSI EP9-A2 guideline. The samples ranged in concentration from 0.0257 to 89.56 mIU/L.
Results: Passing & Bablok regression analysis was performed on the results across the range of LIAISON® TSH assay yielding agreement of y = 1.005x-0.0030, R2 = 0.9748. The 95% confidence interval for slope is 0.988 to 1.026 and 95 % confidence interval for the intercept is -0.0873 to 0.0411 mIU/L.
Reference Range/Expected Values:
Human serum samples from 130 apparently healthy test subjects were tested to determine the reference range for the LIAISON® TSH assay.
Results: Median 1.438 mIU/L, Observed 95% Normal Range 0.357 – 4.789 mIU/L.
Reproducibility/Precision:
A twenty day precision study was performed at DiaSorin Inc. A coded panel comprised of 6 frozen serum samples was prepared. The coded panel contained 2 of each level of low, medium and high samples which span the measuring range of the assay. The LIAISON® Control Thyroid (3 levels) were also tested in the study. The CLSI document EP5-A2 was consulted in the preparation of the testing protocol. The precision panel samples and kit controls were tested on two lots of LIAISON® TSH assay in two replicates per run, 2 runs per day for 20 operating days for a total of 160 replicate results per sample.
The mean, standard deviation, and coefficient of variation (%CV) of the results were computed for each of the tested specimens.
Results: The 20 day results are summarized with overall mean TSH concentration, computed SDs and %CVs for within run and total across lots for KC 1, KC 2, KC 3, Sample 1, Sample 2, Sample 3, Sample 4, Sample 5, and Sample 6. %CVs ranged from 0.3% to 5.5%.
Linearity:
The linearity for LIAISON® TSH assay was determined, based on guidance from CLSI protocol EP6-A. A high TSH sample was serially diluted with LIAISON® Endocrinology Diluent to generate 7 concentrations across the range 0.0150 to 91.3 mIU/L.
Results: Passing & Bablok regression analysis was performed on the results yielding agreement of y = 0.9807x+0.0013, R2 = 0.9997. The linearity was measured on the LJAJSON® XL Analyzer and has been demonstrated to be linear from 0.02 mIU/L to 90 mIU/L.
LoB/LoD/LoQ:
The Limit of Blank, Limit of Detection and Limit of Quantitation were determined according to CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline June 2012- Second Edition. LoQ is defined as inter-assay precision of
§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.
0
K130469
1
5.0 510(k) SUMMARY
SUBMITTED BY:
Kelly R. Sauer Regulatory Affairs Specialist DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Phone (651) 351-5884 Fax (651) 351-5669 Email: kelly sauer@diasorin.com
NAME OF DEVICE:
Trade Name:
LIAISON® TSH LIAISON® Control Thyroid 1 LIAISON® Control Thyroid 2 LIAISON® Control Thyroid 3
Common Names/Descriptions:
Thyroid stimulating hormone
Classification Names:
Thyroid stimulating hormone test system: Class II 21 CFR 862.1690; Clinical Chemistry (75) Quality Control Material: Class I, reserved 21 CFR 862.1660; Clinical Chemistry (75)
Product Code:
PREDICATE DEVICE:
JLW, JJX
Roche Elecsys® TSH Assay Reference K961491 (Assay) Elecsys® PreciControl Universal Reference K090541 (Controls)
DEVICE DESCRIPTION:
INTENDED USE:
The DiaSorin LIAISON® TSH assay is an in vitro chemiluminescent immunoassay for the quantitative determination of thyroid stimulating hormone (TSH), also known as thyrotropin and thyrotropic hormone, in human serum. The test has to be performed on the LIAISON® XL Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The DiaSorin LIAISON® Control Thyroid 1, LIAISON® Control Thyroid 2 and LIAISON® Control Thyroid 3 are intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® TSH assay.
APR 0 5 2013
1
KIT DESCRIPTION:
The method for the quantitative determination of TSH is a sandwich chemiluminescence immunoassay. A specific mouse monoclonal antibody is coated on the magnetic particles (solid phase); another monoclonal antibody is linked to an isoluminol derivative (isoluminol-antibody conjugate). All assay steps and incubations are performed by the LIAISON® XL Analyzer.
Results are determined by a 2 point calibration conversion of the master curve to a working curve. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is inversely related to TSH concentration present in calibrators, patient samples or controls.
COMPARISON TO PREDICATE DEVICE:
The DiaSorin LIAISON TSH assay is substantially equivalent in principle and performance to the Roche Elecsys® TSH Test (K961491) which was FDA cleared July 22, 1996. The DiaSorin LIAISON® Control Thyroid 1, LIAISON® Control 2 and LIAISON® Control 3 are substantially equivalent in principle to the Roche Elecsys® PreciControl Universal (K090541).
| Characteristic | New Device
LIAISON® TSH | Predicate Device
Roche Elecsys® TSH (K961491) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The DiaSorin LIAISON® TSH
assay is a chemiluminescent
immunoassay (CLIA)
intended for the quantitative
determination of thyroid
stimulating hormone (TSH),
also known thyrotropin and
thyrotropic hormone in
human serum. The test must
be performed on the
LIAISON® XL Analyzer. | Immunoassay for the in vitro
quantitative determination of
thyrotropin in human serum and
plasma. The
electrochemiluminescence
Immunoassay "ECLIA" is intended for
use on Elecsys and cobas e
immunoassay analyzers. |
| Indications for Use | Measurements of TSH
produced by the anterior
pituitary are used in the
diagnosis of thyroid or
pituitary disorders. | Same |
| Measured Analyte | Thyroid stimulating hormone
also known as thyrotropin
and thyrotropic hormone | Same |
| Assay Type | Chemiluminescent
Immunoassay
Sandwich principle | Electrochemiluminescent
immunoassay
Sandwich principle |
| Calibration | Two-point verification of
stored master curve. | Same |
2
Table 1: Table of Assay Similarities and Differences
2
| Standarization | 2nd IRP WHO Reference
Standard 80/558 | Same |
|---------------------------------|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Reagent Integral
Storage | On-board or in refrigerator@
2-8°C | Same |
| Sample
Handling/Processing | Automated | Same |
| Conjugate Antibody | Mouse monoclonal anti-TSH | Same |
| Unit of Measure | mIU/L | µIU/mL or mIU/L (selectable) |
| Reference range | Serum - 0.357 - 4.789 mIU/L | Serum - 0.270 – 4.20 µIU/mL |
| Assay range · | Reportable Range :
0.02 to 90 mIU/L | Reportable Range :
0.010 – 100 μIU/mL |
| Sample Matrix | Human serum | Human serum and plasma |
| Sample size | 200 µL | 50 μL |
| Assay time to first
result | 17 minutes | 18 minutes |
| Open storage
2-8°C | 6 weeks | 12 weeks |
| Open storage
on analyzer | 6 weeks | Same |
| Calibration Stability | Calibration is required every
4 weeks | A calibration is required after 1 month
when using the same reagent lot,
after 7 days when using the same
reagent lot on the analyzer. |
| Calibrators | 2 levels - Included in integral | 2 levels - Not included with kit |
| Quality Controls
Recommended | 3 levels | 2 levels |
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3
| Characteristic | New Device
LIAISON® Control Thyroid 1
LIAISON® Control Thyroid 2
LIAISON® Control Thyroid 3 | Predicate Device
Elecsys® PreciControl
Universal (K090541) |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for use as assayed
quality control samples to
monitor the accuracy and
precision of the DiaSorin
LIAISON® TSH assay | Intended for use as quality
control of Elecsys®
immunoassays on the Elecsys®
and Cobas® e immunoassay
analyzers |
| Matrix | Human serum | Same |
| Reagent Format | Lyophilized | Same |
| Storage | Unopened store at 2-8° C until
expiration date | Same |
| Levels | Three concentrations :
Low, medium, high | Two concentrations :
Low and high |
| Reagent Format | 4 vials x 5.0 mL each level
Each level provided separately | 2 vials x 3.0 ml each level |
| Handling | Reconstitute with 5.0 mL
distilled water
and allow to stand 15 minutes
before use | Reconstitute with 3.0 mL
distilled water
and allow to stand 30 minutes
before use. |
| Open Storage | Reconstituted :
48 hours at 2-8° C
For longer storage periods,
frozen to -20 °C | Reconstituted :
On analyzer at 20-25° C up to 5
hrs ; 3 days at 2-8° C;
-20° C for up to 1 month |
PERFORMANCE DATA for the TSH Assay:
Method Comparison:
One hundred eighty-one (181) samples were tested by the LIAISON® TSH assay and a commercially available immunoassay. The method comparison study was performed according to CLSI EP9-A2 guideline. The samples ranged in concentration from 0.0257 to 89.56 mIU/L.
Results:
Passing & Bablok regression analysis was performed on the results across the range of LIAISON® TSH assay yielding agreement of y = 1.005x-0.0030, R2 = 0.9748. The 95% confidence interval for slope is 0.988 to 1.026 and 95 % confidence interval for the intercept is -0.0873 to 0.0411 mIU/L.
র্ব
4
Reference Range/Expected Values:
Human serum samples from 130 apparently healthy test subjects were tested to determine the reference range for the LIAISON® TSH assay.
| Apparently Healthy Test Subjects | Median | Observed 95% Normal Range |
|---|---|---|
| Serum (130) | 1.438 mIU/L | 0.357 – 4.789 mIU/L |
| Consider these limits as guidelines only. Each laboratory should establish its own reference range |
Reproducibility/Precision:
A twenty day precision study was performed at DiaSorin Inc.. A coded panel comprised of 6 frozen serum samples was prepared. The coded panel contained 2 of each level of low, medium and high samples which span the measuring range of the assay. The LIAISON® Control Thyroid (3 levels) were also tested in the study. The CLSI document EP5-A2 was consulted in the preparation of the testing protocol.
The precision panel samples and kit controls were tested on two lots of LIAISON® TSH assay in two replicates per run, 2 runs per day for 20 operating days for a total of 160 replicate results per sample.
The mean, standard deviation, and coefficient of variation (%CV) of the results were computed for each of the tested specimens.
Results:
The 20 day results are summarized in Table 1 as sample overall mean TSH concentration in mIU/L, computed SDs and %CVs for within run and total across lots.
| Sample ID | N | Mean
mIU/L | Between
Lot / Within-
Site | | Total
Across Lots /
Within Sites | |
|-----------|-----|---------------|----------------------------------|------|----------------------------------------|------|
| | | | SD | %CV | SD | %CV |
| KC 1 | 160 | 0.6401 | 0.03 | 4.1% | 0.03 | 4.3% |
| KC 2 | 160 | 8.140 | 0.19 | 2.4% | 0.39 | 4.8% |
| KC 3 | 160 | 47.61 | 0.24 | 0.5% | 2.55 | 5.4% |
| Sample 1 | 160 | 0.2660 | 0.01 | 3.6% | 0.01 | 5.5% |
| Sample 2 | 160 | 1.201 | 0.03 | 2.3% | 0.05 | 3.8% |
| Sample 3 | 160 | 4.702 | 0.07 | 1.4% | 0.20 | 4.3% |
| Sample 4 | 160 | 28.47 | 0.35 | 1.2% | 1.01 | 3.6% |
| Sample 5 | 160 | 46.19 | 0.25 | 0.5% | 1.80 | 3.9% |
| Sample 6 | 160 | 82.56 | 0.21 | 0.3% | 3.47 | 4.2% |
5
Linearity:
The linearity for LIAISON® TSH assay was determined, based on guidance from CLSI protocol EP6-A. A high TSH sample was serially diluted with LIAISON® Endocrinology Diluent to generate 7 concentrations across the range 0.0150 to 91.3 mIU/L.
Results:
Passing & Bablok regression analysis was performed on the results yielding agreement of y = 0.9807x+0.0013, R2 = 0.9997. The linearity was measured on the LJAJSON® XL Analyzer and has been demonstrated to be linear from 0.02 mIU/L to 90 mIU/L.
LoB/LoD/LoQ:
The Limit of Blank, Limit of Detection and Limit of Quantitation were determined according to CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline June 2012- Second Edition.
LoQ is defined as inter-assay precision of