(271 days)
The Elecsys FT4 II Assay is for the in vitro quantitative determination of free Thyroxine in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Elecsys FT4 II CalSet is used for calibrating the quantitative Elecsys FT4 II assay on the Elecsys and cobas e immunoassay analyzers.
- The Elecsys F4 II Assay is a quantitative test for determination of free thyroxine in human serum and plasma. The total duration of the assay is 18 minutes. Elecsys FT4 II is a two-step competitive immunoassay with streptavidin microparticles, T4-specific polyclonal anti-T4-antibody (sheep) labeled with a sulfonyl-ruthenium complex, and electrochemiluminescence detection. Results are determined via a calibration curve which is instrument-specifically generated by a two-point calibration and a master curve provided via the reagent barcode.
(2) The Elecsys FT4 II CalSet is a ready-for-use buffer/protein (bovine serum albumin) matrix with added L-Thyroxine in two concentration ranges. FT4 II Cal1: 2 bottles, each containing 1.0 mL of calibrator 1 FT4 II Cal2: 2 bottles, each containing 1.0 mL of calibrator 2 Note: The reagent and calibrator are packaged separately.
Here's a breakdown of the acceptance criteria and the study details for the Elecsys FT4 II Assay, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance for Elecsys FT4 II Assay
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance (Elecsys FT4 II Assay) |
|---|---|---|
| Precision | Repeatability (Within-run): - Concentrations ≤ 0.4 ng/dL: SD ≤ 0.02 ng/dL - Concentrations > 0.4-7.77 ng/dL: CV ≤ 5% Intermediate (Within-laboratory): - Concentrations ≤ 0.4 ng/dL: SD ≤ 0.03 ng/dL - Concentrations > 0.4-7.77 ng/dL: CV ≤ 8% | Repeatability: - HS 1 (0.138 ng/dL): 4.0% CV (SD 0.006 ng/dL) - HS 2 (1.03 ng/dL): 1.3% CV (SD 0.013 ng/dL) - HS 3 (1.90 ng/dL): 1.3% CV (SD 0.024 ng/dL) - HS 4 (4.93 ng/dL): 1.7% CV (SD 0.082 ng/dL) - HS 5 (7.09 ng/dL): 1.8% CV (SD 0.127 ng/dL) Intermediate: - HS 1 (0.138 ng/dL): 7.6% CV (SD 0.011 ng/dL) - HS 2 (1.03 ng/dL): 2.3% CV (SD 0.023 ng/dL) - HS 3 (1.90 ng/dL): 2.1% CV (SD 0.040 ng/dL) - HS 4 (4.93 ng/dL): 3.3% CV (SD 0.163 ng/dL) - HS 5 (7.09 ng/dL): 4.5% CV (SD 0.319 ng/dL) (All results meet specifications) |
| Limit of Blank (LoB) | Claim will be set to ≤ 0.03 ng/dL. | LoB claim will be set to ≤ 0.03 ng/dL. (Study determined this value) |
| Limit of Detection (LoD) | Claim will be set to ≤ 0.05 ng/dL. | LoD claim will be set to ≤ 0.05 ng/dL. (Study determined this value) |
| Limit of Quantitation (LoQ) / Functional Sensitivity | Interassay coefficient of variation ≤ 20%. | Lot MP02: 0.059 ng/dL Lot P2: 0.069 ng/dL Lot P3: 0.080 ng/dL. Claim will be set to 0.1 ng/dL. (All lots show functional sensitivity below the claimed LoQ) |
| Linearity | Significance level for deviation to higher order polynomial: 5%. Limits for deviation of higher order polynomial regression: - 0.1 - 0.388 ng/dL: ±0.078 ng/dL - > 0.388 - 7.77 ng/dL: ± 10% Repeatability for linearity: - 0.1 - 0.388 ng/dL: ±0.039 ng/dL - > 0.388 - 7.77 ng/dL: ± 5% | Linearity was confirmed in the range from 0.096 to 8.20 ng/dL. (Meets acceptance criteria) |
| Exogenous Interferences - Drugs | Recovery of 100 ± 10% of the reference value (unspiked sample). | All compounds tested, except Levothyroxine and Furosemide, were found to be non-interfering. Levothyroxine and Furosemide will be listed as interfering substances. (Meets criteria for most, with noted exceptions) |
| Exogenous Interferences - Anticoagulants | For regression analysis: - Slope: 0.9 - 1.1 - Intercept: < ± 0.05 ng/dL - Coefficient of correlation r ≥ 0.95 For single pairs: - LoD < 0.3 ng/dL: ± 0.05 ng/dL - ≥ 0.3 - 7.77 ng/dL: ± 10 % of reference value | Specifications were met for all anticoagulants. The resulting data support the use of serum, Li-Heparin, K2-EDTA-, and K3-EDTA-plasma specimens. (Meets acceptance criteria) |
| Endogenous Interferences | Recovery of 100 ± 10% of unspiked reference value. | The assay is unaffected by icterus (bilirubin < 701 µmol/L or < 41 mg/dL), hemolysis (Hb < 0.621 mmol/L or < 1.0 g/dL), lipemia (Intralipid < 2000 mg/dL), biotin (< 81.8 nmol/L or < 20 ng/mL), Albumin <6.3 g/dL, IgG < 7 g/dL, IgA < 1.6 g/dL and IgM < 1 g/dL. (Meets acceptance criteria) |
| Method Comparison (vs. predicate) | For Passing/Bablok regression: - Slope: 1.00 ± 0.05 - Intercept: ± 0.04 ng/dL - Correlation: r ≥ 0.95 Bias at medical decision points: - ±10% at 0.93 ng/dL - ±10% at 1.7 ng/dL | Results not explicitly stated in this section, but the conclusion states "The data demonstrate that the performance of the Elecsys FT4 II Assay is substantially equivalent to that of the predicate device". (Implies criteria were met) |
| Calibration Stability | Recovery compared to Day 0 value: - LoD - 0.3 ng/dL: ± 0.05 ng/dL - > 0.3 – 7.77 ng/dL: 100 ± 10 % | No direct results given, but the study description implies successful demonstration up to 28 days for using Day 0 calibration. (Implies criteria were met) |
| Reagent On-Board Stability | Recovery of samples compared to Day 1: - LoD to 0.3 ng/dL: ± 0.05 ng/dL - >0.3 to 7.77 ng/dL: 100±10% | Reagent kits can be stored on board for up to 28 days, and for 56 days with alternative storage (max 120 hours onboard). A new calibration is recommended every 7 days. (Implies criteria were met within these guidelines) |
| Reagent Accelerated Stability | Recovery of samples compared to Day 0: - LoD to 0.3 ng/dL: ± 0.05 ng/dL - >0.3 to 7.77 ng/dL: 100 ± 10% | No direct results given, but used to support a 12-month shelf life claim. (Implies criteria were met for 3 weeks at 35°C, extrapolating to 12 months shelf life) |
| Reagent Real-Time Stability | Recovery of 90-110% of the reference value. | In ongoing study, data for 0, 7, 10, 13, 16, 19, and 25 months will be available. Supports a 12-month shelf life claim based on both accelerated and initial real-time data. Study will continue for 24 months. (On-going, current data supports 12 months) |
| Reagent Stability after first opening (2-8°C) | Recovery of samples compared to Day 0: - ≤ 0.3 ng/dL: ± 0.05 ng/dL - > 0.3 - 7.77 ng/dL: 100 ± 10 % | Supports 84 days (12 weeks) when stored at 2-8ºC. (Implies criteria were met up to 85 days in the study) |
| Reference Range Validation | No more than 6 (10%) of the 60 tested subjects should fall outside of the established reference range of 0.93-1.7 ng/dL. | 2 of 60 subjects fell outside the established reference range (0.93-1.7 ng/dL). Acceptance criteria met. The reference range can be transferred. (Meets acceptance criteria) |
2. Sample Sizes Used for the Test Set and Data Provenance
The document describes several performance studies, each with its own sample size:
- Precision (CLSI EP5-A2):
- Sample Size: 84 determinations for each of 5 human serum samples (HS 1-5) and 2 PreciControl Universal (PCU 1-2). Tested in 2 replicates per sample/control per run, 2 runs per day for 21 days.
- Data Provenance: Human sera (HS) and PreciControl Universal (PCU). No explicit country of origin is stated, but standard CLSI guidelines imply well-characterized, often commercially sourced, samples. The study is prospective in nature for assessing device performance.
- Limit of Blank (LoB) (CLSI EP17-A2):
- Sample Size: 60 determinations of one analyte-free human serum sample (5-fold determination in each run, 1-2 runs/day for 4 days).
- Data Provenance: Analyte-free human serum (T4 depleted).
- Limit of Detection (LoD) (CLSI EP17-A2):
- Sample Size: Single measurement per run for four days on five low-level human serum samples. Total determinations not explicitly summed, but would be 5 samples * 1 measurement * (1-2 runs/day) * 4 days.
- Data Provenance: Low-level human serum samples.
- Limit of Quantitation (LoQ) / Functional Sensitivity (CLSI EP17-A2):
- Sample Size: 8 low-level human serum samples tested in single replicates for four days, 1-2 runs per day. Total determinations not explicitly summed.
- Data Provenance: Native human serum samples diluted with analyte-free human serum matrix.
- Linearity (CLSI EP6-A):
- Sample Size: 3 high analyte serum sample pools. For each pool, 13 concentrations (11 dilutions) across the measuring range were prepared and assayed in 3-fold determination within a single run.
- Data Provenance: Human serum samples (spiked with L-Thyroxine) and fT4 depleted human serum.
- Specificity/Cross Reactivity:
- Sample Size: Not explicitly stated, but compounds were tested in duplicate.
- Data Provenance: Native human serum samples or human serum samples spiked with L-Thyroxine (single donors) spiked with potential cross-reactant compounds.
- Exogenous Interferences - Drugs:
- Sample Size: 2 human serum samples approximately 1.1 ng/dL and 2.6 ng/dL of fT4. Each was spiked with 17 pharmaceutical compounds and 12 thyroid drugs/Furosemide. Spiked aliquots tested in triplicate, reference aliquot in 6-fold determination.
- Data Provenance: Human serum samples (pools spiked with L-Thyroxine).
- Exogenous Interferences - Anticoagulants:
- Sample Size: Between 53 and 63 serum/plasma pairs per sample material (presumably per type of anticoagulant). Tested in single determination.
- Data Provenance: Native samples or samples spiked with L-Thyroxine (single donors) drawn into various primary tubes (serum, Li-Heparin, K2-EDTA, K3-EDTA-plasma, Li-Heparin Plasma Separation Tubes).
- Endogenous Interferences:
- Sample Size: 3 serum samples (low, mid, high fT4 concentrations) for each interfering substance.
- Data Provenance: Pooled human serum samples spiked with L-Thyroxine.
- Method Comparison (vs. predicate):
- Sample Size: 170 human serum samples. Out of these, 11 were spiked with analyte, and 4 diluted with FT4 free serum.
- Data Provenance: Human serum obtained from commercial vendors or remnant clinical samples.
- Calibration Stability:
- Sample Size: 5 human serum samples (spiked with L-Thyroxine) and 2 controls. Each tested in duplicate.
- Data Provenance: Human serum samples and controls.
- Reagent On-Board Stability:
- Sample Size: Not explicitly stated, but refers to testing "samples" and controls at various time points.
- Data Provenance: Human serum samples and controls.
- Reagent Accelerated Stability:
- Sample Size: 5 human serum samples (spiked with L-Thyroxine) and 2 controls. Each tested in two-fold determination.
- Data Provenance: Human serum samples and controls.
- Reagent Real-Time Stability:
- Sample Size: PreciControl Universal 1 and PreciControl Universal 2 tested in duplicate at various time points (0, 7, 10, 13, 16, 19, 25 months).
- Data Provenance: PreciControl Universal 1 and 2 (controls).
- Reagent Stability after first opening (2-8°C):
- Sample Size: 5 human serum samples (spiked with L-Thyroxine) and 2 controls. Each tested in two-fold determination.
- Data Provenance: Human serum samples and controls.
- Reference Range Validation Study (CLSI C28-A3c):
- Sample Size: 60 subjects (30 males and 30 females).
- Data Provenance: Subjects with normal TSH values (presumed healthy individuals). The study is prospective for reference range validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of immunoassay (Elecsys FT4 II Assay) is a quantitative chemical measurement device. The "ground truth" for its performance is established through comparison to established analytical methods and reference standards, rather than expert interpretation of images or clinical findings.
- For studies like Linearity, Specificity, Interferences, and Analytical Sensitivity, ground truth samples are typically prepared with known concentrations of analytes or interferents, or are compared against validated reference methods.
- For Method Comparison, the ground truth is established by comparing the new device's results against a legally marketed predicate device (Elecsys FT4 Assay, K961489), which itself would have been validated against reference methods or clinical outcomes.
- For the Reference Range Validation Study, the "ground truth" for subject selection was having "normal TSH values" as measured by the Elecsys TSH assay, identifying a healthy population.
Therefore, the concept of "experts establishing ground truth" in the traditional sense (e.g., radiologists reviewing images) is not directly applicable here. The ground truth is inherent in the design of the analytical studies and the use of calibrated standards and reference methods.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is a quantitative chemical measurement device; results are numerical and not subject to human interpretation or adjudication in the way a diagnostic imaging study would be. Deviations from expected values or comparisons to reference methods would be evaluated statistically.
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
Not applicable. This is not a device involving human readers interpreting cases or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the device (Elecsys FT4 II Assay) functions as a standalone, automated immunoassay without human intervention in the measurement process itself. All performance studies described (Precision, LoB, LoD, LoQ, Linearity, Specificity, Interferences, Method Comparison, Stability studies) evaluate the algorithm's performance and the device's analytical characteristics directly.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth used across the various studies for this in vitro diagnostic device includes:
- Known concentrations: For studies like LoB, LoD, LoQ, Linearity, Specificity, and Interferences, samples are often prepared with precisely known concentrations of the analyte or interfering substances.
- Predicate device comparison: For method comparison, the results are compared to the legally marketed Elecsys FT4 Assay (K961489), which serves as the established analytical "truth" for substantial equivalence.
- Biological/clinical normality: For the Reference Range Validation Study, the ground truth for inclusion criteria was "normal TSH values" in healthy individuals.
- Calibration standards: The assays rely on accurate calibration using the Elecsys FT4 II CalSet, which is itself traceable to established standards (Enzymun-Test, standardized using equilibrium dialysis for FT4).
8. The Sample Size for the Training Set
Not applicable in the typical sense of machine learning. This is an immunoassay, not an AI or machine learning algorithm that requires a "training set" to learn patterns. The "training" of such a system would involve optimizing assay reagents and parameters during development, based on extensive R&D, but not a distinct "training set" of patient data as understood in AI/ML contexts.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there isn't a "training set" in the context of an immunoassay. The development and optimization of the assay would rely on:
- Analytical chemistry principles: Designing the competitive immunoassay with specific antibodies and detection systems.
- Biochemical characterization: Ensuring the specificity of T4-specific antibodies.
- Manufacturing controls: Producing reagents with consistent quality and concentration.
- Calibration curve development: Establishing the relationship between signal (electrochemiluminescence) and analyte concentration using a predefined set of calibrators with known concentrations that are traceable to reference methods (e.g., equilibrium dialysis).
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CONFIDENTIAL
JAN 2 7 2014
510(k) Summary
According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter Name, Address, Contact
Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250
Contact Person: Edie Eads
- Phone: (317) 521-4668 .
- . FAX: (317) 521-2324
- Email: edie.eads@roche.com .
Date Prepared: January 21, 2014
| Device Name | Proprietary name: | (1) Elecsys FT4 II Assay(2) Elecsys FT4 II CalSet |
|---|---|---|
| Common name: | (1) FT4 II Assay(2) FT4 II Calibrator | |
| Classification name: | (1) Radioimmunoassay, Free thyroxine test system(2) Calibrator | |
| Product Codes: | (1) CEC, 21 CFR 862.1695(2) JIT, 21 CFR 862.1150 | |
| Predicate Devices: | (1) Elecsys FT4 Assay (K961489)CEC, 21 CFR 862.1695(2) Elecsys FT4 CalSet (K961489)JIS, 21 CFR 862.1150 | |
| EstablishmentRegistration | For the Elecsys FT4 II Assay and the Elecsys FT4 II CalSet, theestablishment registration number for Roche Diagnostics GmbH inMannheim, Germany, is 9610126 and for Penzberg, Germany, is 9610529. |
The establishment registration number for Roche Diagnostics United States is
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| DeviceDescription | 1) The Elecsys F4 II Assay is a quantitative test for determination of freethyroxine in human serum and plasma. The total duration of the assay is 18minutes. Elecsys FT4 II is a two-step competitive immunoassay withstreptavidin microparticles, T4-specific polyclonal anti-T4-antibody (sheep)labeled with a sulfonyl-ruthenium complex, and electrochemiluminescencedetection. Results are determined via a calibration curve which is instrument-specifically generated by a two-point calibration and a master curve providedvia the reagent barcode.(2) The Elecsys FT4 II CalSet is a ready-for-use buffer/protein (bovine serumalbumin) matrix with added L-Thyroxine in two concentration ranges.FT4 II Cal1: 2 bottles, each containing 1.0 mL of calibrator 1 FT4 II Cal2: 2 bottles, each containing 1.0 mL of calibrator 2 Note: The reagent and calibrator are packaged separately. |
|---|---|
| IntendedUse/Indicationsfor Use | Elecsys FT4 II Reagent:The Elecsys FT4 II Assay is for the in vitro quantitative determinationof free Thyroxine in human serum and plasma. Measurementsobtained by this device are used in the diagnosis and treatment ofthyroid diseases. |
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
- Elecsys FT4 II CalSet: Elecsys FT4 II CalSet is used for calibrating . the quantitative Elecsys FT4 11 assay on the Elecsys and cobas e immunoassay analyzers.
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CONFIDENTIAL
510(k) Summary, continued
| SubstantialEquivalence | The Elecsys FT4 II Test System is substantially equivalent to otherdevices legally marketed in the United States.(1) Elecsys FT4 II Assay is equivalent to the Elecsys FT4 Assay(K961489).(2) Elecsys FT4 II CalSet is equivalent to the Elecsys FT4 CalSet(K961489). |
|---|---|
| SubstantialEquivalence -Comparison | The following tables compare the Elecsys FT4 II Test System and theElecsys FT4 II CalSet with their predicates. |
Comparison of Assays-Similarities and Differences
| Feature | Elecsys FT4 II Assay | Predicate Device: Elecsys FT4 Assay (K961489) |
|---|---|---|
| General Assay Features | ||
| Intended Use/ Indications for Use | The FT4 II Assay is for the in vitro quantitative determination of free Thyroxine in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. | Immunoassay for the in vitro quantitative determination of free Thyroxine in human serum and plasma.The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. |
| Assay Protocol | Quantitative electrochemiluminescence immunoassay | Same |
| Detection Protocol | Electrochemiluminescence | Same |
| Applications | 18-minute application | Same |
| Assay Comparison | ||
| Feature | Elecsys FT4 II Assay | Predicate Device: Elecsys FT4 Assay (K961489) |
| General Assay Features | ||
| Instrument Platform | cobas e 411, | cobas e 411, Elecsys 2010,MODULAR ANALYTICS E170,cobas e 411, cobas e 601 and cobas e 602 |
| Sample Volume | 15 µL | Same |
| Sample Type | Undiluted human serum and undilutedplasma treated with Li-heparin, K2-EDTA, and K3-EDTA. | Undiluted human serum and undilutedplasma treated with Li-, Na-, NH+4 -heparin, K3-EDTA, sodium citrate,and sodium fluoride/potassium oxalate. |
| Reagents | The Elecsys FT4 II assay is acompetitive immunoassay whichincludes a specific polyclonal anti-T4-antibody (sheep) labeled with asulfonyl-ruthenium complex,thyroxine labeled with biotin andstreptavidin coated microparticles. | The Elecsys FT4 assay is acompetitive immunoassay whichincludes a specific anti-T4 antibodylabeled with a ruthenium complex,thyroxine labeled with biotin andstreptavidin coated microparticles. |
| Calibrator | Elecsys FT4 II CalSet, 2 levels | Elecsys FT4 CalSet, 2 levels |
| Calibration Interval | Calibration of an Elecsys FT4 IIreagent lot is recommended every 28days. During that time period, freshreagent kits of the same lot can beused without calibration by using thecalibration curve of the Day 0 reagentkit. Renewed calibration isrecommended as follows:• After 1 month (28 days) whenusing the same reagent lot.• After 7 days (when using thesame reagent kit on theanalyzer).As required: e.g. quality controlfindings outside the specified limits | Same |
| Controls | Elecsys PreciControl Universal orother suitable control material | Same |
| Assay Comparison | ||
| Feature | Elecsys FT4 II Assay | Predicate Device: Elecsys FT4 Assay (K961489) |
| General Assay Features | ||
| Traceability /Standardization | The Elecsys FT4 II Assay has beenstandardized against the Elecsys FT4method. The Elecsys FT4 assay istraceable to the Enzymun-Test whichwas standardized using equilibriumdialysis. | The Elecsys FT4 Assay has beenstandardized against theEnzymun-Test FT4 method,which was standardized usingequilibrium dialysis. |
| ReagentStability | Unopened at 2-8 °C—up to statedexpiration date | Same |
| After opening at 2-8 °C—84 days (12weeks) | Same | |
| On the Elecsys and cobas eimmunoassay analyzers – 28 days (4weeks) onboard or 56 days when storedalternatively in the refrigerator and onthe analyzer, with the total timeonboard the analyzer not exceeding 120hours. | On the Elecsys and cobas eimmunoassay analyzers – 4weeks onboard |
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| Assay Comparison | ||
|---|---|---|
| Feature | Elecsys FT4 II Assay | Predicate Device: Elecsys FT4 Assay (K961489) |
| Labeled Performance Characteristics | ||
| Measuring Range | 0.1 ng/dL to 7.77 ng/dL(1.3 - 100 pmol/L) | 0.300-100 pmol/L |
| Precision | cobas e 411:Within-run (will be labeled Repeatability) n=84, human seraHS 1: 4.0% CV @ 0.138 ng/dL (1.78 pmol/L)HS 2: 1.3% CV @ 1.03 ng/dL (13.3 pmol/L)HS 3: 1.3% CV @ 1.90 ng/dL (24.5 pmol/L)HS 4: 1.7% CV @ 4.93 ng/dL (63.5 pmol/L)HS 5: 1.8% CV @ 7.09 ng/dL (91.2 pmol/L)Total (will be labeled Intermediate)HS 1: 7.6% CV @ 0.138 ng/dL (1.78 pmol/L)HS 2: 2.3% CV @ 1.03 ng/dL (13.3 pmol/L)HS 3: 2.1% CV @ 1.90 ng/dL (24.5 pmol/L)HS 4: 3.3% CV @ 4.93 ng/dL (63.5 pmol/L)HS 5: 4.5% CV @ 7.09 ng/dL (91.2 pmol/L) | Elecsys 2010 and cobas e 411:Within-run (will be labeled Repeatability) n=60, human seraHS 1: 1.6% CV @ 8.7 pmol/LHS 2: 1.7% CV @ 21.1 pmol/LHS 3: 2.9% CV @ 50.8 pmol/LTotal (will be labeled Intermediate)HS 1: 3.5% CV @ 8.7 pmol/LHS 2: 3.3% CV @ 21.1 pmol/LHS 3: 6.6% CV @ 50.8 pmol/LMODULAR ANALYTICS E170, cobas e 601 , and cobas e 602:Within-run (will be labeled Repeatability) n=60, human seraHS 1: 1.4% CV @ 9.15 pmol/LHS 2: 1.8% CV @ 16.9 pmol/LHS 3: 2.0% CV @ 34.2 pmol/LTotal (will be labeled Intermediate)HS 1: 2.7% CV @ 14.9 pmol/LHS 2: 2.6% CV @ 17.5 pmol/LHS 3: 3.6% CV @ 42.7 pmol/L |
| Assay Comparison | ||
| Feature | Elecsys FT4 II Assay | Predicate Device: Elecsys FT4 Assay (K961489) |
| AnalyticalSensitivity | Limit of Blank (LoB): 0.03 ng/dL(0.4 pmol/L)Limit of Detection (LoD): 0.05 ng/dL(0.6 pmol/L)Limit of Quantitation (LoQ) (FunctionalSensitivity) 0.1 ng/dL(1.3 pmol/L) with an intermediateprecision of ≤ 20% | Lower Detection Limit: 0.300 pmol/L |
| AnalyticalSpecificity | Cross ReactantL-T3D-T3rT33-iodo-L-trosine3,5-diiodo-L-tyrosine3,3',5-triiodohyoacetic acid3,3',5,5'- tetraiodothyroacetic acid | CrossReactivity(%)L-T4 100D-T4 100L-T3 1.53D-T3 1.383-iodo-L-tyrosine 0.0023,5-diiodo-L-tyrosine 0.013,3',5,5;-tetraiodothyroacetic acid 38.5 |
| CrossReactivity(%)≤ 0.005≤ 0.001≤ 0.003≤ 0.000≤ 0.000≤ 0.0002<0.001 | ||
| Hook Effect | There is no high-dose hook effect sincethe Elecsys FT4 II assay is a competitiveassay | Same |
| Limitations | The assay is unaffected by:Icterus (bilirubin < 701 µmol/L or <41 mg/dL)Hemolysis (Hb < 0.621 mmol/L or <1.0 g/dL)Lipemia (Intralipid < 2000 mg/dL)Biotin (< 81.8 nmol/L or < 20ng/mL)Albumin <6.3 g/dLIgG < 7 g/dLIgA < 1.6 g/dLIgM < 1 g/dL | The assay is unaffected by:Icterus (bilirubin < 701 µmol/Lor < 41 mg/dL)Hemolysis (Hb < 1.2 mmol/L or< 2 g/dL)Lipemia (Intralipid < 2000mg/dL)Biotin (< 409 nmol/L or < 100ng/mL)IgG < 7 g/dLIgM < 2 g/dL. |
| Characteristic | CalSet for Elecsys FT4 II Assay | Predicate Device: Elecsys FT4 Assay (K961489) |
| Intended Use | Elecsys FT4 II CalSet is used for calibrating the quantitative Elecsys FT4 II assay on the Elecsys and cobas e immunoassay analyzers. | Same |
| Levels | Two | Same |
| Matrix | Buffer/protein (bovine serum albumin) matrix | Same |
| Format | Liquid | Same |
| Stability | Unopened:• Store at 2 - 8°C up to the stated expiration date.After opening/in aliquots:• At 2 - 8°C: 12 weeks• On Elecsys 2010/cobas e 411 at 20°C: Up to 5 hours.• On MODULAR ANALYTICS E170/cobas e 601 and cobas e 602: Use only once. | Same |
| Handling | The calibrators are supplied ready-for -use in bottles compatible with the system | Same |
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510(k) Summary, continued ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
Comparison of Assays-Similarities and Differences, continued
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510(k) Summary, continued
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| Standard/GuidanceDocumentReference | In addition to FDA guidance regarding 510(k) submissions, the followingstandards were used for the performance studies.Evaluation of Precision Performance of Quantitative MeasurementMethods; Approved Guideline – Second Edition. CLSI documentEP5-A2, Volume 24, No. 25, August 2004. Evaluation of Detection Capability for Clinical LaboratoryMeasurement Procedures; Approved Guideline – Second Edition.CLSI document EP 17-A2, Volume 32, No. 8, June 2012. Evaluation of the Linearity of Quantitative MeasurementProcedures: A Statistical Approach; Approved Guideline. CLSIdocument EP6-A, Volume 23, No. 16, April 2003. Defining, Establishing, and Verifying Reference Intervals in theClinical Laboratory; Approved Guideline – Third Edition. CLSIdocument C28-A3c, Volume 28, No. 30, October 2010 (correctedversion). |
|---|---|
| PerformanceStudiesSummary | The Elecsys FT4 II Assay was evaluated for several performancecharacteristics, including precision, limit of blank, limit of detection, limitof quantitation, linearity, method comparison, interfering substances, andcalibration and reagent stability. There were no modifications to theElecsys FT4 II CalSet from the Elecsys FT4 CalSet other than the nameand catalog number.1. Precision (CLSI EP5-A2): The precision of the Elecsys FT4 II assaywas evaluated on one cobas e 411 Immunoassay Analyzer accordingto CLSI EP5-A2 guideline. Repeatability and Intermediate precisionwere calculated according to EP5-A2.The protocol consisted of testing 2 replicates of each human serumsample and control per run, two (2) runs per day (whereas the runswere divided by dummy samples) for 21 days.Specification for Repeatability/within-run precision:Concentrations of ≤ 0.4 ng/dL: SD ≤ 0.02 ng/dL Concentrations of > 0.4-7.77 ng/dL: CV ≤ 5% Specification for Intermediate/within-laboratory precision:Concentrations of ≤ 0.4 ng/dL: SD ≤ 0.03 ng/dL Concentrations of > 0.4-7.77 ng/dL: CV ≤ 8% |
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Performance Studies Summary, continued
The table below summarizes the results of the precision studies performed with the Elecsys FT4 II test system. Based on these data, the precision meets the specifications.
| Sample | Mean(ng/dL) | Repeatability | Intermediate Precision | n | ||||
|---|---|---|---|---|---|---|---|---|
| SD(ng/dL) | CV(%) | 95% UCL*(% orng/dL) | SD(ng/dL) | CV(%) | 95% UCL*(% orng/dL) | |||
| PCU 1 | 1.22 | 0.011 | 0.9 | 1.1 | 0.022 | 1.8 | 2.4 | 84 |
| PCU 2 | 3.11 | 0.032 | 1.0 | 1.3 | 0.089 | 2.9 | 3.9 | 84 |
| HS 1 | 0.138 | 0.006 | 4.0 | 0.007ng/dL | 0.011 | 7.6 | 0.014ng/dL | 84 |
| HS 2 | 1.03 | 0.013 | 1.3 | 1.6 | 0.023 | 2.3 | 2.9 | 84 |
| HS 3 | 1.90 | 0.024 | 1.3 | 1.6 | 0.040 | 2.1 | 2.8 | 84 |
| HS 4 | 4.93 | 0.082 | 1.7 | 2.1 | 0.163 | 3.3 | 4.4 | 84 |
| HS 5 | 7.09 | 0.127 | 1.8 | 2.3 | 0.319 | 4.5 | 6.2 | 84 |
- Upper confidence limit
-
- Limit of Blank (LoB) (CLSI EP17-A2): LoB of the Elecsys FT4 II assay on two cobas e 411 Immunoassay Analyzers has been determined according to CLSI EP17-A2 using three reagent lots.
The distribution of values for one analyte-free human serum sample has been determined on two cobas e 411 Immunoassay Analyzers over four days, one or two runs per day with five-fold determination in each run: (total 60 determinations).
- Limit of Blank (LoB) (CLSI EP17-A2): LoB of the Elecsys FT4 II assay on two cobas e 411 Immunoassay Analyzers has been determined according to CLSI EP17-A2 using three reagent lots.
Since there are no natural human samples without FT4 analyte, the analyte-free sample was created by depleting T4. As the analyzers do not report negative sample concentrations, the data set is truncated and the data were evaluated according to EP17-A2. 5.3.3.1 as the linear interpolation of the 57th and 58th ranked observation.
The LoB claim in the package insert will be set to ≤ 0.03 ng/dL.
-
- Limit of Detection (LoD) (CLSI EP17-A2): LoD of the Elecsys FT4 II assay has been determined according to CLSI EP17-A2, 5.3.3.2.
The distribution of values for five low-level human serum samples has been determined on two cobas e 411 immunoassay analyzers over four days, one or two runs per day with a single measurement per run.
- Limit of Detection (LoD) (CLSI EP17-A2): LoD of the Elecsys FT4 II assay has been determined according to CLSI EP17-A2, 5.3.3.2.
A pooled estimate of the precision (SDota) for the 5 low level samples was calculated: LoD = LoB + 1.653 x SD total (of low analyte samples)
The LoD claim in the package insert will be set to ≤ 0.05 ng/dL.
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- LoQ / Functional Sensitivity (CLSI EP17-A2): The LoQ of the Elecsys FT4 II assay was determined on the cobas e 411 immunoassay analyzer according to CLSI Guideline EP17-A2.
A Low-Level Sample Set of 8 samples was prepared by diluting native human serum samples with an analyte-free human serum matrix and were tested in single replicates for four days, one or two runs per day on two cobas e 411 immunoassay analyzers. Each run was calibrated separately using a two-point calibration in combination with the master curve stored on the reagent barcode. The Elecsys PreciControl Universal was tested and evaluated for each run to determine assay validity.
The mean, standard deviation and coefficient of variation for each sample were calculated. Functional sensitivity as the concentration corresponding to a coefficient of variation of 20% was obtained from plotting the %CV (y-axis) vs. measured FT4 values (x-axis).
Acceptance criterion:
- Interassay coefficient of variation ≤ 20% .
The Limit of Quantitation/Functional sensitivity claim in the package insert will be set to 0.1 ng/dL.
The following results were obtained:
| Lot MP02: | Functional sensitivity = 0.059 ng/dL |
|---|---|
| Lot P2: | Functional sensitivity = 0.069 ng/dL |
| Lot P3: | Functional sensitivity = 0.080 ng/dL |
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510(k) Summary, continued
- Linearity (CLSI EP6-A): Linearity of the Elecsys FT4 II assay was Performance assessed on the cobas e 411 Immunoassay Analyzer according to CLSI Studies Summary, EP6-A. continued Three high analyte serum sample pools (spiked with L-Thyroxine) were diluted with fT4 depleted human serum. For each sample pool, 13 concentrations (11 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. In the first step, a linearity check was performed with a first order (linear) regression and then with higher order models (quadratic and cubic). Acceptance criteria: Significance level for deviation to higher order polynomial: 5% Limits for deviation of higher order polynomial regression: 0.1 - 0.388 ng/dL: -±0.078 ng/dL . > 0.388 -- 7.77 ng/dL: ± 10% Repeatability for linearity: ±0.039 ng/dL 0.1 - 0.388 ng/dL: . ± 5 % > 0.388 - 7.77 ng/dL: . Linearity was confirmed in the range from 0.096 to 8.20 ng/dL 6. Specificity/Cross Reactivity: The specificity of the Elecsys FT4 II assay was determined using native human serum samples or human serum samples spiked with L-Thyroxine (single donors) spiked with potential cross-reactant compounds tested in duplicate on cobas e 411 Immunoassay Analyzer. In the labeling. Roche will report the maximum cross-reactivity found and the highest concentration tested. See table below.
| Cross Reactant | Cross Reactivity (%) |
|---|---|
| L-T3 | ≤ 0.005 |
| D-T3 | ≤ 0.001 |
| rT3 | ≤ 0.003 |
| 3-iodo-L-trosine | ≤ 0.000 |
| 3,5-diiodo-L-tyrosine | ≤ 0.000 |
| 3,3',5-triiodohyroacetic acid | ≤ 0.000 |
| 3,3',5,5'-tetraiodothyroacetic acid | ≤ 0.001 |
Continued on next page
CONFIDENTIAL
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- Exogenous Interferences - Drugs: 17 pharmaceutical compounds Performance (concentration defined as x times the maximum daily dose according Studies to the SOP) and 12 thyroid drugs and Furosemide were spiked into Summary, human serum samples (human serum pools spiked with L-Thyroxine) continued and tested with the Elecsys FT4 II assay on the cobas e 411 Immunoassay Analyzer. Two samples with approximately1.1 ng/dL and 2.6 ng/dL of fT4 were divided into aliquots and spiked with potential interferents. The reference sample, without interferents, was spiked with the respective amount of solvent only. The fT4 concentration of the spiked aliquots was determined in triplicate and compared to the fT4 concentration determined for the reference aliquot (6-fold determination) on one cobas e 411 Immunoassay Analyzer. Acceptance criterion: 100 ± 10% of the reference value (unspiked sample) Each compound, except Levothyroxine and Furosemide, was found to be non-interfering at the concentration listed below. Levothyroxine and Furosemide will be listed as interfering substances in the "Limitations - Interference" section of the package insert. 8. Exogenous Interferences - Anticoagulants: The effect on quantitation of analyte in the presence of anticoagulants with the Elecsys FT4 II Immunoassay was determined by comparing values obtained from native samples or samples spiked with L-Thyroxine (single donors) drawn into serum, Li-Heparin, K2-EDTA-, and K3-EDTA-plasma primary tubes, and Li-Heparin Plasma Separation Tubes. Between 53 and 63 serum/plasma pairs per sample material were tested in single determination with one reagent lot on one cobas e 411 Immunoassay Analyzer. Potential effects are assessed by Passing/Bablok regression and linear regression analysis. Acceptance criteria: . Slope 0.9 - 1.1 Intercept < ± 0.05 ng/dL Coefficient of correlation r ≥ 0.95 . Continued on next page
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510(k) Summary, continued
| PerformanceStudiesSummary,continued | Acceptance criterion for single pairs:• LoD < 0.3 ng/dL: ± 0.05 ng/dL• ≥ 0.3 - 7.77 ng/dL: ± 10 % of reference valueConclusion: The specifications were met for all anti-coagulants. Theresulting data support the package insert claim that serum, Li-Heparin,K2-EDTA-, and K3-EDTA-plasma specimens are acceptable sampletypes for use with the Elecsys FT4 II Immunoassay. | |
|---|---|---|
| 9. Endogenous Interferences: Effect on quantitation of analyte in thepresence of endogenous interfering substances using the Elecsys FT4II Immunoassay was determined on the cobas e 411 ImmunoassayAnalyzer using pooled human serum samples spiked with L-Thyroxine. For each interfering substance, 3 serum samples containinglow, mid, and high concentrations of fT4 were tested. | Acceptance criterion: Recovery of 100 ± 10% of unspiked referencevalue. | |
| The assay is unaffected by icterus (bilirubin < 701 µmol/L or < 41mg/dL), hemolysis (Hb < 0.621 mmol/L or < 1.0 g/dL), lipemia(Intralipid < 2000 mg/dL), biotin (< 81.8 nmol/L or < 20 ng/mL),Albumin <6.3 g/dL, IgG < 7 g/dL, IgA < 1.6 g/dL and IgM < 1 g/dL. | ||
| 10. Method Comparison: A method comparison study was performed tocompare the FT4 II assay on the cobas e 411 (Y) with the FT4 assayon the cobas e 411 (X) Immunoassay Analyzer (predicate test system). | ||
| A total of 170 human serum samples obtained from serum fromcommercial vendors or remnant clinical samples with fT4 values from0.161 - 7.05 ng/dL were measured. Out of the 170 serum samples, 11samples were spiked with analyte and 4 samples were diluted with anFT4 free serum. The results were calculated using the Passing/Bablokand Linear Regression analysis. | ||
| Acceptance criteria for Passing/Bablok regression:Slope: 1.00 ± 0.05Intercept: ± 0.04 ng/dLCorrelation: r ≥ 0.95Bias at medical decision points: ±10% at 0.93 ng/dL±10% at 1.7 ng/dL | ||
| PerformanceStudiesSummary,continued | 11. Calibration Stability: Calibration of an Elecsys FT4 II reagent lot isrecommended every 28 days. During that time period, fresh reagentkits of the same lot can be used without calibration by using thecalibration curve of the Day 0 reagent kit. | |
| Elecsys FT4 II was calibrated with a fresh reagent kit on Day 0 using acobas e 411 Immunoassay Analyzer. After 29 days, a new reagent kitof the same lot was used and recovery of samples was determinedusing the calibration curve of Day 0. Samples tested included fivehuman serum (HS) samples spiked with L-Thyroxine and two controls.Each sample was tested in duplicate. | ||
| Acceptance criteria for recovery compared to day 0 value:Concentrations of LoD - 0.3 ng/dL:± 0.05 ng/dL> 0.3 – 7.77 ng/dL:100 ± 10 % | ||
| Renewed calibration is recommended as follows:After 1 month (28 days) when using the same reagent lot.●After 7 days (when using the same reagent kit on the analyzer).As required: e.g. quality control findings outside the specified●limits | ||
| 12. Reagent On-Board Stability: Elecsys FT4 II reagent kits can bestored on board of the analyzers for up to 28 days and for 56 days whenstored alternatively in the refrigerator and on the analyzer, with thetotal time on the analyzer not exceeding 120 hours. A new calibrationof the kit kept on-board is recommended every 7 days. | ||
| Acceptance criteria for recovery of samples compared to day 1:Concentrations from LoD to 0.3 ng/dL: ± 0.05 ng/dLConcentration of >0.3 to 7.77 ng/dL:100±10% | ||
| 13. Reagent Accelerated Stability: Elecsys FT4 II reagent kits have ashelf life of ≥ 12 months when stored at 2-8°C. | ||
| Accelerated reagent stability to estimate real time stability for theElecsys FT4 II assay was tested on one cobas e 411 ImmunoassayAnalyzer. | ||
| A kit was stored at 35℃ for 3 weeks and recovery of human samplesand controls were tested compared to a fresh kit stored at 2-8 ℃. | ||
| PerformanceStudiesSummary,continued | Samples tested included five human serum (HS) samples spiked withL-Thyroxine, and two controls. Each sample was tested in two-folddetermination. | |
| Acceptance criteria for recovery of samples compared to day 0: | ||
| • Concentrations from LoD to 0.3 ng/dL: | $\pm$ 0.05 ng/dL | |
| • Concentration of >0.3 to 7.77 ng/dL: | 100 $\pm$ 10% | |
| 14. Reagent Real-Time Stability: In the ongoing real-time stabilitystudy, the Elecsys FT4 II assay material is stored at 2-8°C. The storedassay reagents are tested at time point T=0 and at specified intervalsover the shelf life of the device up to the planned shelf life plus one |
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CONFIDENTIAL
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510(k) Summary, continued
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Continued on next page
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510(k) Summary, continued
1 and PreciControl Universal 2 (Stored at -20°C).
Data for the time-points at 0, 7, 10, 13, 16, 19 and 25 months tested in duplicate will be available. The average on-test recovery value will be calculated as percent recovery compared to the reference value (Assigned value for PreciControl Universal 1 and PreciControl Universal 2).
month. Testing was/will be performed using PreciControl Universal
The acceptance criterion is recovery of 90-110% of the reference value.
Currently. the shelf life claim is 12 months based on the accelerated stability results and real-time stability data. The testing will continue with this stability protocol until data to support a claim of 24 months is achieved.
15. Reagent Stability after first opening (2-8°C): Elecsys FT4 II reagent kits can be used after first opening for up to 84 days (12 weeks) when stored at 2-8ºC.
Reagent stability after first opening for the Elecsys FT4 II assay was tested on one cobas e 411 Immunoassay Analyzer with one reagent lot.
A fresh kit was placed on the analyzer and calibrated. Reference values for the samples tested were determined. After measurement, the kit was removed from the analyzer and kept at 2-8 °C for up to 85 days. After 29, 57 and 85 days, the kit was placed on the analyzer again, calibrated, and the test samples were determined.
Samples tested included five human serum (HS) samples spiked with L-Thyroxine, and two controls. Each sample was tested in two-fold determination.
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Performance
Studies
Summary, continued
510(k) Summary, continued
| Acceptance criteria for recovery of samples compared to Day 0:Concentrations of: ≤ 0.3 ng/dL: ± 0.05 ng/dL> 0.3 - 7.77 ng/dL: 100 ± 10 % |
|---|
| Reagent stability after first opening for the Elecsys FT4 II assay wastested on one cobas e 411 Immunoassay Analyzer with one reagent lot.A fresh kit was placed on the analyzer and calibrated. Reference valuesfor the samples tested were determined. After measurement, the kit wasremoved from the analyzer and kept at 2-8 °C for up to 85 days. After29, 57 and 85 days, the kit was placed on the analyzer again, calibrated,and the test samples were determined. |
| Samples tested included five human serum (HS) samples spiked with L-Thyroxine, and two controls. Each sample was tested in two-folddetermination. |
| Acceptance criteria for recovery of samples compared to Day 0:Concentrations of: ≤ 0.3 ng/dL: ± 0.05 ng/dL> 0.3 - 7.77 ng/dL: 100 ± 10 % |
16. Reference Range Validation Study (CLSI C28-A3c): The Reference Range Validation Study was performed with 60 subjects (30 males and 30 females) with normal TSH values (0.270 - 4.20μIU/mL) as measured with the Elecsys TSH assay.
Results have been checked for outliers applying the method of Dixon/Reed as described in C28-A3c 9.2. (R = 11.1, D = 1/3 R = 3.7). All 60 determinations are valid and no outliers needed to be excluded.
Acceptance criterion: No more than 6 (10%) of the 60 tested subjects should fall outside of the established reference range of 0.93-1.7 ng/dL.
The FT4 values of 2 of the 60 subjects investigated fall outside of the reference range established for the Elecsys FT4 assay. The acceptance criterion is met. The reference range of 0.93-1.7 ng/dL can be transferred to the Elecsys FT4 II assay.
Conclusion
The data demonstrate that the performance of the Elecsys FT4 II Assay is substantially equivalent to that of the predicate device, Elecsys FT4 Assay (K961489).
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Image /page/17/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wing shapes, representing health, human services, and the public. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2014
ROCHE DIAGNOSTICS EDIE EADS REGULATORY AFFAIRS CONSULTANT 9115 HAGUE ROAD INDIANAPOLIS IN 46250-0416
Re: K131244
Trade/Device Name: Elecsys FT4 II Assay, Elecsys FT4 II CalSet Regulation Number: 21 CFR 862.1695 Regulation Name: Free thyroxine test system Regulatory Class: II Product Code: CEC, JIT Dated: December 13, 2013 Received: December 16, 2013
Dear Ms. 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. The general controls provisions of the Act include requirements for annual registration. Ilisting 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance 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. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.
Sincerely yours.
Courtney H. Lias -S
Courtney H. Lias, Ph.D. 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 Form
510(k) Number (if known):
Device Name: Elecsys FT4 II Assay, Elecsys FT4 II CalSet
Indications for Use:
The Elecsys FT4 II Assay is for the in vitro quantitative determination of free Thyroxine in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Elecsys FT4 II CalSet is used for calibrating the quantitative Elecsys FT4 II assay on the Elecsys and cobas e immunoassay analyzers.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) .
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung Dogan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K131244 210(k)
Page 1 of 1
§ 862.1695 Free thyroxine test system.
(a)
Identification. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II.