(236 days)
• Elecsys Vitamin D Reagent:
The Elecsys Vitamin D assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. The assay is to be used as an aid in the assessment of vitamin D sufficiency in adults.
The electrochemiluminescence binding assay is intended for use on Elecsys and cobas e immunoassay analyzers.
• Elecsys Vitamin D CalSet: Elecsys Vitamin D CalSet is used for calibrating the quantitative Elecsys Vitamin D assay on the Elecsys and cobas e immunoassay analyzers.
• Elecsys PreciControl Varia 3: Elecsys PreciControl Varia 3 is used for quality control of the specified Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers.
• Elecsys Vitamin D CalCheck 5: The Elecsys Vitamin D CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Vitamin D reagent on the indicated Elecsys and cobas e immunoassay analyzers.
(1) The Elecsys Vitamin D Assay is a competitive protein binding assay which uses Vitamin D Binding Protein instead of monoclonal antibodies for detection of 25-Hydroxyvitamin D. The total duration of the assay is 27 minutes. The sample is treated with pretreatment reagent in the first incubation period. This releases any vitamin D from the endogenous vitamin D binding protein present in the patient's sample. In the next incubation, vitamin D binding protein labeled with ruthenium is added and a complex is formed between the vitamin D (25-OH) and the ruthenylated vitamin D binding protein. In the 30 and final incubation, streptavidin-coated microparticles are added along with vitamin D (25-OH) labeled with biotin. Any unbound ruthenium labeled vitamin D binding proteins become occupied with biotin-labeled vitamin D (25-OH). The complex consisting of the ruthenylated vitamin D binding protein and the biotinylated vitamin D (25-OH) becomes bound to the solid phase via interaction of the biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the electrochemiluminescence emission is detected. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration provided with the reagent bar code.
(2) The Elecsys Vitamin D CalSet is a lyophilized product based on human serum. It has been standardized against LC-MS/MS, which has in turn been standardized to the NIST standard. .
(3) The Elecsys PreciControl Varia 3 is a multi-composite lyophilized 3 level control set which has been previously cleared for 7 components . The Elecsys PreciControl Varia 3 has been cleared under K111506 for the following analytes: Vitamin B12, Ferritin, Folate III, betaCrossLaps/Serum (-CTx), Osteocalcin, Parathyroid Hormone, Parathyroid Hormone Short Turnaround Time (PTH-STAT).
(4) The Elecsys Vitamin D CalCheck 5 contains 5 lyophilized levels based on human serum.
The provided document describes the Elecsys Vitamin D Assay and its associated calibrators and controls. The acceptance criteria and the study that proves the device meets the acceptance criteria are mainly focused on the Elecsys Vitamin D Assay itself, with comparisons to a predicate device and LC-MS/MS.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a separate section with numerical targets. Instead, it presents "Labeled Performance Characteristics" which serve as the performance specifications the device aims to meet. The comparison to the predicate device and LC-MS/MS provides evidence of its performance.
| Performance Characteristic | Acceptance Criteria (Implied / Predicate) | Elecsys Vitamin D Assay Performance |
|---|---|---|
| Measuring Range | Predicate: 13-96 ng/mL | 5-60 ng/mL (This is a key difference, indicating a wider lower range for the Elecsys) |
| Precision (Within-run) | Predicate: 3.1% CV @ 23.0 ng/mL, 2.6% CV @ 42.5 ng/mL, 1.4% CV @ 75.4 ng/mL | Elecsys 2010/cobas e 411 (n=84, human sera):7.2% CV @ 6.2 ng/mL5.1% CV @ 11.2 ng/mL2.9% CV @ 23.2 ng/mL2.4% CV @ 45.3 ng/mL1.6% CV @ 52.6 ng/mL |
| Precision (Total) | Predicate: 4.0% CV @ 23.0 ng/mL, 3.2% CV @ 42.5 ng/mL, 2.7% CV @ 75.4 ng/mL | Elecsys 2010/cobas e 411:10.3% CV @ 6.2 ng/mL7.6% CV @ 11.2 ng/mL5.3% CV @ 23.2 ng/mL3.4% CV @ 45.3 ng/mL2.9% CV @ 52.6 ng/mL |
| Analytical Sensitivity | Predicate: Limit of Blank: 1.9 ng/mL, Limit of Detection: 3.1 ng/mL, Limit of Quantitation (LoQ): 8.0 ng/mL | Limit of Blank (LoB): 2.00 ng/mLLimit of Detection (LoD): 3.00 ng/mLLimit of Quantitation (LoQ): 5.00 ng/mL (Lower LoQ than predicate) |
| Analytical Specificity (Cross Reactivity) | Predicate cross-reactivity percentages for various Vitamin D metabolites (e.g., 25-hydroxyvitamin D3: 105%, 25-hydroxyvitamin D2: 82%, 24,25-hydroxyvitamin D3: 112%, 1,25-hydroxyvitamin D3: 12.6%) | Elecsys cross-reactivity percentages:25-hydroxyvitamin D3: 100%25-hydroxyvitamin D2: 92%24,25-hydroxyvitamin D3: 149%1,25-hydroxyvitamin D3: not detected1,25-hydroxyvitamin D2: not detectedVitamin D3: not detectedVitamin D2: not detectedC3-epimer of 25-hydroxyvitamin D3: 91% |
| Method Comparison (vs. LC-MS/MS) | N/A (Comparison with a Gold Standard for traceability) | Deming (n=290): Slope: 1.03, Intercept: -3.07, r: 0.85 |
| Method Comparison (vs. Predicate) | N/A (Comparison with the predicate device to demonstrate substantial equivalence) | Deming (n=165): Slope: 0.99, Intercept: 1.20, r: 0.91 |
| Hook Effect | Predicate: Unknown | There is no high-dose hook effect since the Elecsys Vitamin D assay is a competitive assay. |
| Interference | Predicate: Unaffected by Hemoglobin <200 mg/dL, Bilirubin up < 20 mg/dL, Triglycerides < 5000 mg/dL, HAMA<1000 ng/mL, Rheumatoid Factor <400 IU/mL. (Biotin not tested) | Unaffected by:• Hemoglobin < 2 g/L (<2000 mg/dL)• Bilirubin up ≤ 66 mg/dL• Lipemia < 400 mg/dL• Biotin < 70 ng/mL• HAMA and Rheumatoid factors were not assessed because the assay does not utilize antibodies (This is a difference in assay design) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Method Comparison (Test Set Data):
- Versus LC-MS/MS: n=290 (for Deming regression analysis)
- Versus Predicate (Abbott Architect 25-OH Vitamin D assay): n=165 (for Deming regression analysis)
- Precision Studies: n=84 (human sera for Within-run and Total precision)
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a clinical assay submission, the samples would typically be human biological samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- The document does not mention the use of experts to establish ground truth for the test set in the context of reader studies for image analysis or similar diagnostic interpretations. Instead, for the analytical performance of the vitamin D assay, the "gold standard" or reference method (LC-MS/MS) serves as the ground truth for method comparison. Experts would be involved in performing and interpreting LC-MS/MS results, but their specific number and qualifications are not detailed here.
4. Adjudication Method (for the test set)
- Not applicable. This is an in vitro diagnostic (IVD) assay and not an imaging device that requires human expert adjudication for interpretation. The performance is assessed against reference methods (LC-MS/MS) and comparisons to the predicate device.
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 device is an automated in vitro diagnostic assay (Vitamin D assay) and does not involve human readers for interpretation, nor does it incorporate AI for diagnostic assistance. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the performance characteristics provided (Measuring Range, Precision, Sensitivity, Specificity, Method Comparison, Hook Effect, Limitations) represent the standalone performance of the Elecsys Vitamin D Assay as an algorithm/device without human-in-the-loop diagnostic interpretation. The assay is intended for use on Elecsys and cobas e immunoassay analyzers, which are automated systems.
7. The Type of Ground Truth Used
- Method Comparison: The primary ground truth for the analytical accuracy of the Elecsys Vitamin D Assay is LC-MS/MS (Liquid Chromatography-Mass Spectrometry), which is stated to be traceable to the NIST (National Institute of Standards and Technology) standard. This is considered a highly accurate and standardized reference method for measuring vitamin D.
- Precision, Sensitivity, Specificity, etc.: For these performance characteristics, the "ground truth" is established through carefully controlled experimental protocols using known concentrations of analytes, spiked samples, and characterized human sera/plasma.
8. The Sample Size for the Training Set
- The document does not explicitly state the sample size used for a "training set." For an IVD assay like this, development typically involves internal studies to optimize reagents and calibration, but the term "training set" is more commonly associated with machine learning models. The presented data represents validation studies, which are analogous to a test set in machine learning. However, the document does mention different sample sizes for different studies (e.g., n=290 for LC-MS/MS comparison, n=165 for predicate comparison, n=84 for precision).
9. How the Ground Truth for the Training Set Was Established
- As mentioned above, the concept of a "training set" with ground truth establishment in the machine learning sense is not directly applicable here. The development of reagents and assays involves iterative optimization and validation against known standards and reference methods. The assay is standardized against LC-MS/MS, which is standardized to the NIST standard, implying that the fundamental accuracy is rooted in these established reference measurement procedures and materials.
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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 Name, Address, Contact | Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250(317) 521-2458Contact Person: Michael Leuther, PhD, MBADate Prepared: July 18, 2012 |
| Device Name | Proprietary name: (1) Elecsys Vitamin D Assay(2) Elecsys Vitamin D CalSet(3) Elecsys PreciControl Varia 3(4) Elecsys Vitamin D CalCheck 5Common name: (1) Vitamin D Assay(2) Vitamin D Calibrator(3) Vitamin D Control(4) Vitamin D CalCheck 5Classification name: (1) System, Test, Vitamin D(2) Calibrator, Secondary(3) Multi-analyte controls, all kinds (Assayed and Unassayed)(4) Single (specified) analyte controls (Assayed and Unassayed) |
.
· . :
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510(k) Summary, Continued
Device Description
(1) The Elecsys Vitamin D Assay is a competitive protein binding assay which uses Vitamin D Binding Protein instead of monoclonal antibodies for detection of 25-Hydroxyvitamin D. The total duration of the assay is 27 minutes. The sample is treated with pretreatment reagent in the first incubation period. This releases any vitamin D from the endogenous vitamin D binding protein present in the patient's sample. In the next incubation, vitamin D binding protein labeled with ruthenium is added and a complex is formed between the vitamin D (25-OH) and the ruthenylated vitamin D binding protein. In the 30 and final incubation, streptavidin-coated microparticles are added along with vitamin D (25-OH) labeled with biotin. Any unbound ruthenium labeled vitamin D binding proteins become occupied with biotin-labeled vitamin D (25-OH). The complex consisting of the ruthenylated vitamin D binding protein and the biotinylated vitamin D (25-OH) becomes bound to the solid phase via interaction of the biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the electrochemiluminescence emission is detected. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration provided with the reagent bar code.
(2) The Elecsys Vitamin D CalSet is a lyophilized product based on human serum. It has been standardized against LC-MS/MS, which has in turn been standardized to the NIST standard. .
(3) The Elecsys PreciControl Varia 3 is a multi-composite lyophilized 3 level control set which has been previously cleared for 7 components . The Elecsys PreciControl Varia 3 has been cleared under K111506 for the following analytes:
| Assay Name | FDA Clearance Number forReagents |
|---|---|
| Vitamin B12 | K060755 |
| Ferritin | K971833 |
| Folate III | K082340 |
| βCrossLaps/Serum (-CTx) | K993706 |
| Osteocalcin | K051297 |
| Parathyroid Hormone | K070709 |
| Parathyroid Hormone ShortTurnaround Time (PTH-STAT) | K070709 |
(4) The Elecsys Vitamin D CalCheck 5 contains 5 lyophilized levels based on human serum.
Note: The reagent, calibrator, and the quality control materials are all packaged separately.
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510(k) Summary, Continued
| IntendedUse/Indicationsfor Use | • Elecsys Vitamin D Reagent:The Elecsys Vitamin D assay is intended for the quantitativedetermination of total 25-hydroxyvitamin D in human serum andplasma. The assay is to be used as an aid in the assessment ofvitamin D sufficiency in adults.The electrochemiluminescence binding assay is intended for use onElecsys and cobas e immunoassay analyzers. |
|---|---|
| • Elecsys Vitamin D CalSet: Elecsys Vitamin D CalSet is used forcalibrating the quantitative Elecsys Vitamin D assay on the Elecsysand cobas e immunoassay analyzers. | |
| • Elecsys PreciControl Varia 3: Elecsys PreciControl Varia 3 isused for quality control of the specified Elecsys immunoassays onthe Elecsys and cobas e immunoassay analyzers. | |
| • Elecsys Vitamin D CalCheck 5: The Elecsys Vitamin D CalCheck5 is an assayed control for use in calibration verification and for usein the verification of the assay range established by the ElecsysVitamin D reagent on the indicated Elecsys and cobas eimmunoassay analyzers. |
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510(k) Summary, Continued
Substantial The Elecsys Vitamin D Test System is substantially equivalent to other -Equivalence devices legally marketed in the United States. (1) Elecsys Vitamin D Assay is equivalent to the Abbott Architect 25-OH Vitamin D assay (K110619). (2) Elecsys Vitamin D CalSet is equivalent to the standards contained in the Elecsys hGH CalSet (K103221) (Human Growth Hormone). (3) Elecsys PreciControl Varia 3 is equivalent to the controls contained in the PreciControl Multimarker (K102157). (4) The Elecsys Vitamin D CalCheck 5 is equivalent to the Elecsys T4 CalCheck 5 (K112528).
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Premarket Notification, 510(k) for Elecsys Vitamin D Test System ので、その他の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の
| SubstantialEquivalence -Comparison | The following table compares the Elecsys Vitamin D Test System with thepredicate device. The next three tables compare the Elecsys Vitamin DCalSet, CalCheck 5, and PreciControl Varia 3 to their predicates. |
|---|---|
| -------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Comparison of Assays, Similarities and Differences Premarket Notification, 510(k) for Elecsys Vitamin D Test System
| Assay Comparison | ||
|---|---|---|
| Feature | Elecsys Vitamin D Assay | Predicate Device: Abbott Architect25-OH Vitamin D(K110619) |
| General Assay Features | ||
| IntendedUse/Indicationsfor Use | The Vitamin D assay is intended forthe quantitative determination of total25-hydroxyvitamin D in human serumand plasma. This assay is to be usedas an aid in the assessment of vitaminD sufficiency in adults.The electrochemiluminescencebinding assay is intended for use onElecsys and cobas e immunoassayanalyzers. | The Abbott Architect 25-OH VitaminD assay is a chemiluminescentmicroparticle immunoassay (CMIA)for the quantitative determination of25-hydroxyvitamin D (25-OH vitaminD) in human serum or plasma. TheArchitect 25-OH Vitamin D assay is tobe used as an aid in the assessment ofvitamin D sufficiency. |
| AssayProtocol | Quantitative protein binding assay | Quantitative chemiluminescenceimmunoassay |
| DetectionProtocol | Electrochemiluminescence | Chemiluminescence |
| Applications | 27 minute application | 36 minutes (time to first result) |
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Premarket Notification, 510(k) for Elecsys Vitamin D Test System, Continued .
| Assay Comparison | ||||
|---|---|---|---|---|
| Feature | Elecsys Vitamin D Assay | Predicate Device: AbbottArchitect 25-OH Vitamin D(K110619) | ||
| General Assay Features | ||||
| InstrumentPlatform | Elecsys 2010 and cobas e 411 | Abbott Architect 25-OH Vitamin D | ||
| SampleVolume | 15 uL | 60 uL for first run, 10 uL foradditional runs | ||
| SampleType | Human serum and plasma treated withK2-EDTA, K3-EDTA or lithiumheparin. | Human serum, plasma treated withlithium heparin, sodium heparin,potassium EDTA, or sodium citrate. | ||
| Reagents | The Elecsys Vitamin D assay is acompetitive binding assay whichincludes vitamin D (25-OH) labeledwith biotin, and a ruthenium labeledvitamin D binding protein, andstreptavidin coated microparticles. | The Abbott Architect 25-OH VitaminD assay is a competitive one-stepdelayed immunometric assay whichincludes anti-vitamin D coatedmicroparticles, an assay diluent, andbiotinylated vitamin D anti-biotinacridinium labeled conjugate. | ||
| Calibrator | Elecsys Vitamin D CalSet, 2 levels | Architect 25-OH Vitamin DCalibrators, 6 levels |
Comparison of Assays—Similarities and Differences, continued
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Premarket Notification, 510(k) for Elecsys Vitamin D Test System, Continued ·
Comparison of Assays-Similarities and Differences, continued
| Assay Comparison | ||
|---|---|---|
| Feature | Elecsys Vitamin D Assay | Predicate Device: AbbottArchitect 25-OH Vitamin D(K110619) |
| CalibrationInterval | 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:After 1 month (28 days) whenusing the same reagent lot. After 7 days (when using thesame reagent kit on theanalyzer). As required: e.g. qualitycontrol findings outside thespecified limits | Calibration must be performed:After 7 days When a control value is out ofrange |
| Controls | Elecsys PreciControl Varia 3 | Architect 25-OH Vitamin D Controls |
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Premarket Notification, 510(k) for Elecsys Vitamin D Test System, Continued
Comparison of Assays-Similarities and Differences, continued
| Assay Comparison | ||
|---|---|---|
| Feature | Elecsys Vitamin D Assay | Predicate Device: AbbottArchitect 25-OH Vitamin D(K110619) |
| General assay features | ||
| Traceability /Standardization | The Elecsys Vitamin D Assay hasbeen standardized against LC-MS/MSwhich in turn has been standardized tothe NIST standard. | Architect 25-OH Vitamin D istraceable to a manufacturer'sinternal standard (PrimaryCalibrator), which is anchoredagainst Absorbance at 264 nm. |
| ReagentStability | Unopened at 2-8 oC-up to statedexpiration dateAfter opening at 2-8 oC—56 daysOn the Elecsys 2010 and cobas e411—21 days | Unopened at 2-8 oC-up to statedexpiration date.After opening: on-board theanalyzer for 14 days |
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System, Continued Comparison of Assays-Similarities and Differences, continued
| Assay Comparison | ||
|---|---|---|
| Feature | Elecsys Vitamin D Assay | Predicate Device: AbbottArchitect 25-OH Vitamin D(K110619) |
| Labeled Performance Characteristics | ||
| MeasuringRange | 5-60 ng/mL | 13-96 ng/mL |
| Precision | Elecsys 2010/ cobas e 411:Within-run (will be labeled Repeatability)n=84, human sera7.2% CV @ 6.2 ng/mL5.1% CV @ 11.2 ng/mL2.9% CV @ 23.2 ng/mL2.4% CV @ 45.3ng/mL1.6% CV @ 52.6 ng/mLTotal (will be labeled Intermediate)10.3% CV @ 6.2 ng/mL7.6% CV @ 11.2 ng/mL5.3% CV @ 23.2 ng/mL3.4% CV @ 45.3ng/mL2.9% CV @ 52.6 ng/mL | Abbott Architect 25-OH Vitamin DWithin-runn=80, human sera3.1% CV @ 23.0 ng/mL2.6% CV @ 42.5 ng/mL1.4% CV @ 75.4 ng/mLTotal4.0% CV @ 23.0 ng/mL3.2% CV @ 42.5 ng/mL2.7% CV @ 75.4 ng/mL |
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:
Premarket Notification, 510(k) for Elecsys Vitamin D Test System, Continued
Comparison of Assays-Similarities and Differences, continued
| Assay Comparison | ||||
|---|---|---|---|---|
| Feature | Elecsys Vitamin D Assay | Predicate Device: AbbottArchitect 25-OH Vitamin D(K110619) | ||
| Labeled Performance Characteristics | ||||
| AnalyticalSensitivity | Limit of Blank (LoB) 2.00 ng/mLLimit of Detection (LoD) 3.00 ng/mLLimit of Quantitation (LoQ) 5.00ng/mL | Limit of Blank: 1.9 ng/mLLimit of Detection: 3.1 ng/mLLLimit of Quantitation (LoQ) 8.0ng/mL | ||
| AnalyticalSpecificity | Cross Reactant25-hydroxyvitamin D325-hydroxyvitamin D224,25-hydroxyvitamin D31,25-hydroxyvitamin D31,25-hydroxyvitamin D2Vitamin D3Vitamin D2C3-epimer of 25-hydroxyvitamin D3 | Cross ReactantCrossReactivity(%)10092149not detectednot detectednot detectednot detected91 | Cross Reactant25-hydroxyvitamin D325-hydroxyvitamin D224,25-hydroxyvitamin D31,25-hydroxyvitamin D31,25-hydroxyvitamin D2Vitamin D3Vitamin D2C3-epimer of 25-hydroxyvitamin D3 | CrossReactivity(%)1058211212.6Not tested0.30.12.7 |
| Hook Effect | There is no high-dose hook effectsince the Elecsys Vitamin D assay is acompetitive assay | Unknown | ||
| Limitations | The assay is unaffected by:• Hemoglobin < 2 g/L• Bilirubin up ≤ 66 mg/dL• Lipemia < 400 mg/dL• Biotin < 70 ng/mL• HAMA and Rheumatoid factors werenot assessed because the assay does notutilize antibodies | The assay is unaffected by:• Hemoglobin <200 mg/dL• Bilirubin up < 20 mg/dL• Triglycerides < 5000 mg/dL• Biotin not tested• HAMA<1000 ng/mL• Rheumatoid Factor <400 IU/mL |
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System, Continued
Comparison of Assays-Similarities and Differences, continued
| Assay Comparison | ||||
|---|---|---|---|---|
| Feature | Elecsys Vitamin D Assay | Predicate Device: AbbottArchitect 25-OH Vitamin D(K110619) | ||
| Labeled Performance Characteristics | ||||
| Method Comparison(LC-MS/MS vs. Elecsys) | Deming(n=290) | Slope | Intercept | r |
| 1.03 | -3.07 | 0.85 | ||
| Method ComparisonAbbott vs. Elecsys) | Deming(n=165) | Slope | Intercept | r |
| 0.99 | 1.20 | 0.91 |
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System, Continued Comparison of CalSet Materials
| Characteristic | CalSet for Elecsys Vitamin D Assay | Predicate Device: Elecsys hGHCalSet (K103221) |
|---|---|---|
| Intended Use | Elecsys Vitamin D CalSet is used forcalibrating the quantitative ElescysVitamin D assay on the Elecsys andcobas e immunoassay analyzers. | Elecsys hGH CalSet is used forcalibrating the quantitative ElecsyshGH assay on the Elecsys andcobas e immunoassay analyzers. |
| Levels | Two | Same |
| Matrix | Human serum | Same |
| Format | Lyophilized | Same |
| Stability | Unopened:• Store at 2 - 8 °C up to the statedexpiration date.After reconstitution:• At 2 - 8°C: 120 hours• At -20°C: 90 days (freeze onlyonce).• On Elecsys 2010/cobas e 411 at 20- 25°C: Up to 5 hours. | Unopened:• Store at 2 - 8 °C up to the statedexpiration date.After reconstitution:• At 2 - 8 °C: 7 days• At -20°C: 28 days (freeze onlyonce).• On Elecsys 2010/cobas e 411 at20 - 25°C: Up to 5 hours.On MODULAR ANALYTICSE170/cobas e 601: Use only once. |
| Handling | Dissolve the contents of one bottlecarefully by adding exactly 1.0 mL ofdistilled water and allow to standclosed for 15 minutes to reconstitute.Mix carefully, avoiding the formationof foam. Transfer the reconstitutedcalibrator into the empty labeled snap-cap bottles supplied. | Dissolve carefully the contents ofone bottle by adding exactly 1.0 mLof distilled or deionized water andallow to stand closed for 15 minutesto reconstitute. Mix carefully,avoiding the formation of foam.Transfer the reconstituted calibratorinto the empty labeled snap-capbottle supplied. |
| Characteristic | Elecsys PreciControl Varia 3 | Predicate Device:Elecsys PreciControlMultimarker (K102157) |
| Intended Use | Elecsys PreciControl Varia 3 is used forquality control of Elecsys immunoassayson the Elecsys and cobas e immunoassayanalyzers. | Elecsys PreciControl Multimarker isused for quality control of specifiedElecsys immunoassays on the Elecsysand cobas e immunoassay analyzers. |
| Levels | Three | Two |
| Format | Lyophilized | Same |
| Matrix | Human serum | Equine serum |
| AnalyteConcentration | 25-hydroxyvitamin D (synthetic) inhuman serum at target values ofapproximately:V3 0: 12.8 ng/mLV3 1: 17 ng/mLV3 2: 32 ng/mL | C-Peptide (synthetic): Approximately2 and 10 ng/mL.Insulin (human recombinant fromyeast): Approximately 25 and 80μU/mL.ACTH (synthetic): Approximately 50and 1,000 pg/mL.hGH (human recombinant from E.coli): Approximately 1 and 10 ng/mL. |
| Stability | Unopened:• Store at 2-8°C up to the statedexpiration dateReconstituted:• 2 - 8°C: 72 hours• -20°C: 31 days(freeze only once)• On the analyzers at 20-25°C: up to 5hours | Unopened:• Store at 2-8°C up to the statedexpiration dateReconstituted:• 2 - 8°C: 72 hours• -20°C: 31 days (freeze only once)• On the analyzers at 20-25°C: up to5 hours |
| Handling | Carefully dissolve the contents of onebottle by adding exactly 3.0 mL ofdistilled or deionized water and allow tostand closed for 30 minutes toreconstitute. Mix carefully, avoiding theformation of foam. Transfer thereconstituted control into the empty,labeled snap-cap bottles supplied orfreeze aliquots in additional snap-capbottles (ControlSet Vials). Attach thesupplied labels to these bottles. Performonly one control procedure per aliquot. | Dissolve carefully the contents of onebottle by adding exactly 2.0 mL ofdistilled or deionized water and allowto stand closed for 30 minutes toreconstitute. Mix carefully, avoidingthe formation of foam. Transfer thereconstituted control into empty,labeled snap-cap bottles supplied(ControlSet Vials) and freeze aliquotsimmediately in additional ControlSetVials. Attach the supplied labels tothese additional bottles. Perform onlyone control procedure per aliquot. |
| Characteristic | Elecsys Vitamin D CalCheck 5 | Predicate Device:Elecsys T4 CalCheck 5 (K112528) |
| Intended Use | The Elecsys Vitamin D CalCheck 5 is anassayed control for use in calibrationverification and for use in the verificationof the assay range established by theElecsys Vitamin D reagent on theindicated Elecsys and cobas eimmunoassay analyzers. | The Elecsys T4 CalCheck 5 is anassayed control for use in calibrationverification and for use in theverification of the assay rangeestablished by the Elecsys T4 reagenton the indicated Elecsys and cobas eimmunoassay analyzers. |
| Analyte | (25-OH) Vitamin D | Thyroxine (T4) |
| Levels | Five | Same |
| Matrix | Human serum | Check 1: BSA/Buffer matrixCheck 2-5: human serum |
| Format | Lyophilized | Same |
| Handling | Reconstitute Check 1, Check 2, Check 3,Check 4 and Check 5 with exactly 1.0 mLdistilled or deionized water. Allow tostand closed for 15 minutes, then mixgently by inversion to ensurehomogeneity. | Same |
| Stability | Unopened:Store at 2-8 °C until expiration date Reconstituted: 20-25 °C: 5 hours | Same |
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System, Continued Comparison of PreciControl Materials
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System, Continued Comparison of CalCheck 5 Materials
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/14/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
JUL 2 4 2012
Roche Diagnostics c/o Michael Leuther, PhD, MBA Roche Professional Diagnostics 9115 Hague Road Indianapolis, IN 46250
RE: K113546
Trade Name: Elecsys Vitamin D Assay Elecsys Vitamin D CalSet Elecsys PreciControl Varia 3 Elecsys Vitamin D Calchek 5 Regulation Number: 21 CFR §862.1825 Regulation Name: Vitamin D test system Regulatory Class: Class II Product Codes: MRG, JIT,JJY,JJX Dated: July 5, 2012 Received: July 6, 2012
Dear Dr. Leuther:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
Q. H. Liao, Ph.D.
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Confidential
Indications for Use Form
510(k) Number (if known):
Device Name: Elecsys Vitamin D Assay
Indications for Use:
The Elecsys Vitamin D assay is intended for the quantitative determination of total 25-hydroxy vitamin D in human serum and plasma. The Elecsys Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency in adults.
The electrochemiluminescence binding assay is intended for use on 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 Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113546
Page 1 of 4
Page 33 of 264
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Elecsys Vitamin D 510(K) Submission
Confidential
Indications for Use Form
510(k) Number (if known): _
Elecsys Vitamin D CalSet Device Name:
Indications for Use: Elecsys Vitamin D CalSet is used for calibrating the quantitative Elecsys Includions 10. 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 Diagnostic Devices (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113546
Page 2 of 4 Rage 34 of 264
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Elecsys Vitamin D 510(K) Submission
Confidential
Indications for Use Form
510(k) Number (if known):
Elecsys PreciControl Varia 3 Device Name:
Indications for Use: Elecsys PreciControl Varia 3 is used for quality control of specified Elecsys immunoassays on 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 Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) i<113546
Page 3 of 4
Page 25 of 264
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Elecsys Vitamin D 510(K) Submission
Confidential
Page 1 of __
Indications for Use Form
510(k) Number (if known):
Elecsys Vitamin D CalCheck 5 Device Name: ____
Indications for Use: The Elecsys Vitamin D CalCheck 5 is an assayed control for use in calibration Incifications for USe. The Enceys ration of the assay range established by the Elecsys Vitamin D reagent on the indicated 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 Diagnostic Devices (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113546
Page 4 of 4
Page 36 of 264
§ 862.1825 Vitamin D test system.
(a)
Identification. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.(b)
Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:(1) Labeling in conformance with 21 CFR 809.10 and
(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.