(21 days)
Elecsys TSH (current version)
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No
The summary describes a standard immunoassay using electrochemiluminescence and monoclonal antibodies. There is no mention of AI, ML, or any computational analysis beyond standard statistical methods for performance evaluation.
No.
The device is an in vitro diagnostic immunoassay for measuring TSH levels, used for diagnosis of thyroid and pituitary disorders, not for treating them.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "Measurements of TSH are used in the diagnosis of thyroid and pituitary disorders." This indicates the device's output is intended to aid in diagnosing medical conditions.
No
The device is an immunoassay kit, which is a chemical reagent-based diagnostic test, not a software-only medical device. It is intended for use on specific hardware analyzers (cobas e immunoassay analyzers).
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "Immunoassay for the in vitro quantitative determination of thyrotropin in human serum and plasma."
The "Device Description" section also confirms this: "The Elecsys TSH immunoassay is used for the in vitro quantitative determination of thyroid stimulating hormone in human serum and plasma."
The term "in vitro" is a key indicator that the device is intended for use outside of the living body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of thyrotropin in human serum and plasma. Measurements of TSH are used in the diagnosis of thyroid and pituitary disorders.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
JLW
Device Description
The Elecsys TSH immunoassay makes use of a sandwich test principle using monoclonal antibodies specifically directed against human TSH. The antibodies labeled with ruthenium complex) consist of a chimeric construct from human and mouse specific components. The Elecsys TSH immunoassay is used for the in vitro quantitative determination of thyroid stimulating hormone in human serum and plasma. It is intended for use on the cobas e immunoassay analyzers.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
4.1. Repeatability and Intermediate Precision
Precision of the Elecsys TSH assay was evaluated on one cobas e 801 immunoassay analyzer with one reagent lot. The protocol consisted of testing 2 replicates of each control (PreciControl Universal and PC Thyro Sensitive) and human sera (HS) per run, 2 runs per day for 21 days. The samples were run in randomized order on the analyzer. Human serum samples used were all native, single donors as well as pools. Repeatability and Intermediate imprecision were calculated according to EP05-A3. All samples met the predetermined acceptance criterion.
4.2. Lot-to-Lot Reproducibility
Lot-to-lot reproducibility of the Elecsys TSH assay was evaluated on one cobas e 801 analyzer using three reagent lots. A precision study was performed for a total of 21 days (7 days for each lot, n = 28 determinations per lot), 2 replicates of each human sera (HS) per run, 2 runs per day. The samples were run in randomized order on the analyzer. Human serum samples used were all native, single donors (human serum 1) as well as pools (human serum 2-5).
Repeatability, Between-Run, Between-Day, Between-Lot and Total imprecision were calculated according to EP05-A3. Calculated SD's and CV's for the multiple lot (reproducibility) study are comparable to those of the single lot (intermediate) precision study over 21 days using only one reagent lot indicating that the updated assay performs consistently from lot to lot.
4.3. Limit of Blank (LoB)
LoB of the Elecsys TSH was determined according to CLSI EP17-A2. The experimental design included three reagent lots evaluated on one cobas e 801 analyzer, six runs on ≥ three days, with five blank samples with two replicates each per run. In total, 60 determinations for analyte free samples have been obtained. All lots met the predetermined acceptance criterion. The LoB claim in the labeling will be set to 0.0025 µIU/mL.
4.4. Limit of Detection (LoD)
LoD of the Elecsys TSH was determined according to CLSI EP17-A2. The experimental design included three reagent lots evaluated on one cobas e 801 analyzer, six runs on ≥ three days, with five low analyte samples with two replicates each per run. Sixty (60) replicates per sample per reagent lot were run. All lots met the predetermined acceptance criterion. The LoD claim in the labeling will be set to 0.005 µIU/mL.
4.5. Limit of Quantitation (LoQ)
LoQ of the Elecsys TSH was determined according to CLSI EP17-A2. The experimental design included three reagent lots evaluated on one cobas e 801 analyzer for 5 days, one run per day. There were 25 replicates per sample per reagent lot. The LoQ claim in the labeling will be set to 0.005 µIU/mL.
4.6. Linearity/Assay Reportable Range
Linearity of the Elecsys TSH assay was assessed on the cobas e 801 analyzer according to CLSI EP06-A. Three high analyte human serum samples were diluted and concentrations covering the measuring range were measured. Samples were assayed in 3-fold determination within a single run. All deviations were within predetermined acceptance criteria. Linearity for serum samples was confirmed in the range from 0.004 - 102 µIU/mL.
4.7. High Dose Hook Effect
The high-dose hook effect of the Elecsys TSH assay was assessed on the cobas e 801 analyzer in one-fold determination. Three human serum samples were spiked with analyte to achieve high TSH concentrations. For each sample, a dilution series was performed. No hook effect up to 1000 µIU/mL TSH.
4.8. Endogenous Interference
The purpose of this study was to evaluate endogenous substances for potential interference with the parameters measured with the Elecsys TSH on the cobas e 801 analyzer. Substances tested included Biotin, Lipemia (Intralipid), Hemoglobin, Bilirubin, Rheumatoid Factor (RF), Immunoglobulin (IgG, IgM).
4.9. Analytical Specificity/Cross-Reactivity
The effect on quantitation of analyte in the presence of potential cross-reacting compounds using the Elecsys TSH was determined on the cobas e 801 analyzer using a native human serum sample pool. Cross-reactants tested included LH, FSH, hGH, and hCG. All cross-reactivities met the predefined acceptance criterion.
4.10. Exogenous Interferences - Drugs
The effect on quantitation of analyte in the presence of drugs was determined by comparing values obtained from samples spiked with 17 commonly and 13 specially used pharmaceutical compounds with the reference sample (unspiked). Two human serum samples (native serum pools) were used and tested on the cobas e 801 analyzer. For all drugs tested, the specification was met as each compound was found to be non-interfering at the drug concentration.
4.11. Sample Matrix Comparison
The effect on quantitation of analyte in the presence of anticoagulants with the Elecsys TSH immunoassay was determined by comparing values obtained from samples (native human serum samples, single donors as well as pools) drawn into serum and Li-Heparin, K2-EDTA, K3-EDTA plasma tubes. A minimum of 56 serum/plasma pairs per sample material were tested in singleton with one reagent lot on one cobas e 801 analyzer. Data were evaluated using a regression analysis according to Passing/Bablok. The resulting data support the package insert claim that the following sample types are acceptable to use for Elecsys TSH assay: Serum collected using standard serum tubes or tubes containing separating gel, Li-Heparin, K2-EDTA, K3-EDTA plasma and Plasma tubes containing separating gel.
4.12. Method Comparison to Predicate
A method comparison was performed using the Elecsys TSH updated assay (candidate device, Y) and the Elecsys TSH current assay (predicate device, X) to assess the bias between the two assays. A total of 138 samples (129 native human serum samples and 9 diluted human serum samples, single donors as well as pools diluted) were measured in singleton on the cobas e 801 analyzer in one run covering the entire measuring range. All data met predefined acceptance criteria.
4.13. Stability
The stability studies were performed and the pre-specified acceptance criteria were met. The stability data supports Roche Diagnostic's claims as reported in the package inserts.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Elecsys TSH (current version)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, and the words "U.S. FOOD & DRUG ADMINISTRATION" are in blue text.
April 16, 2019
Roche Diagnostics Edie Eads Regulatory Affairs Program Manager 9115 Hague Road Indianapolis, IN 46250
Re: K190773
Trade/Device Name: Elecsys TSH Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: Class II Product Code: JLW Dated: March 25, 2019 Received: March 26, 2019
Dear Edie Eads:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Courtney H. Lias, Ph.D. for 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) K190773
Device Name Elecsys TSH
Indications for Use (Describe)
Immunoassay for the in vitro quantitative determination of thyrotropin in human serum and plasma. Measurements of TSH are used in the diagnosis of thyroid and pituitary disorders.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on 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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Elecsys TSH K190773 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. In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the device described in this Premarket Notification 510(k).
The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA review and clearance for the Elecsys TSH.
| Submitter Name | Roche Diagnostics |
|---|---|
| Address | 9115 Hague Road |
| P.O. Box 50416 | |
| Indianapolis, IN 46250 | |
| Contact | Edie Eads |
| Phone: (317) 521-4668 | |
| Fax : (317) 521-2324 | |
| Email : edie.eads@roche.com |
Secondary Contact: Tammy Dean
Phone: (317) 521-3978
Fax : (317) 521-2324
Email: tammy.dean@roche.com |
| Date Prepared | March 25, 2019 |
| Proprietary Name | Elecsys TSH |
| Common Name | TSH |
| Classification Name | Radioimmunoassay, thyroid-stimulating hormone |
| Product Codes, Regulation Numbers | JLW, 21CFR862.1690 |
| Predicate Device(s) | Elecsys TSH (current version) |
| Establishment Registration | For the Elecsys TSH, the establishment registration
number for Roche Diagnostics GmbH in
Mannheim, Germany is 9610126, and for Penzberg,
Germany, 9610529.
The establishment registration number for Roche
Diagnostics in the United States is 1823260. |
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1. DEVICE DESCRIPTION
The Elecsys TSH immunoassay makes use of a sandwich test principle using monoclonal antibodies specifically directed against human TSH. The antibodies labeled with ruthenium complex) consist of a chimeric construct from human and mouse specific components. The Elecsys TSH immunoassay is used for the in vitro quantitative determination of thyroid stimulating hormone in human serum and plasma. It is intended for use on the cobas e immunoassay analyzers.
1.1. Reagents
The reagent working solutions include: Rack Pack (kit placed on the analyzer)
- . M: Streptavidin-coated microparticles, 1 bottle, 14.1 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative.
- . R1: Anti-TSH-Ab~biotin, 1 bottle, 15.8 mL: Biotinylated monoclonal anti TSH antibody (mouse) 2.0 mg/L; phosphate buffer 100 mmol/L, pH 7.2; preservative.
- R2: Anti-TSH-Ab~Ru(bpy), 1 bottle, 13.9 mL: Monoclonal anti TSH antibody . (mouse/human) labeled with ruthenium complex 1.5 mg/L; phosphate buffer 100 mmol/L, pH 7.2; preservative.
The following changes are proposed to block the interference of biotin with the Elecsys TSH assay. Briefly, Roche is taking a two-step approach by adding an antibody to bind free biotin in the sample, and changing the linker on the biotinylated capture antibody.
For the neutralization of free biotin in serum and plasma, Roche developed an antibody which binds to free biotin. The antibodies are specific for free biotin and do not bind to, or interact with, the biotin-linker conjugates.
In the updated biotinylated antibody conjugate, the distance between biotin and the reactive MEA group is elongated by a PEG spacer which provides the coupled biotin more flexibility for the interaction with the Streptavidin matrix. No change is made to the antibody (immunologically reactive component) which still recognizes the same epitope.
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2. INDICATIONS FOR USE
Immunoassay for the in vitro quantitative determination of thyrotropin in human serum and
plasma. Measurements of TSH are used in the diagnosis of thyroid and pituitary disorders.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e immunoassay analyzers.
3. TECHNOLOGICAL CHARACTERISTICS
The following table compares the Elecsys TSH (K190773) with its predicate device, Elecsys TSH (K162606).
| Feature | Elecsys TSH (K162606) | Elecsys TSH (K190773) |
|---|---|---|
| Intended | ||
| Use/Indications for Use | Elecsys TSH immunoassay 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 and pituitary | ||
| disorders. | ||
| The Elecsys TSH immunoassay is an | ||
| electrochemiluminescence immunoassay | ||
| "ECLIA", which is intended for use on the cobas e | ||
| immunoassay analyzers. | Same. | |
| Detection Method | Electrochemiluminescence "ECLIA" | Same |
| Applications/Test Time | 18 minute | Same |
| Test Format | Sandwich | Same |
| Instrument Platform | cobas e immunoassay analyzers | Same |
| Test Type | Quantitative | Same |
| Assay Protocol | R1+R2+sample, incubation, +beads, | |
| incubation | Same | |
| Handling of R1 and R2 | Liquid, ready to use | Same |
| Pipetting volume | 50 µL | Same |
| Sample Type/Matrix | Human serum, plasma | Same |
| Sample Anticoagulants | Li-heparin, K2-EDTA and K3-EDTA plasma. | Same |
| Calibrator | TSH CalSet | Same |
| Calibration Method | 2-point calibration | Same |
| Feature | Elecsys TSH (K162606) | Elecsys TSH (K190773) |
| Calibration Interval | Calibration must be performed once per reagent lot | |
| using fresh reagent (i.e. not more than 24 hours | ||
| since the cobas e pack was registered on the | ||
| analyzer). | ||
| Calibration interval may be extended based on | ||
| acceptable verification of calibration by the | ||
| laboratory. | Same | |
| Controls | PreciControl Universal and | |
| PreciControl TS | Same | |
| Traceability/ | ||
| Standardization | 2nd IRP WHO Reference Standard 80/558 | Same |
| Reagent Stability | Store at 2 8 °C. Do not freeze. | |
| Store the cobas e pack upright in order to ensure | ||
| complete availability of the microparticles during | ||
| automatic mixing prior to use. | ||
| Unopened at 2-8°C – up to stated expiration date | ||
| On the cobas e 801 analyzer – 16 weeks | Same | |
| Limitations | Biotin ≤ 102 nmol/L or ≤ 25 ng/mL | |
| Samples should not be taken from patients | ||
| receiving therapy with high biotin doses (i.e. > 5 | ||
| mg/day) until at least 8 hours following the last | ||
| biotin administration. | Two-step approach adding an | |
| antibody to bind free biotin in the | ||
| sample and changing the linker on | ||
| the biotinylated capture antibody. | ||
| Biotin ≤ 4912 nmol/L or ≤ 1200 ng/mL | ||
| Biotin interference This assay has | ||
| no biotin interference in serum | ||
| concentrations up to 1200 ng/mL. | ||
| Some studies have shown that serum | ||
| concentrations of biotin can reach up | ||
| to 355 ng/mL within the first hour | ||
| after biotin ingestion for subjects | ||
| consuming supplements of 20 mg | ||
| biotin per day and up to 1160 ng/mL | ||
| for subjects after a single dose of | ||
| 300 mg biotin. | ||
| Measuring Range | 0.005-100 µIU/mL | Same |
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4. NON-CLINICAL PERFORMANCE EVALUATION
The non-clinical performance studies for the Elecsys TSH are summarized below.
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4.1. Repeatability and Intermediate Precision
Precision of the Elecsys TSH assay was evaluated on one cobas e 801 immunoassay analyzer with one reagent lot. The protocol consisted of testing 2 replicates of each control (PreciControl Universal and PC Thyro Sensitive) and human sera (HS) per run, 2 runs per day for 21 days. The samples were run in randomized order on the analyzer. Human serum samples used were all native, single donors as well as pools. Repeatability and Intermediate imprecision were calculated according to EP05-A3. All samples met the predetermined acceptance criterion. The following table summarizes the precision data for the Elecsys TSH.
| cobas e 801 analyzer | |||||
|---|---|---|---|---|---|
| Repeatability | Intermediate precision | ||||
| Sample | Mean µIU/mL | SD µIU/mL | CV % | SD µIU/mL | CV % |
| Human serum 1 | 0.015 | 0.001 | 3.4 | 0.002 | 11.2 |
| Human serum 2 | 0.281 | 0.003 | 1.1 | 0.005 | 1.8 |
| Human serum 3 | 4.09 | 0.030 | 0.7 | 0.090 | 2.2 |
| Human serum 4 | 59.8 | 0.494 | 0.8 | 1.10 | 1.8 |
| Human serum 5 | 95.6 | 0.706 | 0.7 | 3.81 | 4.0 |
| PCb) Universal 1 | 1.39 | 0.013 | 1.0 | 0.021 | 1.5 |
| PC Universal 2 | 7.99 | 0.064 | 0.8 | 0.132 | 1.6 |
| PC Thyro Sensitive | 0.176 | 0.002 | 1.2 | 0.004 | 2.1 |
4.2. Lot-to-Lot Reproducibility
Lot-to-lot reproducibility of the Elecsys TSH assay was evaluated on one cobas e 801 analyzer using three reagent lots. A precision study was performed for a total of 21 days (7 days for each lot, n = 28 determinations per lot), 2 replicates of each human sera (HS) per run, 2 runs per day. The samples were run in randomized order on the analyzer. Human serum samples used were all native, single donors (human serum 1) as well as pools (human serum 2-5).
Repeatability, Between-Run, Between-Day, Between-Lot and Total imprecision were calculated according to EP05-A3. Calculated SD's and CV's for the multiple lot (reproducibility) study are
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comparable to those of the single lot (intermediate) precision study over 21 days using only one reagent lot indicating that the updated assay performs consistently from lot to lot.
4.3. Limit of Blank (LoB)
LoB of the Elecsys TSH was determined according to CLSI EP17-A2. The experimental design included three reagent lots evaluated on one cobas e 801 analyzer, six runs on ≥ three days, with five blank samples with two replicates each per run. In total, 60 determinations for analyte free samples have been obtained. All lots met the predetermined acceptance criterion. The LoB claim in the labeling will be set to 0.0025 µIU/mL.
4.4. Limit of Detection (LoD)
LoD of the Elecsys TSH was determined according to CLSI EP17-A2. The experimental design included three reagent lots evaluated on one cobas e 801 analyzer, six runs on ≥ three days, with five low analyte samples with two replicates each per run. Sixty (60) replicates per sample per reagent lot were run. All lots met the predetermined acceptance criterion. The LoD claim in the labeling will be set to 0.005 µIU/mL.
4.5. Limit of Quantitation (LoQ)
LoQ of the Elecsys TSH was determined according to CLSI EP17-A2. The experimental design included three reagent lots evaluated on one cobas e 801 analyzer for 5 days, one run per day. There were 25 replicates per sample per reagent lot. The LoQ claim in the labeling will be set to 0.005 µIU/mL.
4.6. Linearity/Assay Reportable Range
Linearity of the Elecsys TSH assay was assessed on the cobas e 801 analyzer according to CLSI EP06-A. Three high analyte human serum samples were diluted and concentrations covering the measuring range were measured. Samples were assayed in 3-fold determination within a single run. All deviations were within predetermined acceptance criteria. Linearity for serum samples was confirmed in the range from 0.004 - 102 µIU/mL.
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4.7. High Dose Hook Effect
The high-dose hook effect of the Elecsys TSH assay was assessed on the cobas e 801 analyzer in one-fold determination. Three human serum samples were spiked with analyte to achieve high TSH concentrations. For each sample, a dilution series was performed. No hook effect up to 1000 µIU/mL TSH.
4.8. Endogenous Interference
The purpose of this study was to evaluate endogenous substances for potential interference with the parameters measured with the Elecsys TSH on the cobas e 801 analyzer.
Biotin: One aliquot of each serum sample was spiked with the interfering substance, another aliquot was spiked with the same volume of isotonic NaCl solution (dilution pool). The interfering pool was then diluted into the dilution pool in 10 % increments. The recovery for each sample was calculated by comparison to the reference (unspiked) sample. The claim in the package insert will be set to ≤ 1200 ng/mL.
Lipemia (Intralipid): One aliquot of each serum sample was spiked with the interfering substance, and another aliquot was spiked with the same volume of isotonic NaCl solution (dilution pool). The interfering pool was then diluted into the dilution pool in 10% increments. The recovery for each sample was calculated by comparison to the reference (unspiked) sample. The claim in the package insert will be set to ≤ 1500 mg/dL.
Hemoglobin: Fresh hemolysate was prepared from fresh EDTA or heparin blood. One aliquot of each serum sample was spiked with the hemolysate (interfering pool), another aliquot was spiked with the same volume of isotonic NaCl solution (dilution pool). The interfering pool was then diluted into the dilution pool in 10% increments. The claim in the package insert will be set to ≤ 1000 mg/dL.
Bilirubin: One aliquot of each serum sample was spiked with the interfering substance, and another aliquot with was spiked with the same volume of the solvent (0.1 mol/L NaOH) of the interfering substance (dilution pool). The interfering pool was then diluted into the dilution pool in 10% increments. The claim in the package insert will be set to ≤ 41 mg/dL.
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Rheumatoid Factor (RF): One aliquot of each serum sample was spiked with the interfering substance, and another aliquot with the same volume of the solvent (buffer matrix) of the interfering substance (dilution pool). The interfering pool was then diluted into the dilution pool in 10% increments. The recovery for each sample was calculated by comparison to the reference sample. The claim in the package insert will be set to