(126 days)
cobas e 801 immunoassay analyzer is intended for the in-vitro determination of analytes in body fluids.
Elecsys TSH immunoasay is intended for the in vitro quantitative determination of thyrotropin in human serum and plasma. Measurements of TSH are used in the diagnosis of thyroid or pituitary disorders. The Elecsys TSH immunoassay is an electrochemiluminescence immunoasay 'ECLIA', which is intended for use on the cobas e immunoassay analyzers.
The cobas e 801 immunoassay analyzer is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series cleared under K100853. It uses electrochemiluminescent technology for signal generation and measurement.
Here's a breakdown of the acceptance criteria and study information for the Elecsys TSH assay on the Cobas e 801 immunoassay Analyzer, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for each performance characteristic as pass/fail thresholds. Instead, it presents the results of various validation studies. I will present the reported performance, and where applicable, infer the implied acceptance based on the presentation of the results as successful.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Repeatability (CV%) | Low CV values, generally < 10% for low concentrations and < 5% for higher concentrations (common for immunoassays) | Human serum 1 (0.00851 µIU/mL): 7.1%Human serum 2 (0.209 µIU/mL): 1.6%Human serum 3 (1.88 µIU/mL): 1.4%Human serum 4 (51.8 µIU/mL): 1.3%Human serum 5 (90.0 µIU/mL): 1.4%PC Universal 1 (1.41 µIU/mL): 1.4%PC Universal 2 (8.18 µIU/mL): 1.6%PreciControl TS (0.184 µIU/mL): 1.8% |
| Intermediate Precision (CV%) | Low CV values, generally < 15% for low concentrations and < 10% for higher concentrations | Human serum 1 (0.00851 µIU/mL): 11.3%Human serum 2 (0.209 µIU/mL): 2.5%Human serum 3 (1.88 µIU/mL): 2.3%Human serum 4 (51.8 µIU/mL): 2.0%Human serum 5 (90.0 µIU/mL): 1.9%PC Universal 1 (1.41 µIU/mL): 2.1%PC Universal 2 (8.18 µIU/mL): 2.5%PreciControl TS (0.184 µIU/mL): 2.3% |
| Linearity (Pearson's r) | High correlation (e.g., > 0.99) and slope close to 1, intercept close to 0 across the measuring range | Serum 1: Pearson's r = 0.9994, slope = 0.963, intercept = -0.00155Serum 2: Pearson's r = 0.9992, slope = 0.958, intercept = -0.00193Serum 3: Pearson's r = 0.9986, slope = 0.952, intercept = -0.00272 |
| Limit of Blank (LoB) | Low value, typically indicative of assay's ability to distinguish analyte-free samples from those with very low levels. | 0.0025 µIU/mL |
| Limit of Detection (LoD) | Low value, indicating sensitivity to low analyte concentrations. Specific 95% probability is a common criterion. | 0.005 µIU/mL (detected with 95% probability) |
| Limit of Quantitation (LoQ) | Low value with acceptable precision (e.g., CV ≤ 20%) | 0.005 µIU/mL at a CV ≤ 20% |
| Endogenous Interferences | No significant interference at specified levels | No interference observed up to the indicated levels for Intralipid (2000 mg/dL), Biotin (56.0 ng/mL), Bilirubin (66.0 mg/dL), Hemoglobin (1000 mg/dL), Rheumatic Factor (1500 IU/mL), human IgG (2.80 g/dL), human IgM (0.500 g/dL). |
| Exogenous Interferences (Anticoagulants) | Values obtained from different sample types (serum, plasma with various anticoagulants) should be comparable. | Data supported the use of Serum, Li-Heparin, K2-EDTA, and K3-EDTA plasma tubes, evaluated using Passing/Bablok regression analysis comparing serum/plasma pairs. |
| Exogenous Interferences (Drugs) | No significant interference at specified drug concentrations | No interference found with 16 commonly used drugs and several special drugs (Amiodarone, Carbimazole, Fluocortolone, Hydrocortisone, Iodide, Levotyroxine, Liothyronine, Methimazole, Octreotide, Prednisolone, Propanolol, Propylthiouracil, Perchlorate) at tested concentrations. |
| Method Comparison (Correlation) | Strong correlation (e.g., Pearson's r > 0.98) and agreement (slope close to 1, intercept close to 0) with predicate device | N = 130 samplesPassing/Bablok: Slope = 0.936, Intercept = -0.003, Kendall ($\tau$) = 0.989Linear Regression: Slope = 0.958, Intercept = -0.052, Pearson (r) = 0.999 |
2. Sample Size and Data Provenance for Test Set
- Repeatability and Intermediate Precision:
- Sample Size:
- 7 human serum samples (5 pooled, 5 pooled spiked) and 2 control samples (PC Universal, PreciControl TS).
- Each sample tested in 2 replicates per run, 2 runs per day for 21 days (total of 84 replicate measurements per sample type).
- Sample Size:
- Linearity:
- Sample Size: 3 high analyte serum samples diluted to 12 concentrations. Each concentration assayed in 3-fold determination within a single run.
- Analytical Sensitivity (LoB, LoD, LoQ):
- LoB: Blank sample tested with 60 replicates (10 replicates per run, 6 days).
- LoD: 5 low-level human serum samples tested with 60 replicates (2 replicates per sample per run, 6 days).
- LoQ: 10 low-level TSH samples tested over 5 days, 5 replicates per sample per day.
- Endogenous Interferences:
- Human serum samples. Specific number not provided, but the outcome is qualitative ("No interference observed").
- Exogenous Interferences (Anticoagulants):
- A minimum of 40 serum/plasma pairs per sample material (presumably 40 serum, 40 Li-Heparin plasma, 40 K2-EDTA plasma, 40 K3-EDTA plasma). Tested in singleton for each type.
- Exogenous Interferences (Drugs):
- 16 commonly used drugs and 13 special drugs. Specific number of samples not provided, but the outcome is qualitative ("No interference").
- Method Comparison:
- Sample Size: 130 human serum samples (single donors and serum pools; native, spiked as well as diluted).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the use of "human serum samples" and "human serum/plasma pairs" indicates biological samples. The studies are prospective in nature, conducted specifically to validate the device.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
This device is an immunoassay for quantitative determination of TSH. The "ground truth" for the test set is established by the reference measurement method or the quantitative value itself. No human experts are used to establish ground truth in the same way they would be for image interpretation. The accuracy of the quantitative measurements is assessed against known concentrations (e.g., in linearity, LoB/LoD studies) or against a predicate device (method comparison).
4. Adjudication Method
Not applicable for an immunoassay. Adjudication is typically used when human interpretation of results contributes to the ground truth, which is not the case here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is relevant for diagnostic imaging or other interpretations where human readers are involved. This document describes the performance of an in-vitro diagnostic device (IVD) for quantitative measurement, which operates without direct human interpretive input being part of the core measurement.
6. Standalone Performance
Yes, these studies describe the standalone (algorithm only, in this context meaning the device's automated performance without human intervention after sample loading) performance of the Elecsys TSH assay on the cobas e 801 immunoassay analyzer. The results presented are directly from the instrument's measurements.
7. Type of Ground Truth Used
- Reference Materials/Known Concentrations: For precision, linearity, LoB, LoD, LoQ, endogenous and exogenous interference studies, ground truth implicitly refers to the expected concentration/value based on the preparation of known samples or the absence of an analyte (for blanks).
- Predicate Device Measurements: For the method comparison study, the "ground truth" for comparison is the measurement obtained from the predicate device (Elecsys TSH on Elecsys 2010 analyzer).
- Expected Values: The "Expected Values" section establishes a reference range (0.27-4.20 µIU/mL) based on healthy test subjects. This is a clinical reference range, not a direct ground truth for individual measurements, but rather a benchmark for interpretation.
8. Sample Size for the Training Set
The document describes validation studies for an in vitro diagnostic device (IVD), specifically an immunoassay analyzer and assay. IVDs like this do not typically have a "training set" in the machine learning sense. The device's operational parameters, calibration curves, and algorithms are developed during the product development phase by the manufacturer, which might involve internal data, but generally, the submission focuses on external validation. The document does not provide details on the development data used.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" described in the context of machine learning, this question about establishing ground truth for it is not applicable here. The device output is a quantitative value based on chemical reactions and detection, not a learned prediction from a ground-truthed dataset in the AI sense.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2017
ROCHE DIAGNOSTICS ANGELO PEREIRA REGULATORY AFFAIRS SENIOR PROGRAM MANAGER 9115 HAGUE ROAD INDIANAPOLIS, IN 46250 US
Re: K162606
Trade/Device Name: Elecsys TSH assay, Cobas e 801 immunoassay Analyzer Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: Class II Product Code: JWL, JJE Dated: December 20, 2016 Received: December 21, 2016
Dear Angelo Pereira:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For: Courtney H. Lias, Ph.D.
Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162606
Device Name cobas e 801 immunoassay Analyzer Elecsys TSH assay
Indications for Use (Describe)
cobas e 801 immunoassay analyzer is intended for the in-vitro determination of analytes in body fluids.
Elecsys TSH immunoasay is intended for the in vitro quantitative determination of thyrotropin in human serum and plasma. Measurements of TSH are used in the diagnosis of thyroid or pituitary disorders. The Elecsys TSH immunoassay is an electrochemiluminescence immunoasay 'ECLIA', which is intended for use on the cobas e immunoassay analyzers.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Cobas e 801analyzer —Elecsys TSH
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter Name | Roche Diagnostics |
|---|---|
| Address | 9115 Hague RoadP.O. Box 50416Indianapolis, IN 46250-0416 |
| Contact | Angelo PereiraPhone: (317) 521-3544FAX: (317) 521-2324Email: angelo.pereira@roche.com |
| Date Prepared | January 23, 2017 |
| Proprietary Name | cobas e 801 Immunoassay analyzer;Elecsys TSH assay |
| Common Name | Immunoassay analyzer;Thyroid-stimulating hormone test system |
| Classifications | 21CFR862.2160, Chemistry analyzer; Class I21CFR862.1690, Thyroid-stimulating hormone test system Class II |
| Product Codes | JJEJLW |
| Predicate Devices | Elecsys 2010/ Elecsys TSH K961491 |
| Establishment Registration | For cobas e 801 and Elecsys TSH, the establishment registration number forRoche Diagnostics GmbH in Mannheim, Germany is 9610126, and for Penzberg,Germany, 9610529. The establishment registration number for RocheDiagnostics in the United States is 1823260. |
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DEVICE DESCRIPTION 1.
The cobas e 801 immunoassay analyzer is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series cleared under K100853. It uses electrochemiluminescent technology for signal generation and measurement.
INTENDED USE 2.
cobas e 801 immunoassay analyzer is intended for the in vitro determination of analytes in body fluids.
Elecsys TSH is an immunoassay for the in vitro quantitative determination of thyroid stimulating hormone in human serum and plasma. Measurement of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid and pituitary disorders. The electrochemiluminescence immunoassay 'ECLIA' is intended for use on the cobas e
immunoassay analyzers.
DEVICE TO WHICH EQUIVALENCE IS CLAIMED 3.
The cobas e 801 analyzer module is a modified version of the predicate device, the Elecsys 2010 with Elecsys TSH as the representative quantitative assay, cleared under K961491.
A comparison of the significant features of the cobas e 801 and the Elecsys 2010 is provided in the table below.
| Topic | Predicate device: Elecsys 2010 analyzer | Candidate device:cobas e801 analyzermodule |
|---|---|---|
| Basic Features | ||
| Intended Use | Intended for the in vitro determination ofanalytes in body fluids. | Same |
| Measurement principle | Electrochemiluminescence immunoassaymethod (ECLIA) | Same |
| Workflow principle | Batch or random access | Same |
| Throughput | 86 tests/hour | 300 tests/hour/module |
| Table 1: Similarities and differences between the cobas e 801 and Elecsys 2010 analyzers | ||||||
|---|---|---|---|---|---|---|
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| Topic | Predicate device: Elecsys 2010 analyzer | Candidate device:cobas e801 analyzer module |
|---|---|---|
| Sample Handling | ||
| Typical sample volumes | 10-50μL | 4-60 µL |
| Sample types | Serum, plasma, urine, saliva | Same |
| Sample handling system | Via sample disk or racks | Input and transport of samples using universal sample racks, modular sample buffer input, core/transportation unit and STAT port. |
| Sample capacity on board | Disc: 30; rack:75 | 300 |
| Sample identification | Positive id-yes | Same |
| Reagent Handling | ||
| Reagent volume | 10-190 μL | 6-60 µL |
| Onboard storage temperature | 18-22°C | 5-10°C |
| Reagent bottle/Cassette identification | 2-d barcode | RFID |
| Application information transfer to instrument | Via barcode on reagent pack | Electronic transfer via cobas link |
| Test Reaction Chamber | ||
| Temp. control | Incubation at 37°C. | Same |
| Detection | ||
| Measuring unit | 1 | 2 |
| Detection unit | ECL unit with sipper, measuring cell and photomultiplier | Design of the sipper changed to shorten the detection cycle time; measuring cell and photomultiplier are the same |
| Detection time | 1.2 seconds | Same |
| Detection cycle time | 42 sec | 24 sec |
| Software | ||
| Software | Elecsys 2010 Software | cobas 8000 modular System Software |
| Configuration | Stand alone | One PC and one core in combination with several e-modules or c analytical modules |
| Analytical Unit(s) functions | Control of analytic processes (pipetting, incubation, detection) and Primary Signal processing | Same |
| Result calculation | Automated measuring of ECL signal and automated calculation of concentrations via calibration curve | Same |
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Elecsys TSH was used as the representative assay for this submission. Comparative data for the Elecsys TSH assay run on the cobas e 801 and the Elecsys 2010 is provided in the table below.
| Feature | Predicate Device: Elecsys TSH on Elecsys2010 analyzer (K961491) | Candidate Device: Elecsys TSH oncobas e801 analyzer module |
|---|---|---|
| Intended Use | Immunoassay for the in vitro quantitativedetermination of thyroid stimulating hormone inhuman serum and plasma | Same |
| Instrument Platform | Elecsys immunoassay analyzer | Elecsys immunoassay analyzer, part of thecobas 8000 modular analyzer series(K100853) |
| Measurement principle | Electrochemiluminescence immunoassay(ECLIA) method | Same |
| Antibody/ Reagents | Biotinylated monoclonal anti-TSH antibody(mouse)Monoclonal anti-TSH antibody(mouse/human) labeled with rutheniumcomplexStreptavidin -coated microparticles | Same |
| Sample size | 50 µL of sample | 30µL of sample |
| Measuring Range | 0.005-100 µIU/mL | Same |
| Sample Types | Serum, serum with separating gel, Li-heparin,K₂EDTA, K₃EDTAAlso, Sodium citrate and NaF/K oxalate | Serum, serum with separating gel, Li-heparin, K₂EDTA and K₃EDTA. |
Table 2: Similarities and Differences for Elecsys TSH on cobas e 801 versus Elecsys 2010
PERFORMANCE CHARACTERISTICS 4.
Repeatability and Intermediate Precision 4.1.
Precision of the Elecsys TSH assay was evaluated on one cobas e 801 analyzer according to CLSI EP05-A3. One reagent lot was evaluated.
The protocol consisted of testing 2 replicates of each control (PC Universal and PreciControl TS) and human sera (HS) per run, 2 runs per day for 21 days. The samples were run in randomized order on the analyzer. Pooled serum samples were used (Human serum 1-5, 11) and pooled spiked sera (Human serum 6-10).
The results of the precision studies are given in the table below:
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| Repeatability | Intermediate precision | ||||
|---|---|---|---|---|---|
| Sample | Mean(µIU/mL) | SD(µIU/mL)(SD 95% UCL) | CV (%)(UCL* 95%) | SD(µIU/mL)(SD 95% UCL) | CV (%)(UCL* 95%) |
| Human serum 1 | 0.00851 | 0.000600(0.000734) | 7.1 (8.6) | 0.000962(0.00118) | 11.3 (13.8) |
| Human serum 2 | 0.209 | 0.00338(0.00412) | 1.6 (2.0) | 0.00520(0.00624) | 2.5 (3.0) |
| Human serum 3 | 1.88 | 0.0264(0.0322) | 1.4 (1.7) | 0.0432(0.0533) | 2.3 (2.8) |
| Human serum 4 | 51.8 | 0.653(0.797) | 1.3 (1.5) | 1.05(1.26) | 2.0 (2.4) |
| Human serum 5 | 90.0 | 1.24(1.52) | 1.4 (1.7) | 1.75(2.07) | 1.9 (2.3) |
| PC Universal 1 | 1.41 | 0.0197(0.0240) | 1.4 (1.7) | 0.0301(0.0362) | 2.1 (2.6) |
| PC Universal 2 | 8.18 | 0.132(0.161) | 1.6 (2.0) | 0.207(0.250) | 2.5 (3.1) |
| PreciControl TS | 0.184 | 0.00325(0.00397) | 1.8 (2.2) | 0.00417(0.00495) | 2.3 (2.7) |
Linearity 4.2.
Linearity of the Elecsys TSH assay was assessed on the cobas e 801 Immunoassay Analyzer according to CLSI EP6-A. Three high analyte serum samples were diluted with Diluent MultiAssay. 12 concentrations (dilutions) throughout the measuring range were prepared. Samples were assayed in 3-fold determination within a single run. The linearity data were analyzed with regards to linear, quadratic and cubic polynomials according to CLSI EP6-A. A summary of the linearity data is presented below:
Serum 1: intercept = -0.00155, slope = 0.963, Pearson's r = 0.9994
Serum 2 intercept = -0.00193, slope = 0.958, Pearson's r = 0.9992
Serum 3 intercept = -0.00272, slope = 0.952, Pearson's r = 0.9986
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Analytical sensitivity 4.3.
The limit of Blank (LoB) determines the highest observed measurement values for samples free of analyte. It was determined for three reagent lots using 60 replicates (one cobas e 801 instrument, six days, one run per day, one blank sample with ten replicates per run). LoB is 0.0025 µIU/mL
The Limit of Detection (LoD) was determined as the lowest amount of analyte in a sample that can be detected with 95% probability. It was determined for three reagent lots using 60 replicates (one cobas e 801 instrument, six days, one run per day, two replicates per sample per run and five low-level human serum samples). LoD is 0.005 µIU/mL.
The Limit of Quantitation (LoQ) is defined as the mean value of that sample which is the first that fulfills the specification for the intermediate precision and for which no sample with higher concentration exists that exceeds this specification. It was determined for three reagent lots using 10 low level TSH samples tested on one instrument, for five days, one run per day and five replicates per sample. The mean value and the intermediate precision as coefficient of variation (CV) and standard deviation (SD) for each LoQ sample were then calculated. The LoQ is 0.005 µIU/mL at a CV≤ 20 %.
Endogenous interferences 4.4.
The effect on quantitation of analyte in the presence of endogenous interfering substances using the Elecsys TSH was determined on the cobas e 801 Immunoassay analyzer using human serum samples. No interference was observed up to the levels indicated:
| Interferent | No interference seen up to | |
|---|---|---|
| Intralipid (Lipemia) | 2000 | mg/dL |
| Biotin | 56.0 | ng/mL |
| Bilirubin | 66.0 | mg/dL |
| Hemoglobin | 1000 | mg/dL |
| Rheumatic Factor | 1500 | IU/mL |
| human IgG | 2.80 | g/dL |
| human IgM | 0.500 | g/dL |
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4.5. Exogenous interferences- anticoaqulants
The effect on quantitation of analyte in the presence of anticoagulants with the Elecsys TSH Immunoassay was determined by comparing values obtained from samples (single donors, native as well as spiked) drawn into Serum, Li-Heparin, K2-EDTA and K3-EDTA plasma tubes. Anticoagulants: A minimum of 40 serum/plasma pairs per sample material were tested in singleton with one reagent lot on one cobas e 801 Immunoassay Analyzer. Data were evaluated using a regression analysis according to Passing/Bablok and supported the above sample types.
Exogenous interferences- drugs 4.6.
In vitro tests were performed on 16 commonly used drugs. No interference with the assay was found. In addition the following special drugs were tested. No interference with the assay was found to the levels tested:
| Drug | Concentration tested (mg/L) |
|---|---|
| Amiodarone | 200 |
| Carbimazole | 30 |
| Fluocortolone | 100 |
| Hydrocortisone | 200 |
| Iodide | 0.2 |
| Levotyroxine | 0.25 |
| Liothyronine | 0.015 |
| Methimazole | 80 |
| Octreotide | 0.3 |
| Prednisolone | 100 |
| Propanolol | 240 |
| Propylthiouracil | 60 |
| Perchlorate | 2000 |
4.7. Method comparison
A method comparison was performed between the cobas e 801 and the predicate Elecsys 2010. A total of 130 human serum samples (single donors and serum pools; native, spiked as well as diluted) were measured with the Elecsys TSH immunoassay on analyzers in singlicate covering
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the entire measuring range. Sample concentrations were between 0.008 - 92.6 µIU/mL. The summary of the analysis is presented in the table below:
| Passing/Bablok | Linear regression | |
|---|---|---|
| N | 130 | |
| Slope | 0.936 | 0.958 |
| Intercept | -0.003 | -0.052 |
| Correlation coefficient | ||
| Pearson (r) Kendall | - | 0.999 |
| ( $\u03c4$ ) | 0.989 | - |
Expected Values 4.8.
0.27-4.20 µIU/mL
These values correspond to the 2.5th and 97.5th percentiles of results obtained from a total of 516 healthy test subjects examined.
CONCLUSION
The Elecsys TSH assay applied to the cobas e 801 analyzer is substantially equivalent to the predicate device based on the intended use, principle and performance characteristics described above.
§ 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.