(227 days)
The ADVIA Centaur Vitamin D Total (VitD) assay is for the in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium heparin, sodium heparin) using the ADVIA Centaur XP system. The ADVIA Centaur VitD assay is intended as an aid in the determination of vitamin D sufficiency.
The ADVIA Centaur Vitamin D Total (VitD) Calibrators is for in vitro diagnostic use in calibrating ADVIA Centaur® systems Vitamin D Total (VitD) assay.
The ADVIA Centaur Vitamin D Total (VitD) QC is for in vitro diagnostic use to monitor the precision and accuracy of the ADVIA Centaur® VitD assay on the ADVIA Centaur systems.
The ADVIA Centaur® Vitamin D Total (VitD) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur VitD assay.
The ADVIA Centaur Vitamin D Total assay is a one-pass 18 minute competitive immunoassay that uses an anti-fluorescein labeled (FITC) monoclonal antibody covalently bound to paramagnetic particles (PMP), one monoclonal antibody labeled with acridium ester (AE), and a Vitamin D analog labeled with fluorescein. An inverse relationship exists between the amount of Vitamin D present in the patient sample and the amount of relative light units (RLUs) detected by the system.
Here's a summary of the acceptance criteria and study information for the ADVIA Centaur Vitamin D Total Assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device and the successful results for various performance characteristics. The document states that "All of the evaluation studies gave acceptable results compared to the predicate device." Therefore, the reported performance is within the acceptable range as defined by the predicate device and established analytical standards.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (ADVIA Centaur Vitamin D Total Assay) |
|---|---|---|
| Analytical Sensitivity | Acceptable for Vitamin D test systems (vs. K021163) | LoB = 1.60 ng/mL, LoD = 3.2 ng/mL, LoQ = 4.2 ng/mL |
| Imprecision (Total CV) | Comparable to predicate for similar levels | Level 11.7 ng/mL: 11.1%Level 18.0 ng/mL: 9.6%Level 32.4 ng/mL: 9.8%Level 49.9 ng/mL: 8.2%Level 55.8 ng/mL: 7.8%Level 132.1 ng/mL: 4.8% |
| Specificity (Cross-Reactivity) | Low cross-reactivity for related compounds | 1,25 (OH)2 Vitamin D2: 4.0%1,25 (OH)2 Vitamin D3: 1.0%25 OH Vitamin D2: 104.5%25 OH Vitamin D3: 100.7%Paricalcitol: 0.1%3-epi-25-OH Vitamin D3: 1.1%Vitamin D2: 0.5%Vitamin D3: 0.3% |
| Interfering Substances | ≤ 10% change in results for specified concentrations | Hemoglobin: 155 mg/dLTriglycerides: 540 mg/dLConjugated Bilirubin: 40 mg/dLUnconjugated Bilirubin: 40 mg/dLCholesterol: 350 mg/dLUric Acid: 20 mg/dLHuman Immunoglobulin: 12 g/dL |
| Method Comparison (Correlation with Predicate) | Strong correlation (vs. K021163) | n = 195, r = 0.960, Slope = 1.0, Y-intercept = +2.22 |
| Serum/Plasma Equivalency | No significant differences between tube types | R values: Serum vs. SST: 0.994, Serum vs. EDTA: 0.993, Serum vs. Lithium Heparin: 0.992, Serum vs. Sodium Heparin: 0.992 |
2. Sample Sizes Used for the Test Set and Data Provenance
- Method Comparison: n = 195 samples. The provenance of this data (country of origin, retrospective/prospective) is not explicitly stated.
- Imprecision: n = 160 (Total CV). It's typically from replicate measurements on control samples over multiple runs.
- Specificity: Not a sample size in the traditional sense, but tested with specific concentrations of various compounds.
- Interfering Substances: Tested as described in CLSI Document EP7-A2. Specific sample sizes for each interfering substance are not provided, but it would involve spiking known concentrations into samples.
- Serum/Plasma Equivalency: n = 231 matched specimens drawn in different tube types. The provenance of this data (country of origin, retrospective/prospective) is not explicitly stated.
The document does not specify the country of origin of the data or whether the studies were retrospective or prospective for the various performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to an in vitro diagnostic (IVD) assay like the ADVIA Centaur Vitamin D Total Assay. The "ground truth" for these assays is usually established through:
- Reference Methods: For method comparison, the predicate device (IDS 25-OH Vitamin D EIA assay, K021163) or a recognized reference method like LC-MS/MS (mentioned for traceability of the ADVIA Centaur assay) serves as the comparator.
- Known Concentrations: For analytical sensitivity, imprecision, specificity, and interfering substances, the "ground truth" is based on precisely prepared samples with known concentrations of the analyte or interfering substances.
Therefore, no panel of human experts was used to establish ground truth for this device.
4. Adjudication Method for the Test Set
Not applicable. As this is an IVD assay measuring biochemical analytes, there is no adjudication process involving human review for the "test set" in the way one might see in imaging studies. The results are quantitative and compared against established analytical methods or known values.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is not relevant for this type of IVD device, which is an automated assay for blood analysis. MRMC studies are typically performed for diagnostic imaging devices where human interpretation is a critical component.
6. Standalone Performance Study
Yes, the studies described (Analytical Sensitivity, Imprecision, Specificity, Interfering Substances, Serum/Plasma Equivalency) represent the standalone performance of the ADVIA Centaur Vitamin D Total Assay. The "Method Comparison" against the predicate device also serves to demonstrate that the algorithm (assay) performs comparably to an already established method without human interpretation required for its output.
7. Type of Ground Truth Used
The ground truth used for this device includes:
- Reference Assay/Predicate Device: For method comparison, the results generated by the IDS 25-OH Vitamin D EIA assay (K021163) served as the comparator.
- Traceability to LC-MS/MS: The ADVIA Centaur assay's traceability to LC-MS/MS (Liquid Chromatography-Mass Spectrometry) indicates that for its fundamental accuracy and standardization, it references a highly precise and accurate analytical method often considered a gold standard for vitamin D measurement.
- Known/Spiked Concentrations: For studies like analytical sensitivity, imprecision, specificity, and interfering substances, the ground truth is based on samples with precisely known concentrations of the analyte or potential interfering substances.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI, as this is a traditional immunoassay. For such assays, method development and optimization phases involve extensive testing to establish reagent formulations, reaction conditions, and calibration algorithms. The data used for this developmental work is not typically reported as a "training set" in the same way it would be for an AI-based device.
9. How the Ground Truth for the Training Set Was Established
As this is a traditional immunoassay and not an AI/ML device, the concept of a "training set" with established ground truth as understood in AI development is not directly applicable. Instead, the assay's performance characteristics (calibration, linearity, imprecision, accuracy) would have been optimized and validated using a combination of:
- Reference standards: Materials with assigned values, often traceable to higher-order reference methods like LC-MS/MS.
- Clinical samples: Patient samples covering a range of analyte concentrations.
- Spiked samples: Samples with known quantities of analyte added.
- Internal quality control materials: Samples with established target values.
The "ground truth" during development would be established through careful analytical measurements using these standards and methods to ensure the assay accurately quantifies vitamin D.
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OCT 1 4 2011
510(k) Summary
| Submitter information | |
|---|---|
| Contact person: | Neil ParkerSenior Regulatory Affairs Specialist |
| Address: | Siemens Healthcare Diagnostics511 Benedict AvenueTarrytown, NY 10591 |
| Phone: | 914-524-2477914-524-2500 (fax) |
Date summary prepared: February 28, 2011
Device Trade or Proprietary Names:
ADVIA Centaur Vitamin D Total Assay
ADVIA Centaur Vitamin D Total calibrators
ADVIA Centaur Vitamin D Total QC
ADVIA Centaur Vitamin D Total Master Curve Material
Device Common/Usual Name or Classification Name:
Vitamin D Test System Calibrator Quality Control Material (Assayed and Unassayed)
Classification Number / Class:
21 CFR 862.1825 - Vitamin D Test System - Class II 21 CFR 862.1150 - Calibrator - Class II 21 CFR 862.1660 - Quality Control Material (Assayed and Unassayed) - Class I
Siemens Healthcare Diagnostics ADVIA Centaur Vitamin D Total assay 510(k) Summary
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Product code:
MRG - Vitamin D Test system JIT - Calibrator, Secondary JJX - single (specified) Analyte Controls (Assayed and Unassayed)
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: __
Assay Predicate Device (including calibrators and controls):
| Predicate Device | |
|---|---|
| Device Name | IDS 25-Hydroxy Vitamin D EIA |
| Common name | Vitamin D Test System |
| 510(k) Number | K021163 |
| Manufacturer | Immunodiagnostic Systems Ltd (IDS Ltd) |
Master Curve Material Predicate Device
| Predicate Device | ||
|---|---|---|
| Device Name | The VALIDATE Thyroid Calibration Verification TestSet | |
| Common name | single (specified) Analyte Controls (Assayedand Unassayed) | |
| 510(k) Number | K062501 | |
| Manufacturer | Maine Standards Company |
Device Description:
The ADVIA Centaur Vitamin D Total assay is a one-pass 18 minute competitive immunoassay that uses an anti-fluorescein labeled (FITC) monoclonal antibody covalently bound to paramagnetic particles (PMP), one monoclonal antibody labeled with acridium ester (AE), and a Vitamin D analog labeled with fluorescein. An inverse relationship exists between the amount of Vitamin D present in the patient sample and the amount of relative light units (RLUs) detected by the system.
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Statements of Intended Use:
The ADVIA Centaur Vitamin D Total (VitD) assay is for the in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium heparin, sodium heparin) using the ADVIA Centaur XP system. The ADVIA Centaur VitD assay is intended as an aid in the determination of vitamin D sufficiency.
The ADVIA Centaur Vitamin D Total (VitD) Calibrators is for in vitro diagnostic use in calibrating ADVIA Centaur® systems Vitamin D Total (VitD) assay.
The ADVIA Centaur Vitamin D Total (VitD) QC is for in vitro diagnostic use to monitor the precision and accuracy of the ADVIA Centaur® VitD assay on the ADVIA Centaur systems.
The ADVIA Centaur® Vitamin D Total (VitD) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur VitD assay.
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Comparisons to the Predicate Devices: Assay Similarities
| Items | ADVIA Centaur Vitamin D Totalassay | IDS 25-OH Vitamin D EIAassay (Predicate Device)K021163 |
|---|---|---|
| Similarity | ||
| Intended Use/Indication foruse | For the in vitro diagnostic use inthe quantitative determination oftotal 25 (OH) vitamin D in humanserum and plasma (EDTA,lithium-heparin, sodium-heparin)using the ADVIA Centaur XPsystem. The ADVIA Centaur VitDassay is intended as an aid in thedetermination of vitamin Dsufficiency. | SimilarThe IDS 25-OH Vitamin D EIAkit is an enzymeimmunoassayintended for the quantitativedetermination of 25-Hydroxyvitamin D and otherhydroxylated metabolites inhuman serum and plasma.Results are to be used inconjunction with other clinicaland laboratory data to assistthe clinician in the assessmentof vitamin D sufficiency inadult populations. |
| Sample Type | Serum and Plasma | same |
| Reagent storage temperature | 2-8°C | same |
| Interpretation of results | Standard curve | same |
| Expected Values | Deficiency < 10 ng/mLInsufficiency 10-29 ng/mLSufficiency 30-100 ng/mLToxicity > 100ng/mL | Same |
| Ranges established forapparently healthy adults not onsupplements:10.6 ng/mL to 43.4 ng/mLn = 542 | Ranges established adults19.1 ng/mL to 57.6 ng/mLn = 36 |
Assay Differences
| Items | ADVIA Centaur Vitamin D Totalassay | IDS 25-OH Vitamin D EIAassay (Predicate Device)K021163 |
|---|---|---|
| Differences | ||
| Platform | ADVIA Centaur XP | ELISA plate read on a platereader |
| Assay principle | Chemiluminescence | ELISA |
| Assay procedure | Automated | Manual |
| Approximate Assay time | 18 minute | 3.5 hours |
| Assay Range | 4.2 to 150 ng/mL | 5.9 to 120 ng/mL |
| Traceability | Traceable to LC-MS/MS | Standardized using UVquantification of 25-(OH)vitamin D |
Siemens Healthcare Diagnostics
ADVIA Centaur Vitamin D Total assay
510(k) Summary
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Calibrator Similarities
| Items | ADVIA Centaur Vitamin D Totalassay calibrators | IDS 25-OH Vitamin D EIAassay calibrators (PredicateDevice) K021163 |
|---|---|---|
| Similarity | ||
| Intended Use/Indication foruse | For in vitro diagnostic use incalibrating ADVIA Centaur®systems Vitamin D Total (VitD)assay. | Similar |
| Antigen used in calibrators | 25-(OH) vitamin D3 | same |
| Storage temperature | 2-8°C | same. |
Calibrator Differences
| Items | ADVIA Centaur Vitamin D Totalassay | IDS 25-OH Vitamin D EIAassay calibrators (PredicateDevice) K021163 |
|---|---|---|
| Differences | ||
| Number of calibrators | 2 | 6 |
| Matrix | Lyophilized human plasma | Lyophilized human serum |
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QC Similarities
| Items | ADVIA Centaur Vitamin D Totalassay controls | IDS 25-OH Vitamin D EIAassay controls (PredicateDevice) K021163 |
|---|---|---|
| Similarity | ||
| Intended Use/Indication foruse | For in vitro diagnostic use tomonitor the precision andaccuracy of the ADVIA Centaur®VitD assay on the ADVIACentaur systems. | Similar |
| Antigen used in controls | 25-(OH) vitamin D3 | same |
| Number of Levels | 2 | same |
| Storage temperature | 2-8°C | same |
QC Differences
| Items | ADVIA Centaur Vitamin D Totalassay controls | IDS 25-OH Vitamin D EIAassay controls (PredicateDevice) K021163 |
|---|---|---|
| Differences | ||
| Matrix | Lyophilized human plasma | Lyophilized human serum |
· :
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MCM Similarities
| Items | ADVIA Centaur Vitamin D Totalassay MCMs | Maine Standards CompanyVALIDATE Thyroid CalibrationVerification Test Set(K062501) |
|---|---|---|
| Similarity | ||
| Intended Use/Indication foruse | The ADVIA Centaur® Vitamin DTotal (VitD) Master CurveMaterial is for in vitro diagnosticuse in the verification ofcalibration and reportable rangeof the ADVIA Centaur VitDassay. | The VALIDATE ThyroidCalibration Verification TestSet solutions are for in vitrodiagnostic use in theuantitative determination oflinearity, calibration verificationand verification of reportablerange in automated, semi-automated and manualchemistry systems. |
| Number of Levels | 5 | Same |
MCM Differences
| Items | ADVIA Centaur Vitamin D Total assay MCMs | Maine Standards CompanyVALIDATE ThyroidCalibrationVerification Test Set(K062501) |
|---|---|---|
| Differences | ||
| Matrix | Human plasma | Human Serum |
| Form | Lyophilized | liquid |
| Analyte | 25 (OH) vitamin D | Triiodothyronine (T3),Thyroxine (T4), humanThyroid Stimulating Hormone(TSH), and Cortisol. |
Performance:
Substantial equivalence for the ADVIA Centaur Vitamin D Total assay was demonstrated by testing several method performance characteristics including Analytical Sensitivity, linearity, imprecision, method comparison, interfering substances, and specificity. The following tables summarize the analytical sensitivity, linearity, precision (total), interfering substances, specificity, serum / plasma equivalency and method comparison results.
All of the evaluation studies gave acceptable results compared to the predicate device. These studies support that the ADVIA Centaur Vitamin D Total assay (including the
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calibrators and controls) are substantially equivalent to the IDS 25-Hydroxy Vitamin D EIA that is currently marketed.
Analytical Sensitivity
LoB = 1.60 ng/mL LoD = 3.2 ng/mL LoQ = 4.2 ng/mL
Imprecision
| ADVIA Centaur Vitamin DTotal Assay | IDS 25-Hydroxy Vitamin D EIA | ||
|---|---|---|---|
| Level (ng/mL) | Total CV (%)n = 160 | Level (ng/mL) | Inter assay CV (%)n = 11 |
| 11.7 | 11.1 | ||
| 18.0 | 9.6 | ||
| 32.4 | 9.8 | 40.3 | 4.6 |
| 49.9 | 8.2 | ||
| 55.8 | 7.8 | 72.0 | 6.4 |
| 132.1 | 4.8 | 132.0 | 8.7 |
Specificity
The ADVIA Centaur VitD Total assay shows high specificity for 25(OH) vitamin D2 and 25(OH) vitamin D3. The following compounds were tested with total 25(OH) vitamin D concentrations of 35 and 115 ng/mL. Percent change is calculated as: Percent cross-reactivity = (corrected assay value / amount of compound spiked) x 100
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| Compound | Concentration (ng/mL) | Cross-Reactivity (%) |
|---|---|---|
| 1, 25 (OH)2 Vitamin D2 | 100 | 4.0 |
| 1, 25 (OH)2 Vitamin D3 | 100 | 1.0 |
| 25 OH Vitamin D2 | 30 | 104.5 |
| 25 OH Vitamin D3 | 30 | 100.7 |
| Paricalcitol | 24 | 0.1 |
| 3-epi-25-OH Vitamin D3 | 100 | 1.1 |
| Vitamin D2 | 1000 | 0.5 |
| Vitamin D3 | 1000 | 0.3 |
Interfering Substances
Interfering substances were tested as described in CLSI Document EP7-A2 using the ADVIA Centaur VitD assay.
| Specimens That Are | Demonstrate ≤ 10% Change in Results Up To |
|---|---|
| hemolyzed | 155 mg/dL of hemoglobin |
| lipemic | 540 mg/dL of triglycerides |
| icteric | 40 mg/dL of conjugated bilirubin |
| icteric | 40 mg/dL of unconjugated bilirubin |
| Specimens That Contain | Demonstrate ≤ 10% Change in Results Up To |
| cholesterol | 350 mg/dL |
| uric acid | 20 mg/dL |
| human immunoglobulin | 12 g/dL |
Correlation
(y =ADVIA Centaur Vitamin D assay vs. x = IDS 25-OH Vitamin D EIA assay comparison method/system)
| IDS vs Centaur | |||||
|---|---|---|---|---|---|
| X Axis | Y Axis | n | r | Slope | Y-int |
| IDS | Centaur VitD | 195 | .960 | 1.0 | +2.22 |
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Serum / Plasma (lithium heparin and EDTA)
The ADVIA Centaur VITD assay was evaluated using different sample matrices and tube collection types. A matrix study was performed using matched specimens drawn in different tube types,including serum red top, SST, EDTA, lithium heparin, and sodium heparin. Vitamin D values ranged from 11.9 to 136.9 ng/mL (29.8 to 342.3 nmol/L). Linear regression analysis was performed using the following:
- · serum (x) vs. SST (y1)
- · serum (x) vs. EDTA (y2)
- · serum (x) vs. lithium heparin (y3)
- · serum (x) vs. sodium heparin (y4)
No significant differences between tube types was observed. The following results were obtained:
| Tube Types | N | Range(ng/mL) | Slope | Intercept | R |
|---|---|---|---|---|---|
| Serum vs. SST | 231 | 11.9 - 136.9 | 1.01 | -0.33 | 0.994 |
| Serum vs. EDTA | 231 | 11.9 - 136.9 | 1.09 | -0.17 | 0.993 |
| Serum vs. Lithium Heparin | 231 | 11.9 - 136.9 | 1.04 | 0.18 | 0.992 |
| Serum vs. Sodium Heparin | 231 | 11.9 - 136.9 | 1.04 | 0.90 | 0.992 |
Conclusions:
The Siemens Healthcare Diagnostics ADVIA Centaur Vitamin D Total assay (including calibrators and controls) is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed IDS 25-Hydroxy Vitamin D EIA (K021163).
The Siemens Healthcare Diagnostics ADVIA Centaur Vitamin D Total assay MCMs are substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed VALIDATE Thyroid Calibration Verification Test Set (K062501).
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Image /page/10/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The eagle is black, and the text is also black.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Healthcare Diagnostics, Inc. c/o Mr. Neil Parker 511 Benedict Avenue Tarrytown, New York 10509
OCT 1 4 2011
Re: K110586
Trade Name: ADVIA Centaur Vitamin D Total (VitD) Assay ADVIA Centaur Vitamin D Total (VitD) Calibrators ADVIA Centaur Vitamin D Total (VitD) QC ADVIA Centaur Vitamin D Total (VitD) Master Curve Material Regulation Number: 21 CFR §862.1825 Regulation Name: Vitamin D Test System Regulatory Class: Class II Product Codes: MRG, JIS, JIX Dated: September 15, 2011 Received: September 16, 2011
Dear Dr. Neil Parker,
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 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/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of 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 vours.
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ADVIA Centaur Vitamin D Total Assay Indication for Use:
The ADVIA Centaur Vitamin D Total (VitD) assay is for in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium-heparin, sodium-heparin) using the ADVIA Centaur XP system. The ADVIA Centaur VitD assay is intended as an aid in the determination of vitamin D sufficiency.
The ADVIA Centaur Vitamin D Total (VitD) Calibrators is for in vitro diagnostic use in calibrating ADVIA Centaur® systems Vitamin D Total (VitD) assay.
The ADVIA Centaur Vitamin D Total (VitD) QC is for in vitro diagnostic use to monitor the precision and accuracy of the ADVIA Centaur® VitD assay on the ADVIA Centaur systems.
The ADVIA Centaur® Vitamin D Total (VitD) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur VitD assay.
Prescription Use X_ (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
CARS
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110586.
Page 1 of
§ 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.