(116 days)
The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total 25-hydroxyvitamin D [25(OH) vitamin D] levels in human serum and plasma using the UniCel DxI Immunoassay Systems. Results are to be used as an aid in the assessment of vitamin D sufficiency.
The Access 25(OH) Vitamin D Total Calibrators are intended to calibrate the Access 25(OH) Vitamin D Total assay for the quantitative determination of total 25-hydroxyvitamin D [25(OH) vitamin D] levels in human serum and plasma using the UniCel DxI Immunoassay Systems.
The Access 25(OH) Vitamin D Total for use on the UniCel DxI Immunoassay System, The Access 25(OH) Vitamin D Total Calibrators for use on the UniCel DxI Immunoassay System, and the UniCel DxI Immunoassay analyzer comprise the Access Immunoassay System for the quantitative determination of total 25-hydroxyvitamin D [25(OH) vitamin D] levels in human serum and plasma.
The Access 25(OH) Vitamin D Total assay is a two-step sequential competitive binding immunoenzymatic assay. In the initial incubation, sample is added to a reaction vessel with a vitamin D binding protein (DBP) releasing agent and paramagnetic particles coated with sheep monoclonal anti-25(OH) vitamin D antibody. 25(OH) vitamin D is released from DBP and binds to the immobilized monoclonal anti-25(OH) vitamin D on the solid phase. Subsequently, a 25(OH) vitamin D analogue-alkaline phosphatase conjugate is added which competes for binding to the immobilized monoclonal anti-25(OH) vitamin D. After a second incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate Lumi-Phos 530 is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is inversely proportional to the concentration of 25(OH) vitamin D in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve.
The provided text describes the Beckman Coulter Access 25(OH) Vitamin D Total assay, an in vitro diagnostic immunoassay system cleared by the FDA through the 510(k) pathway. This pathway establishes substantial equivalence to a predicate device, rather than proving a new device meets specific acceptance criteria based on established ground truth in the same way a de novo or PMA would. Therefore, the information provided focuses on comparative performance against a predicate and a reference method, rather than pre-defined acceptance criteria against a clinical ground truth.
Here's an interpretation of the available information regarding acceptance criteria and supporting studies, framed as closely as possible to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, the "acceptance criteria" are implied by the need to demonstrate substantial equivalence to the predicate device and acceptable analytical performance. The document doesn't explicitly state "acceptance criteria" numerical targets in the same way a clinical trial might, but rather describes the results of analytical studies showing performance characteristics.
| Performance Metric | Implied "Acceptance Criteria" (Demonstrate equivalence / acceptable analytical performance) | Reported Device Performance (Access 25(OH) Vitamin D Total) |
|---|---|---|
| Method Comparison (vs. Predicate) | Strong correlation with predicate device | Correlation coefficient of 0.88 (Passing-Bablok analysis) |
| Method Comparison (vs. Reference Method) | Strong correlation with Reference Measurement Procedure (RMP) | Slope of 0.99 and correlation coefficient of 0.94 (vs. NIST-Ghent ID-LC-MS/MS RMP) |
| Imprecision (Total CV) | ≤ 10.0% for concentrations > 15.0 ng/mL | Ranged from 4.2% to 9.3% |
| Imprecision (Total SD) | ≤ 1.5 ng/mL for concentrations ≤ 15.0 ng/mL | Ranged from 0.7 to 1.3 ng/mL |
| Linearity | Demonstrate linearity across the measuring range | Demonstrated linearity from 7.0 ng/mL to 120 ng/mL |
| Limit of Blank (LoB) | Established LoB for assay | 1.50 ng/mL (Highest observed with no analyte: 0.98 ng/mL) |
| Limit of Detection (LoD) | Established LoD for assay | 2.00 ng/mL (Lowest detectable with 95% probability: 1.47 ng/mL) |
| Limit of Quantitation (LoQ) | Established LoQ for assay (e.g., %CV of 20%) | 7.0 ng/mL (Lowest quantifiable with 20% CV: 4.4 ng/mL) |
| Analytical Specificity (Interference) | No significant interference from normal blood constituents/common medications | No interference from normal human blood constituents and common medications; Hemoglobin up to 0.5 g/L without interference |
| Cross Reactivity | Limited or acceptable cross-reactivity | Paricalcitol caused falsely elevated results; other cross-reactants did not cause interference |
2. Sample Size and Data Provenance
- Test Set for Method Comparison (vs. Predicate): 278 samples
- Test Set for Method Comparison (vs. Reference Method): 110 samples
- Test Set for Imprecision: Specific sample numbers not explicitly stated, but "representative studies" were performed with multiple concentrations.
- Test Set for LoB, LoD, LoQ, Linearity, Analytical Specificity, Cross Reactivity: Not explicitly stated as "test sets" with distinct sample counts, but rather as results from specific analytical experiments.
- Population Observation Group (for typical concentration range): 367 apparently healthy male and female adults.
- Data Provenance: The document does not explicitly state the country of origin for the samples. The studies are described as analytical validation studies performed by the manufacturer (Beckman Coulter). The reference method (NIST-Ghent ID-LC-MS/MS) suggests an international reference, but the origin of the samples used in comparison to it is not specified. The context of a US FDA submission suggests the intent for US regulatory compliance. The studies are prospective in nature, as they involve testing the device's performance characteristics.
3. Number of Experts and their Qualifications for Ground Truth
- For Method Comparison (vs. Predicate): The "ground truth" is effectively the results obtained from the predicate device (DiaSorin LIAISON 25 OH Vitamin D Total Assay). This predicate device's performance would have been established previously, but no expert review of its results is mentioned for this study.
- For Method Comparison (vs. Reference Method): The "ground truth" is the NIST-Ghent ID-LC-MS/MS Reference Measurement Procedure (RMP). This is a highly accurate and standardized analytical method, a "gold standard" in laboratory measurement, and does not involve human expert interpretation in the diagnostic sense (like a radiologist reading an image). It's a laboratory-based, instrumental reference method.
- For other analytical studies (Imprecision, Linearity, LoB, LoD, LoQ, Specificity, Cross-reactivity): The "ground truth" is defined by the experimental setup and the known concentrations or characteristics of the samples used (e.g., control samples with known concentrations, samples spiked with interferents). No human experts are used to establish ground truth in this context.
4. Adjudication Method for the Test Set
Not applicable. Diagnostic immunoassay studies for 510(k) clearance typically do not involve human adjudication in the way clinical studies for imaging or histology might. The "ground truth" is based on the performance of a reference method or predetermined analytical characteristics.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study (MRMC, human-in-the-loop performance) is not applicable to an automated immunoassay device. The device provides a quantitative numerical result, not an interpretation that radiologists or other human readers would perform.
6. Standalone (Algorithm Only) Performance
Yes, the studies described are standalone performance evaluations of the Access 25(OH) Vitamin D Total assay. The device itself performs the measurement and produces the result without human intervention for interpretation beyond operating the instrument and collecting the sample.
7. Type of Ground Truth Used
- Predicate Device Performance: For the primary substantial equivalence comparison.
- Reference Measurement Procedure (RMP): Specifically, the NIST-Ghent ID-LC-MS/MS for the 25(OH) Vitamin D ID LC-MS/MS (a highly accurate and standardized laboratory method). This is considered a highly reliable analytical "ground truth".
- Known Sample Characteristics: For analytical characteristics like linearity, limits of detection/quantitation, specificity, and cross-reactivity, ground truth is established by using control materials, spiked samples, or samples with otherwise analytically verified characteristics.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. This immunoassay system is a hardware-based diagnostic device with chemical reagents, and its "training" refers to its analytical calibration and development, not algorithm training.
The closest analogy would be the samples used to develop and refine the assay's performance characteristics and define its calibration curve. However, specific numbers for this purpose are not provided. The development process would involve numerous samples, but these are distinct from a "training set" as understood in a machine learning context.
9. How the Ground Truth for the Training Set was Established
As discussed above, an explicit "training set" with ground truth in the AI sense is not applicable. The assay is based on established chemiluminescent immunoassay principles. The "calibration curve" for the device is established using calibrators with known concentrations of 25(OH) Vitamin D. These calibrator concentrations would be precisely determined through highly accurate reference methods, likely similar to the NIST-Ghent ID-LC-MS/MS RMP. The document states "The Access 25(OH) Vitamin D Total Calibrators are intended to calibrate the Access 25(OH) Vitamin D Total assay," and list 6 calibrator levels (0, 6, 17, 37, 87, and 210 ng/mL) containing human serum with 25(OH) vitamin D. The ground truth for these calibrators would be established through a rigorous metrological chain to a primary reference standard.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
BECKMAN COULTER, INC. RYAN SEVERSON SENIOR REGULATORY AFFAIRS ANALYST 1000 LAKE HAZELTINE DR. CHASKA MN 55318-1084
December 19, 2014
Re: K142362
Trade/Device Name: Access 25(OH) Vitamin D Total for use on the Unicel DxI Immunoassay System Access 25(OH) Vitamin D Total Calibrators for use on the UniCel DxI Immunoassay System Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: II Product Code: MRG, JIT Dated: November 13, 2014
Received: November 14, 2014
Dear Mr. Ryan Severson:
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
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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 (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for 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 Industry and Consumer Education 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.
Sincerely yours,
Katherine Serrano -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
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Indications for Use
510(k) Number (if known) K142362
Device Name
Access 25(OH) Vitamin D Total for use on the UniCel DxI Immunoassay Systems.
Access 25(OH) Vitamin D Total Calibrators for use on the UniCel DxI Immunoassay Systems.
Indications for Use (Describe)
The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total 25-hydroxyvitamin D [25(OH) vitamin D] levels in human serum and plasma using the UniCel DxI Immunoassay Systems. Results are to be used as an aid in the assessment of vitamin D sufficiency.
The Access 25(OH) Vitamin D Total Calibrators are intended to calibrate the Access 25(OH) Vitamin D Total assay for the quantitative determination of total 25-hydroxyvitamin DJ levels in human serum and plasma using the UniCel DxI Immunoassay Systems.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Administrative Section 3.2: 510(k) Summary
510(k) Summary
Prepared August 22, 2014
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
The Assigned 510(k) Number is: _______________________________________________________________________________________________________________________________________________
Submitted By:
Ryan Severson Senior Regulatory Affairs Analyst Beckman Coulter Inc. 1000 Lake Hazeltine Dr. Chaska, MN, 55318 Phone: (952) 368-7899 Fax: (952) 368-7610 Email: rmseverson@beckman.com
Device Name
| Proprietary/Trade Name: | Access 25(OH) Vitamin D Total for use on the UniCel DxI | |
|---|---|---|
| Immunoassay System. | ||
| Common Name: | 25(OH) Vitamin D | |
| Classification Name: | Vitamin D Test System | |
| Classification Regulation: | 21 CFR 862.1825 | |
| Product Code: | MRG | |
| Proprietary/Trade Name: | Access 25(OH) Vitamin D Total Calibrators for use on the | |
| UniCel DxI Immunoassay System. | ||
| Common Name: | 25(OH) Vitamin D Calibrators | |
| Classification Name: | Calibrator, Secondary | |
| Classification Regulation: | 21 CFR 862.1150 | |
| Product Code: | JIT |
Predicate Device
DiaSorin LIAISON 25 OH Vitamin D Total Assay (K112725). DiaSorin LIAISON 25 OH Vitamin D Total Calibrators (K112725) Manufactured by Diasorin, Inc.
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Device Description
The Access 25(OH) Vitamin D Total for use on the UniCel DxI Immunoassay System, The Access 25(OH) Vitamin D Total Calibrators for use on the UniCel DxI Immunoassay System, and the UniCel DxI Immunoassay analyzer comprise the Access Immunoassay System for the quantitative determination of total 25-hydroxyvitamin D [25(OH) vitamin D] levels in human serum and plasma.
The Access 25(OH) Vitamin D Total assay is a two-step sequential competitive binding immunoenzymatic assay. In the initial incubation, sample is added to a reaction vessel with a vitamin D binding protein (DBP) releasing agent and paramagnetic particles coated with sheep monoclonal anti-25(OH) vitamin D antibody. 25(OH) vitamin D is released from DBP and binds to the immobilized monoclonal anti-25(OH) vitamin D on the solid phase. Subsequently, a 25(OH) vitamin D analogue-alkaline phosphatase conjugate is added which competes for binding to the immobilized monoclonal anti-25(OH) vitamin D. After a second incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate Lumi-Phos 530 is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is inversely proportional to the concentration of 25(OH) vitamin D in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve.
Intended Use
The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total 25-hydroxyvitamin D [25(OH) vitamin D] levels in human serum and plasma using the UniCel DxI Immunoassay Systems. Results are to be used as an aid in the assessment of vitamin D sufficiency.
The Access 25(OH) Vitamin D Total Calibrators are intended to calibrate the Access 25(OH) Vitamin D Total assay for the quantitative determination of total 25hydroxyvitamin D [25(OH)vitamin D] levels in human serum and plasma using the UniCel DxI Immunoassay Systems.
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Comparison of Technological Characteristics
| Parameter | Diasorin 25 OH Vitamin D Total. | Access 25(OH) Vitamin D Total |
|---|---|---|
| Intended Use | The LIAISON® 25 OH Vitamin DTOTAL Assay useschemiluminescent immunoassay(CLIA) technology for thequantitative determination of 25-hydroxyvitamin D and otherhydroxylated vitamin D metabolitesin human serum, to be used in theassessment of vitamin D sufficiencyusing the LIAISON® Analyzerfamily. Assay results should beused in conjunction with otherclinical or laboratory data to assistthe clinician in making individualpatient management decisions in anadult population. | The Access 25(OH) Vitamin DTotal assay is a paramagneticparticle, chemiluminescentimmunoassay for the quantitativedetermination of total 25-hydroxyvitamin D [25(OH)vitamin D] levels in humanserum and plasma using theUniCel DxI ImmunoassaySystem. Results are to be used asan aid in the assessment ofvitamin D sufficiency. |
| Analyte Measurand | 25(OH) Vitamin D | 25(OH) Vitamin D |
| Standardization | Standard prep: UV ε | NIST-Ghent ID-LC-MS/MS |
| Technology | Competitive Immunoassay | Competitive Immunoassay |
| Format | Chemiluminescent | Chemiluminescent |
| Method | Automated | Automated |
| Calibration | Utilizes a stored calibration curve. | Utilizes a stored calibration curve |
| Sample Type | Serum | Serum/Li Hep Plasma |
| Measuring Range | 4-150 ng/mL | 7.0-120 ng/mL (17.5 to 300nmol/L). |
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Summary of Studies
Method Comparison: A comparison of 25 (OH) Vitamin D concentrations from 278 samples, ranging from 7.32 ng/mL to 119.99 ng/mL was run on both the Access 25(OH) Vitamin D Total assay and the predicate DiaSorin LIAISON 25 OH Vitamin D Total. The new method was correlated with the predicate using Passing-Bablok analysis and the observed correlation coefficient was 0.88. A secondary comparison of 110 samples, ranging from 8.0 ng/mL to 98.6 ng/mL (20 nmol/L to 246.5 nmo//L), was completed on the Access 25(OH) Vitamin D Total assay and the 25(OH) Vitamin D ID LC-MS/MS Reference Measurement Procedure (RMP) from Ghent University (Ghent RMP). Analysis was completed using Passing Bablock, and the observed slope and correlation coefficient were 0.99 and 0.94 respectively.
Imprecision: This assay exhibits total imprecision ≤ 10.0% at concentrations greater than 15.0 ng/mL and Standard Deviation (SD) ≤ 1.5 ng/mL at concentrations ≤ 15.0 ng/mL. Representative studies demonstrated that the within-run % CV ranged from 2.1 to 4.7 %. the between-run % CV ranged from 3.3% to 8.1%, and the total % CV ranged from 4.2% to 9.3% for 25(OH) Vitamin D (250HD) concentrations > 15.0 ng/mL. The within-run SD ranged from 0.4 to 0.8 ng/mL, the between-run SD ranged from 0.6 to 1.2 ng/mL, and the total SD ranged from 0.7 to 1.3 ng/mL for 250HD concentrations < 15.0 ng/mL.
Linearity: The results indicate that the Access 25(OH) Vitamin D Total assay demonstrates linearity across the measuring range from 7.0 ng/mL ~ 120 ng/mL.
Limit of Blank (LoB): For the purposes of the assay Instructions for Use, the LOB will be 1.50 ng/mL. Representative data showed that the highest measurement result observed with no analyte present was determined to be 0.98 ng/mL.
Limit of Detection (LoD): For the purposes of the assay Instructions for Use, the LOD will be 2.00 ng/mL. Representative data showed that the lowest concentration of analyte in a sample that can be detected with a stated probability (95%) was determined to be 1.47 ng/mL.
Limit of Quantitation (LoQ): For the purposes of the assay Instructions for Use, the LOQ will be 7.0 ng/mL. Representative data showed that the lowest concentration in a sample that can be quantitatively determined with a % CV of 20% was determined to be 4.4 ng/mL.
Analytical Specificity: Normal human blood constituents and commonly encountered medications do not cause interference in the Access 25 (OH) Vitamin D Total Assay. Hemoglobin does not cause interference in the Access 25 (OH) Vitamin D Total Assay up to 0.5 g/L.
Cross Reactivity: Cross-reactants do not cause interference in the Access 25 (OH) Vitamin D Assay, with the exception of Paracalcitol. Cross reactivity studies indicate that falsely elevated results may occur in patients being treated with Paricalcitol.
Population Observation Group: This study measured 25(OH) vitamin D in serum samples from 367 apparently healthy male and female adults 21 years of age and older. The concentrations of 25(OH) vitamin D found in this population was from 11.5-84.5 ng/mL.
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Substantial Equivalence Comparison
Beckman Coulter believes the Access 25(OH) Vitamin D Total assay is substantially equivalent to the DiaSorin LIAISON 25 OH Vitamin D Total Assay (K112725). Tables 2 and 3 provide a summary of the pertinent similarities and differences between these two devices:
| Table 2: Substantial Equivalence Comparison - Similarities | ||
|---|---|---|
| Characteristic | DiaSorin LIAISON 25 OHVitamin D Total Assay(predicate, CalibratorsIncluded) | Access 25(OH) Vitamin D Total forUse on the UniCel DxI ImmunoassaySystem Reagent and Access 25(OH)Vitamin D Total Calibrators for Use onthe UniCel DxI Immunoassay System. |
| Reagent | ||
| 510(k) Number(s) | K112725 | |
| Intended Use | The LIAISON® 25 OHVitamin D TOTAL Assay useschemiluminescentimmunoassay (CLIA)technology for the quantitativedetermination of 25-hydroxyvitamin D and otherhydroxylated vitamin Dmetabolites in human serum,to be used in the assessment ofvitamin D sufficiency usingthe LIAISON® Analyzerfamily. Assay results shouldbe used in conjunction withother clinical or laboratorydata to assist the clinician inmaking individual patientmanagement decisions in anadult population. | The Access 25(OH) Vitamin D Totalassay is a paramagnetic particle,chemiluminescent immunoassay for thequantitative determination of total 25-hydroxyvitamin D [25(OH) vitamin D]levels in human serum and plasma usingthe UniCel DxI Immunoassay Systems.Results are to be used as an aid in theassessment of vitamin D sufficiency.The Access 25(OH) Vitamin D TotalCalibrators are intended to calibrate theAccess 25(OH) Vitamin D Total assayfor the quantitative determination oftotal 25-hydroxyvitamin D [25(OH)D]levels in human serum and plasma usingthe UniCel DxI Immunoassay Systems. |
| Format | Chemiluminescentimmunoassay | Same |
| Method | Automated | Same |
| Product Type | Reagent | Same |
| Assay | Calibrators | Same |
| Components | Reagent Pack | Same |
| Calibration | Utilizes a stored calibrationcurve | Same |
| Table 2: Substantial Equivalence Comparison - Similarities | ||
| Characteristic | DiaSorin LIAISON 25 OHVitamin D Total Assay(predicate, CalibratorsIncluded) | Access 25(OH) Vitamin D Total forUse on the UniCel DxI ImmunoassaySystem Reagent and Access 25(OH)Vitamin D Total Calibrators for Use onthe UniCel DxI Immunoassay System. |
| Reportable units | ng/mL | ng/mL (nmol/L) |
| Assay type | Competition (direct);piggyback competition | 2 Step Piggyback Competition assay |
| Calibrators | ||
| 510(k) Number(s) | K112725 | |
| Material | Human Serum. | Same |
| Method | Automated | Same |
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The intended use, assay principal, test system, reagent pack configuration, assay method, assay type, and assay components of the subject device are equivalent to those of the predicate device.
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| Table 3: Substantial Equivalence Comparison - Differences | ||
|---|---|---|
| Characteristic | DiaSorin LIAISON 25 OH VitaminD Total Assay (predicate,Calibrators Included) | Access 25(OH) Vitamin DTotal for Use on the UniCelDxI Immunoassay SystemReagent and Access 25(OH)Vitamin D Total Calibratorsfor Use on the UniCel DxIImmunoassay System. |
| Reagent | ||
| Sample Type | Serum | Serum/Li Hep Plasma |
| Immunoassayinstrument | DiaSorin LIAISON | UniCel DxI ImmunoassaySystem |
| Capture Antibody | Polyclonal Goat Aby (anti 25 OH VitD) | Sheep monoclonal anti-25(OH) vitamin D |
| Sample Volume (µL) | 250 for first run (25 for additionalruns) | 30 |
| Analytical MeasuringRange (ng/mL) | 4-150 | 7.0 -120 |
| Standardization | Standard prep: UV ε | NIST-Ghent ID-LC-MS/MS |
| Calibrators | ||
| Calibrator Levels | 2 | 6 |
| Calibrator Materials | 25-OH-D Horse serum, phosphate,surfactants, NaN3 | Human Serum with 25(OH)vitamin D |
| Calibrator Number | 2 cal levels (Low, high) | 6 levels, zero andapproximately 6, 17, 37, 87and 210 ng/mL. (0, 15, 43,93, 218 and 525 nmol/L)) |
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Conclusion
The information provided in the sections cited above demonstrates that the proposed new device, the Access 25(OH) Vitamin D Total assay has the same intended use as the predicate device. In addition, verification and validation testing, the clinical and analytical data, and other scientific information provided in this submission demonstrate that the Access 25(OH) Vitamin D Total assay on the UniCel DxI Immunoassay System is substantially equivalent to the predicate device. This information establishes the substantial equivalence of Beckman Coulter's product to the predicate device.
§ 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.