(86 days)
Elecsys Calcitonin Immunoassay:
The Calcitonin Immunoasay is intended for the in vitro quantitative determination of human calcitonin (thyrocalcitonin) in serum and plasma. The calcitonin determination is intended to be used as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism in conjunction with other clinical and laboratory findings.
Elecsys Calcitonin CalSet:
Calcitonin CalSet is used for calibrating the quantitative Elecsys Calcitonin assay on the Elecsys and cobas e immunoassay analyzers.
Elecsys Calcitonin CalCheck 5:
The Elecsys CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the calcitonin assay range established by the Elecsys and cobas e immunoassay analvzers.
Elecsys PreciControl Varia:
The Elecsys PreciControl Varia is used for quality control of the Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.
The Calcitonin Assay employs monoclonal antibodies specifically directed against hCT. The antibodies labeled with a ruthenium complex and biotin, respectively consist of mouse-specific components.
Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve (5-point-calibration) provided with the reagent bar code.
The Elecsys Calcitonin CalSet is a lyophilized product based on buffered equine serum. It has been standardized to IRP WHO Reference Standard 89/620.
The Elecsys Calcitonin CalCheck 5 is a lyophilized product based on buffered equine serum. It has been standardized to IRP WHO Reference Standard 89/620.
The PreciControl Varia is a multi-composite lyophilized 3 level control set which has been previously cleared (K111506), with added calcitonin analyte.
This document describes the specifications and comparative characteristics of the Elecsys Calcitonin Immunoassay and its associated calibrators and quality controls against predicate devices. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance (Elecsys Calcitonin Immunoassay vs. Predicate Device)
| Feature | Predicate Device: Immulite 1000 Calcitonin, Model LKCL (K023304) | Elecsys Calcitonin Immunoassay (New Device) |
|---|---|---|
| Intended Use | To measure calcitonin levels in serum for diagnosis and treatment of thyroid and parathyroid gland diseases. | Quantitative determination of human calcitonin in serum and plasma for diagnosis and treatment of thyroid and parathyroid gland diseases (including carcinoma and hyperparathyroidism) in conjunction with other clinical and laboratory findings. |
| Assay Protocol | Solid-phase, enzyme-labeled, two-site chemiluminescent immunometric assay; 2 x 30 minutes incubation, 60 minutes total duration. | Murine monoclonal antibodies (ruthenium complex and biotin labeled) directed against hCT. Streptavidin coated microparticles as solid phase. Sandwich principle. 18 minutes total duration. |
| Detection Protocol | Chemiluminescent Immunometric assay | Electrochemiluminescent Immunoassay |
| Instrument Platform | Immulite 1000 | cobas e 411 |
| Sample Volume | 75 µL | 50 µL |
| Sample Type | Human serum or heparinized plasma | Human serum and plasma treated with K2-EDTA, K3-EDTA, lithium heparin, and lithium heparin plasma gel separation tubes. |
| Calibrator | Siemens Calcitonin Adjustors (LCLL, LCLH) | Elecsys Calcitonin CalSet |
| Calibration Interval | Recommended: 4 weeks | Once per reagent lot (fresh reagent, <24 hours since registered on analyzer). Renewed: After 2 months (56 days) for same reagent lot; After 7 days for same reagent kit on analyzer; As required (e.g., QC outside limits). |
| Controls | Two levels (low and high) of calcitonin. | Elecsys PreciControl Varia |
| Traceability/Standardization | Standardized against WHO 2nd IRP 89/620 | Same (Standardized against WHO 2nd IRP 89/620) |
| Reagent Stability | Stable at 2-8°C until expiration date | Unopened: 2-8°C until expiration date. Opened: 2-8°C for 12 weeks. On Analyzers: 4 weeks. |
| Measuring Range | 0.6 - 2000 pg/mL | 1.0 - 2000 pg/mL |
| Precision (Within-run) | Sample 1: 22 pg/mL, 3.9% CVSample 2: 44 pg/mL, 3.0% CVSample 3: 145 pg/mL, 2.3% CVSample 4: 621 pg/mL, 2.2% CVSample 5: 1029 pg/mL, 2.4% CVSample 6: 1207 pg/mL, 2.3% CV | cobas e 411 (Repeatability):0.03 SD @ 1.21 pg/mL3.0% CV @ 11.5 pg/mL2.5% CV @ 48.5pg/mL2.9% CV @ 482 pg/mL2.2% CV @ 1910 pg/mL0.19 SDPCV1 @ 8.88 pg/mL1.5% CVPCV2 @ 97.7 pg/mL |
| Precision (Total/Intermediate) | Sample 1: 22 pg/mL, 11.4% CVSample 2: 44 pg/mL, 7.5% CVSample 3: 145 pg/mL, 7.5% CVSample 4: 621 pg/mL, 10.6% CVSample 5: 1029 pg/mL, 8.5% CVSample 6: 1207 pg/mL, 9.5% CV | (Intermediate):0.04 SD @ 1.21 pg/mL3.6% CV @ 11.5 pg/mL3.5% CV @ 48.5pg/mL4.0% CV @ 482 pg/mL3.4% CV @ 1910 pg/mL0.26 SDPCV1 @ 8.88 pg/mL2.6% CVPCV2 @ 97.7 pg/mL |
| Analytical Sensitivity | 2 pg/mL | Limit of Blank (LoB): 0.3 pg/mLLimit of Detection (LoD): 0.5 pg/mLLimit of Quantitation (LoQ): 1 pg/mL |
| Hook Effect | No high-dose hook effect up to 25,000 pg/mL. | No high-dose hook effect up to 1,000,000 pg/mL. |
| Limitations (Interference) | Hemoglobin < 550 mg/dL, Bilirubin < 200 mg/L, Lipemia < 3000 mg/dL. | Hemoglobin < 200 mg/dL, Bilirubin < 66 mg/dL, Lipemia < 2000 mg/dL, Biotin < 40 ng/mL, Rheumatoid factors < 1,200 IU/mL, IgG < 4 g/dL, IgM < 0.7 g/dL, IgA < 1.6 g/dL. No interference from 17 commonly used and 12 special pharmaceuticals. (Minimizes interference from extremely high titers of antibodies). |
| Method Comparison (Correlation) | n = 150 (Min = 2.04 pg/mL, Max = 1779 pg/mL)Passing/Bablok: Slope 1.01, Intercept -0.404, Tau/r 0.925Deming: Slope 0.998, Intercept -0.305, Tau/r 0.991 | Not explicitly stated as "acceptance criteria", but results are provided for comparison to predicate. |
| Clinical Reference Range (95th/97.5th percentile) | 95th percentile:Female 5.0 pg/mLMale 8.4 pg/mL | 97.5th percentile:Female 7.63 pg/mLMale 14.3 pg/mL |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison: n = 150 patient samples were used for the method comparison study against the predicate device.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective for the method comparison or other performance studies. However, the manufacturer is Roche Diagnostics, with establishment registrations in Germany and the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the given document. For an in vitro diagnostic device measuring a quantitative analyte like Calcitonin, "ground truth" is typically established by the reference method or by the predicate device's measured values, rather than by human expert review of images or clinical cases.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided for this type of in vitro diagnostic device. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretation, such as imaging studies, where multiple experts review and reconcile findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable and not mentioned for this in vitro diagnostic device. These studies are relevant for medical imaging AI where human readers interpret diagnostic images. The performance of this device is measured through analytical parameters like precision, sensitivity, and method comparison with a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This device is an in vitro diagnostic immunoassay, meaning its performance is inherently "standalone" in the sense that it analytically measures calcitonin levels. Its performance characteristics (precision, analytical sensitivity, measuring range, etc.) are determined directly by the assay and instrument without a human "in-the-loop" during the measurement process. The results are then interpreted by clinicians. The provided performance metrics (precision, analytical sensitivity, hook effect, method comparison, and interference studies) represent the standalone performance of the assay.
7. The Type of Ground Truth Used
- For the method comparison study, the predicate device's measurements (Immulite 1000 Calcitonin) served as the "ground truth" or reference for comparison. The new device's measurements were correlated against these values.
- For standardization and traceability, both the predicate and the new device were standardized against the WHO 2nd IRP 89/620 (International Reference Preparation) for calcitonin. This international standard effectively acts as the ultimate "ground truth" for calibrating and standardizing calcitonin measurements.
8. The Sample Size for the Training Set
- This document describes performance verification studies, not the development or "training" of an algorithm in the machine learning sense. Therefore, information on a "training set" sample size is not provided and not directly applicable to the described analytical performance studies of a chemical immunoassay.
9. How the Ground Truth for the Training Set Was Established
- As mentioned in point 8, the concept of a "training set" with ground truth in the context of an algorithm or AI is not directly applicable here. For the standardization of the Elecsys Calcitonin Immunoassay, it is stated that the device and its calibrators are standardized to the IRP WHO Reference Standard 89/620. This international reference standard defines the "ground truth" for calcitonin concentration for the purpose of accurate measurement and calibration.
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Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. Submitter Roche Diagnostics 9115 Hague Road Name, Address, P.O. Box 50416 DEC 0 4 2013 Indianapolis, IN 46250-0415 Contact Contact Person: Kelli Turner (Regulatory Affairs Principal) . Phone: (317) 521-4515 Fax: (317) 521-2324 o Email: kelli.turner@roche.com o Date Prepared: November 25, 2013 Device Name Proprietary name: (1) Elecsys Calcitonin Immunoassay (2) Elecsys Calcitonin CalSet (3) Elecsys Calcitonin CalCheck 5 (4) Elecsys PreciControl Varia Common name: (1) Calcitonin assay (2) Calcitonin CalSet (3) Calcitonin CalCheck 5 (4) PreciControl Varia Classification name: 1) Radioimmunoassay, Calcitonin 2) Calibrator, Secondary 3) Quality control material 4) Quality control material
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| Device Name,continued | Product Code: | 1) JKR2) JIT3) JJY4) JJY |
|---|---|---|
| Predicate Device: | 1) Assay: Siemens Immulite 1000 Calcitonin,Model LKCL (K023304)2) Calibrator: Elecsys Vitamin D CalSet (K113546)3) Control: Elecsys T4 CalCheck 5 (K112528)4) Control: Elecsys PreciControl Varia (K111506) | |
| EstablishmentRegistration | For the Elecsys Calcitonin test system, the establishment registrationnumber for Roche Diagnostics GmbH in Mannheim, Germany, is 9610126and for Penzberg, Germany, is 9610529. The establishment registrationnumber for Roche Diagnostics in the United States is 1823260 | |
| Classification | The FDA has classified the Radiometry, Calcitonin test system and theCalibrator, Secondary (Calcitonin CalSet) as a Class II device. The FDA hasclassified the multi-analyte controls, all kinds (assayed and unassayed) as aClass I device (Calcitonin CalCheck 5 and PreciControl Varia). |
| Panel | ProductCode | Classification Name | Regulation Citation |
|---|---|---|---|
| Clinical Chemistry | JKR | Radioimmunoassay,Calcitonin | 21 CFR 862.1140 |
| Clinical Chemistry | JIT | Calibrator, secondary | 21 CFR 862.1150 |
| Clinical Chemistry | JJY | Quality Control material | 21 CFR 862.1660 |
| Clinical Chemistry | JJY | Quality Control material | 21 CFR 862.1660 |
Analyzer Platform
For the analytical and clinical studies, the cobas e 411 was used as the master analyzer.
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continued
The Calcitonin Assay employs monoclonal antibodies specifically directed Device against hCT. The antibodies labeled with a ruthenium complex and biotin, Description respectively consist of mouse-specific components.
Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve (5-point-calibration) provided with the reagent bar code.
The Elecsys Calcitonin CalSet is a lyophilized product based on buffered equine serum. It has been standardized to IRP WHO Reference Standard 89/620.
The Elecsys Calcitonin CalCheck 5 is a lyophilized product based on buffered equine serum. It has been standardized to IRP WHO Reference Standard 89/620.
The PreciControl Varia is a multi-composite lyophilized 3 level control set which has been previously cleared (K111506), with added calcitonin analyte.
| IntendedUse/Indicationsfor Use | Elecsys Calcitonin Reagent:• The Calcitonin immunoassay is intended for the in vitro quantitativedetermination of human calcitonin (thyrocalcitonin) in serum andplasma. The calcitonin determination is intended to be used as an aidin the diagnosis and treatment of diseases involving the thyroid andparathyroid glands, including carcinoma and hyperparathyroidism inconjunction with other clinical and laboratory findings.The electrochemiluminescence immunoassay “ECLIA” is intendedfor use on the indicated Elecsys and cobas e immunoassay analyzers. |
|---|---|
| Elecsys Calcitonin CalSet:• Calcitonin CalSet is used for calibrating the quantitative ElecsysCalcitonin assay on the Elecsys and cobas e immunoassay analyzers | |
| Elecsys Calcitonin CalCheck 5:• The Elecsys Calcitonin CalCheck 5 is an assayed control for use incalcitonin calibration verification and for use in the verification ofthe calcitonin assay range established by the Elecsys and cobas eimmunoassay analyzers. | |
| Elecsys PreciControl Varia:• The Elecsys PreciControl Varia is used for quality control of theElecsys immunoassays on Elecsys and cobas e immunoassayanalyzers. |
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510(k) Summary for Calcitonin test system, continued
Substantial The Elecsys Calcitonin Test System is substantially equivalent to other devices legally marketed in the United States. Equivalence
The Elecsys Calcitonin immunoassay is equivalent to Immulite 1000 Calcitonin (K023304).
Elecsys Calcitonin CalSet is equivalent to Elecsys Vitamin D CalSet (K113546).
Elecsys Calcitonin CalCheck 5 is equivalent to the Elecsys T4 CalCheck 5 (K112528).
Elecsys PreciControl Varia is equivalent to Elecsys PreciControl Varia (K111506).
Substantial Equivalence -Comparison
The following tables compare:
- . The Elecsys Calcitonin Immunoassay with its predicate device (K023304).
- . The Calcitonin CalSet with its predicate device (K113546).
- The Calcitonin CalCheck 5 its the predicate device (K112528). .
- PreciControl Varia to its predicate device (K111506). .
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Comparison of Assays, Similarities and Differences
Table 1
| Assay Comparison | ||
|---|---|---|
| Feature | Predicate Device: Immulite 1000Calcitonin, Model LKCL (K023304) | Elecsys Calcitonin Immunoassay |
| IntendedUse/Indicationsfor Use | Intended to measure the thyroidhormone calcitonin (thryocalcitonin)levels in serum. Calcitoninmeasurements are used in thediagnosis and treatment of diseasesinvolving the thyroid and parathyroidglands, including carcinoma andhyperparathyroidism (excessiveactivity of the parathyroid gland). | The Calcitonin immunoassay isintended for the in vitro quantitativedetermination of human calcitonin(thyrocalcitonin) in serum and plasma.The calcitonin determination isintended to be used as an aid in thediagnosis and treatment of diseasesinvolving the thyroid and parathyroidglands, including carcinoma andhyperparathyroidism in conjunctionwith other clinical and laboratoryfindings.The electrochemiluminescenceimmunoassay "ECLIA" is intendedfor use on the indicated Elecsys andcobas e immunoassay analyzers. |
| AssayProtocol | A solid-phase, enzyme-labeled, two-site chemiluminescent immunometricassay. The solid-phase, a polystyrenebead enclosed within an IMMULITE1000 Test Unit, is coated with amonoclonal murine antibody specificfor calcitonin.Incubation cycles: 2 x 30 minutesTotal duration of assay: 60 minutes. | Assay employs murine monoclonalantibodies specifically directed againsthCT. One antibody is labeled withruthenium complex; the secondantibody is labeled with Biotin.Streptavidin coated microparticles areused as solid phase.Sandwich principle. Total duration ofassay: 18 minutes |
| DetectionProtocol | Chemiluminescent Immunometricassay | ElectrochemiluminescentImmunoassay |
| Applications | 60-minute application | 18-minute application |
| Assay Comparison | ||
| Feature | Predicate Device: Immulite 1000Calcitonin, Model LKCL (K023304) | Elecsys Calcitonin Immunoassay |
| General Assay Features | ||
| InstrumentPlatform | Immulite 1000 | cobas e 411 |
| SampleVolume | 75 µL | 50 µL |
| SampleType | Human serum or heparinized plasma | Human serum and plasma treated withK2-EDTA, K3-EDTA, lithium heparinand lithium heparin plasma gelseparation tubes. |
| Reagents | A solid-phase, enzyme-labeled, two-site chemiluminescent immunometricassay. The solid-phase, a polystyrenebead enclosed within an IMMULITE1000 Test Unit, is coated with amonoclonal murine antibody specificfor calcitonin.Incubation cycles: 2 x 30 minutesTotal duration of assay: 60 minutes. | Sandwich principle. Total duration ofassay: 18 minutesAssay employs murine monoclonalantibodies specifically directed againsthCT. One antibody is labeled withruthenium complex; the secondantibody is labeled with Biotin.Streptavidin coated microparticles areused as solid phase. |
| Calibrator | Siemens Calcitonin Adjustors (LCLL,LCLH) | Elecsys Calcitonin CalSet |
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Comparison of Assays-Similarities and Differences, continued
Table 1 continued
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510(k) Summary for Elecsys Calcitonin, continued
Comparison of Assays-Similarities and Differences, continued
Table 1 continued
| Assay Comparison | ||
|---|---|---|
| Feature | Predicate Device: Immulite 1000Calcitonin, Model LKCL(K023304) | Elecsys Calcitonin Immunoassay |
| General Assay Features | ||
| CalibrationInterval | Recommended Adjustment interval:4 weeks | Calibration must be performed onceper reagent lot using fresh reagent (i.e.not more than 24 hours since thereagent kit was registered on theanalyzer). Renewed calibration isrecommended as follows:cobas e 411 analyzers:After 2 months (56 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 |
| Controls | Use controls or sample pools with atleast two levels (low and high) ofcalcitonin. | Elecsys PreciControl Varia |
| Traceability /Standardization | Standardized against WHO 2nd IRP89/620 | Same |
| ReagentStability | Stable at 2-8°C until expiration date | Unopened:2-8°C - Up to the stated expirationdateOpened 2-8°C - 12 weeksOn Analyzers - 4 weeks |
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510(k) Summary for Elecsys Calcitonin, continued
Comparison of Assays-Similarities and Differences, continued
Table 1 continued
| Assay Comparison | |||||
|---|---|---|---|---|---|
| Feature | Predicate Device: Immulite 1000Calcitonin, Model LKCL (K023304) | Elecsys Calcitonin Immunoassay | |||
| Labeled Performance Characteristics | |||||
| MeasuringRange | 0.6 - 2000 pg/mL | 1.0 - 2000 pg/mL | |||
| Precision | Within-runSample | Mean | SD | CV | cobas e 411:Within-run (will be labeled Repeatability) |
| 1 | 22 | 0.86 | 3.9% | 0.03 SD @ 1.21 pg/mL | |
| 2 | 44 | 1.3 | 3.0% | 3.0% CV @ 11.5 pg/mL | |
| 3 | 145 | 3.3 | 2.3% | 2.5% CV @ 48.5pg/mL | |
| 4 | 621 | 13.8 | 2.2% | 2.9% CV @ 482 pg/mL | |
| 5 | 1029 | 24.8 | 2.4% | 2.2% CV @ 1910 pg/mL | |
| 6 | 1207 | 27.4 | 2.3% | 0.19 SDPCV1 @ 8.88 pg/mL1.5% CVPCV2 @ 97.7 pg/mL | |
| TotalSample | Mean | SD | CV | Total (will be labeled Intermediate) | |
| 1 | 22 | 2.5 | 11.4% | 0.04 SD @ 1.21 pg/mL | |
| 2 | 44 | 3.3 | 7.5% | 3.6% CV @ 11.5 pg/mL | |
| 3 | 145 | 10.9 | 7.5% | 3.5% CV @ 48.5pg/mL | |
| 4 | 621 | 65.6 | 10.6% | 4.0% CV @ 482 pg/mL | |
| 5 | 1029 | 87.3 | 8.5% | 3.4% CV @ 1910 pg/mL | |
| 6 | 1207 | 115 | 9.5% | 0.26 SDPCV1 @ 8.88 pg/mL2.6% CVPCV2 @ 97.7 pg/mL |
PCV2=PreciControl Varia level 2
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Comparison of Assays-Similarities and Differences, continued
Table 1 continued
| Assay Comparison | ||
|---|---|---|
| Feature | Predicate Device: Immulite 1000Calcitonin, Model LKCL (K023304) | Elecsys Calcitonin Immunoassay |
| Labeled Performance Characteristics | ||
| AnalyticalSensitivity | 2 pg/mL | Limit of Blank (LoB): = 0.3 pg/mLLimit of Detection (LoD): = 0.5pg/mLLimit of Quantitation (LoQ): = 1pg/mL |
| Hook Effect | There is no high-dose hook effect atconcentrations up to 25,000 pg/mL. | There is no high-dose hook effect atconcentrations up to 1,000,000 pg/mL. |
| Limitations | The assay is unaffected by the presence of:● Hemoglobin < 550 mg/dL.● Bilirubin < 200 mg/L● Lipemia < 3000 mg/dL | The assay is unaffected by:● Hemoglobin < 200 mg/dL.● Bilirubin < 66 mg/dL● Lipemia < 2000 mg/dL● Biotin < 40 ng/mL● Rheumatoid factors < 1,200 IU/mL● IgG < 4 g/dL● IgM < 0.7 g/dL● IgA < 1.6 g/dLIn vitro tests were performed on 17commonly used and 12 specialpharmaceuticals. No interference withthe assay was found.In rare cases, interference due toextremely high titers of antibodies toanalyte-specific antibodies, streptavidinor ruthenium can occur. These effectsare minimized by suitable test design. |
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Comparison of Assays-Similarities and Differences, continued
Table 1 continued
| Immunoassay Comparison | |||
|---|---|---|---|
| Feature | Predicate Device: Immulite 1000Calcitonin, Model LKCL (K023304) | Elecsys Calcitonin Immunoassay | |
| Labeled Performance Characteristics | |||
| MethodComparison | n = 150Min = 2.04 pg/mLMax = 1779 pg/mL | ||
| Passing/Bablok | Deming | ||
| SlopeInterceptTau/r | 1.01-0.4040.925 | 0.998-0.3050.991 | |
| ClinicalStudy/referencerange | 95th percentile:Female 5.0 pg/mLMale 8.4 pg/mL | 97.5th percentile:Female 7.63 pg/mLMale 14.3 pg/mL |
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Comparison of Assays-Similarities and Differences, continued
Table 1 continued
| Elecsys Calcitonin Immunoassay on cobas e 411(master analyzer) | ||
|---|---|---|
| Analytic Specificity | ||
| Cross reactant | Max.concentration tested(ng/mL) | Highestcross-reactivityobserved (%) |
| Salmon Calcitonin | 200 | 0.017 |
| Porcine Calcitonin | 1000 | 0.007 |
| Chicken Calcitonin | 1000 | 0.005 |
| ACTH (1-39)human | 200 | 0.037 |
| C-Peptide | 80000 | 0.000 |
| Calcitonin GeneRelated Peptide | 2000 | 0.002 |
| PTH (1-84) | 300 | 0.013 |
| TSH | 2000 $ \mu $ IU/mL | 0.009 |
| Insulin | 67000 | 0.000 |
| Prolactin | 2000 | 0.001 |
| Gastrin I | 4000 | 0.001 |
| Elcatonin | 200000 | 0.000 |
| Katacalcin | 80000 | 0.000 |
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| Elecsys CalSet comparison | ||
|---|---|---|
| Feature | Predicate DeviceElecsys Vitamin D CalSet | Elecsys Calcitonin CalSet |
| Intended Use | Elecsys Vitamin D CalSet isused for calibrating thequantitative Elecsys Vitamin Dassay on the Elecsys and cobase immunoassay analyzers. | Calcitonin CalSet is used forcalibrating the quantitative ElecsysCalcitonin assay on the Elecsysand cobas e immunoassayanalyzers. |
| Levels | Two | Two |
| Matrix | Human serum | Buffered (50 mmol/L HEPES)equine serum |
| Format | Lyophilized | Lyophilized |
| Stability | Unopened: up to the statedexpiration dateAfter reconstituting:At 2-8°C - 120 hoursAt -20°C - 90 days (freeze onlyonce)On Elecsys 2010/cobas e 411 at20-25°C: up to 5 hoursOn MODULAR ANALYTICSE170/cobas e 601: Use onlyonce | Unopened: up to the statedexpiration dateAfter reconstituting:At 2-8°C – 72 hoursAt -20°C – 84 days (freeze onlyonce)At 20-25°C: up to 5 hours |
| Composition | Buffer: HEPES 50mMPreservative: Bronidox L 0.5% | Buffer: HEPES 50mMHuman Calcitonin (synthetic) |
Table 2
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| Table 3 | ||
|---|---|---|
| --------- | -- | -- |
ନ୍ଦର
: 上一篇:
| Elecsys CalCheck comparison | ||
|---|---|---|
| Characteristic | Elecsys T4 CalCheck 5(Predicate Device) | Elecsys Calcitonin CalCheck 5 |
| Intended Use | The Elecsys T4 CalCheck 5is an assayed control foruse in calibrationverification and for use inthe verification of the assayrange established by theElecsys T4 quantitativeassay reagent on theindicated Elecsys andcobas e immunoassayanalyzers. | The Elecsys Calcitonin CalCheck 5 isan assayed control for use incalcitonin calibration verification andfor use in the verification of thecalcitonin assay range established bythe Elecsys and cobas e immunoassayanalyzers. |
| Analyte | T4 | Calcitonin |
| Levels | Five | Five |
| AssayMeasuringRange | 0.300 - 10.0 nmol/L | 1.0 - 2000 pg/mL |
| Check TargetValues | Check 1: ≤ 10 nmol/LCheck 2: 100 nmol/LCheck 3: 160 nmol/LCheck 4: 250 nmol/LCheck 5: 320 nmol/L | Check 1: ≤ 1.00 pg/mLCheck 2: 50 pg/mLCheck 3: 500 pg/mLCheck 4: 1000 pg/mLCheck 5: 2000 pg/mL |
| Format | Lyophilized | Same |
| Handling | Reconstitute Check 1,Check 2, Check 3, Check 4,and Check 5 with exactly1.0 mL distilled ordeionized water. Allow tostand closed for 15 minutes,then mix gently byinversion. | Same |
| Stability | Unopened:Store at 2-8°C untilexpiration dateReconstituted:15-25°C: 4 hours | Unopened:Store at 2-8°C until expirationdateReconstituted:20-25°C: 4 hours |
| Matrix | Level 1: BSA/Buffer matrixLevel 2-5: Human serum | Buffered (50 mmol/L HEPES) equineserum |
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Premarket Notification, 510(k) for the Elecsys Calcitonin test system, continued
| Elecsys PreciControl Varia comparison | ||
|---|---|---|
| Feature | Predicate DeviceElecsys PreciControl Varia(K111506) | Elecsys PreciControl Varia |
| Intended Use | Elecsys PreciControl Varia is usedfor quality control of specifiedElecsys immunoassays on theElecsys and cobas e immunoassayanalyzers. | Same with the addition of calcitoninanalyte. |
| Analyzer system | Elecsys and cobas eimmunoassay analyzers. | Same |
| Format | Lyophilized | Same |
| Levels | Three | Same |
| Matrix | Human serum | Same |
| Format | Lyophilized | Same |
| Traceability | • β-CrossLaps/serum (β-CTx)-Gravimetry• Osteocalcin-In-housereference system (commerciallyavailable osteocalcinimmuno/radio-binding assay• Parathyroid Hormone (PTHand PTH STAT)-In-housereference system (commerciallyavailable PTH radiobindingassay)• Vitamin B12-Commerciallyavailable radio-binding assay• Ferritin-NIBSC Standard80/602• Folate-Elecsys Folate IIAssay• Vitamin D -LC-MS/MS(which in turn has beenstandardized to the NISTstandard) | • β-CrossLaps/serum (β-CTx)-Gravimetry• Osteocalcin-In-house referencesystem (commercially availableosteocalcin immuno/radio-bindingassay• Parathyroid Hormone (PTH andPTH STAT)-In-house referencesystem (commercially availablePTH radiobindingassay)• Vitamin B12-Commerciallyavailable radio-binding assay• Ferritin-NIBSC Standard80/602• Folate-Elecsys Folate II Assay• Vitamin D -LC-MS/MS (whichin turn has been standardized tothe NIST standard)• Calcitonin- standardized to IRPWHO Reference Standard 89/620 |
| Elecsys PreciControl Varia comparison, continued | ||
| Feature | Predicate DeviceElecsys PreciControl Varia | Elecsys PreciControl Varia |
| Analyte | · Ferritin (ng/mL) | · Ferritin (ng/mL) |
| Concentration | Level 0 = 14 | Level 0 = 14 |
| Level 1 = 150 | Level 1 = 150 | |
| Level 2 = 1000 | Level 2 = 1000 | |
| · Folate (ng/mL) | · Folate (ng/mL) | |
| Level 0 = N/A | Level 0 = N/A | |
| Level 1 = 3.9 | Level 1 = 3.9 | |
| Level 2 = 12 | Level 2 = 12 | |
| · Vitamin B12 (pg/mL) | · Vitamin B12 (pg/mL) | |
| Level 0 = 230 | Level 0 = 230 | |
| Level 1 = 500 | Level 1 = 500 | |
| Level 2 = 1000 | Level 2 = 1000 | |
| · B-CTx (pg/mL) | · B-CTx (pg/mL) | |
| Level 0 = N/A | Level 0 = N/A | |
| Level 1 = 320 | Level 1 = 320 | |
| Level 2 = 750 | Level 2 = 750 | |
| · Osteocalcin (ng/mL) | · Osteocalcin (ng/mL) | |
| Level 0 = N/A | Level 0 = N/A | |
| Level 1 = 20 | Level 1 = 20 | |
| Level 2 = 100 | Level 2 = 100 | |
| · PTH and PTH STAT (pg/mL) | · PTH and PTH STAT (pg/mL) | |
| Level 0 = 25 | Level 0 = 25 | |
| Level 1 = 60 | Level 1 = 60 | |
| Level 2 = 200 | Level 2 = 200 | |
| · Vitamin D (ng/mL) | · Vitamin D (ng/mL) | |
| Level 0 = 12.8 | Level 0 = 12.8 | |
| Level 1 = 17 | Level 1 = 17 | |
| Level 2 = 32 | Level 2 = 32 | |
| · Calcitonin (pg/mL) | ||
| Level 0 = N/A | ||
| Level 1 = 10 | ||
| Level 2 = 100 |
{14}------------------------------------------------
Premarket Notification, 510(k) for the Elecsys Calcitonin test system, continued
Table 4, continued
. •
{15}------------------------------------------------
Premarket Notification, 510(k) for the Elecsys Calcitonin test system, continued
| Elecsys PreciControl Varia comparison, continued | ||
|---|---|---|
| Feature | Predicate DeviceElecsys PreciControl Varia | Elecsys PreciControl Varia |
| Handling | Dissolve carefully the contentsof one bottle by adding exactly3.0 mL of distilled or deionizedwater and allow standing closedfor 30 minutes to reconstitute.Mix carefully, avoiding theformation of foam. | Same |
| Volume(reconstituted) | 3.0 mL | Same |
| Stability | Unopened at 2 – 8 °C:up to the stated expiration dateReconstituted/thawed serum:• at – 20 °C: 31 days (freezeonlyonce)• at 2 – 8 °C: 72 hours• at 20 – 25 °C on-board theanalyzers: up to 5 hours | Same |
Table 4, continued
{16}------------------------------------------------
and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contraction of the con
| Standard/GuidanceDocumentReference | In addition to FDA guidance regarding 510(k) submissions, the followingstandards were used for the performance studies. |
|---|---|
| • Evaluation of Precision Performance of QuantitativeMeasurement Methods; Approved Guideline - Second Edition.CLSI document EP5-A2, Volume 24, No. 25, August 2004. | |
| • Protocols for Determination of Limits of Detection and Limits ofQuantitation; Approved Guideline. CLSI document EP 17-A,Volume 24, No. 34, October 2004. | |
| • Evaluation of Detection Capability for Clinical LaboratoryMeasurement Procedures; Approved Guideline- Second Edition.CLSI document EP17-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. | |
| • Method Comparison and Bias Estimation Using Patient Samples;Approved Guideline; Approved Guideline. CLSI document EP-09-A2-IR, Volume 22, No. 19, September 2002 |
Conclusion Statement
.
: .
י
The submitted information in this premarket notification supports a substantial equivalence decision.
{17}------------------------------------------------
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 4, 2013
ROCHE DIAGNOSTICS KELLI TURNER REGULATORY AFFAIRS PRINCIPAL 9115 HAGUE ROAD INDIANAPOLIS IN 46250-0416
Re: K132828 Trade/Device Name: Elecsys Calcitonin Immunoassay Elecsys Calcitonin CalSet Elecsys Calcitonin CalCheck 5 Elecsys PreciControl Varia Regulation Number: 21 CFR 862.1140 Regulation Name: Calcitonin test system Regulatory Class: II Product Codc: JKR, JIT, JJY Dated: September 17, 2013 Received: September 18, 2013
Dear Ms. Turner:
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
{18}------------------------------------------------
Page 2-Ms. Turner
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 regulations (2) 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 CDRF' 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/ResourcesforYou/Industry/default.htm.
Sincercly yours.
Carol C. Benson -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
{19}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Elecsys Calcitonin Immunoassay, Elecsys Calcitonin CalSet, Elecsys Calcitonin CalCheck 5, Elecsys PreciControl Varia
Indications for Use (Describe)
Elecsys Calcitonin Immunoassay:
The Calcitonin Immunoasay is intended for the in vitro quantitative determination of human calcitonin (thyrocalcitonin) in serum and plasma. The calcitonin determination is intended to be used as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism in conjunction with other clinical and laboratory findings.
Elecsys Calcitonin CalSet:
Calcitonin CalSet is used for calibrating the quantitative Elecsys Calcitonin assay on the Elecsys and cobas e immunoassay analyzers.
Elecsys Calcitonin CalCheck 5:
The Elecsys CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the calcitonin assay range established by the Elecsys and cobas e immunoassay analvzers.
Elecsys PreciControl Varia:
The Elecsys PreciControl Varia is used for quality control of the Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.
Type of Use (Select one or both, as applicable)
x Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FINA LISE | ||
|---|---|---|
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| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) |
FORM FDA 3881 (9/13)
§ 862.1140 Calcitonin test system.
(a)
Identification. A calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thyrocalcitonin) levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).(b)
Classification. Class II.