(119 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 Access 2 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 Access 2 Immunoassay Systems.
The Access 25(OH) Vitamin D Total for use on the Access 2 Immunoassay System, Access 25(OH) Vitamin D Total Calibrators for use on the Access 2 Immunoassay System, and the Access 2 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 document describes the Access 25(OH) Vitamin D Total assay for use on the Access 2 Immunoassay System. This device is intended for the quantitative determination of total 25-hydroxyvitamin D levels in human serum and plasma to aid in the assessment of vitamin D sufficiency.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" as a set of pass/fail thresholds for each metric. Instead, it presents performance characteristics from various studies, comparing them to the predicate device and in some cases, a reference method. I will infer "acceptance criteria" from typical requirements for such assays and the context of the reported results. The reported device performance is directly extracted from the "Summary of Studies" section.
| Performance Characteristic | Inferred Acceptance Criteria (Typical for IVD) | Reported Device Performance (Access 25(OH) Vitamin D Total) |
|---|---|---|
| Method Comparison (vs. Predicate) | High correlation (e.g., r > 0.90) | Correlation coefficient: 0.89 (against 279 samples, 7.48-118.83 ng/mL) |
| Method Comparison (vs. Reference Method) | High correlation and close to 1.0 slope | Slope: 1.01, Correlation coefficient: 0.95 (against 110 samples, 8.0-98.6 ng/mL) |
| Imprecision (Total CV > 15.0 ng/mL) | ≤ 10.0% | ≤ 10.0% (across studies: 5.5% to 7.5%) |
| Imprecision (Total SD ≤ 15.0 ng/mL) | ≤ 1.5 ng/mL | ≤ 1.5 ng/mL (across studies: 1.0 to 1.1 ng/mL) |
| Linearity (Measuring Range) | Linear response across the claimed range | Linear across 7.0 to 120 ng/mL |
| Limit of Blank (LoB) | Expected to be very low, below clinical significance | 1.50 ng/mL (Highest observed with no analyte: 0.55 ng/mL) |
| Limit of Detection (LoD) | Expected to be low to detect low concentrations | 2.00 ng/mL (Lowest detected with 95% probability: 1.0 ng/mL) |
| Limit of Quantitation (LoQ) | Low enough for clinical utility (e.g., %CV < 20%) | 7.0 ng/mL (Lowest with %CV of 20%: 3.0 ng/mL) |
| Analytical Specificity (Hemoglobin) | No significant interference up to a certain concentration | No interference up to 0.5 g/L |
| Analytical Specificity (Blood Constituents/Medications) | No significant interference | Normal human blood constituents and commonly encountered medications do not cause interference. |
| Cross Reactivity (Paricalcitol) | Should be noted if present | Falsely elevated results may occur in patients treated with Paricalcitol. |
| Population Observation Group (Reference Interval) | Well-defined reference interval for healthy population | 95% Reference interval: 11.9 - 43.6 ng/mL |
2. Sample sizes used for the test set and the data provenance:
- Method Comparison (vs. Predicate): 279 samples
- Method Comparison (vs. Reference Method): 110 samples
- Population Observation Group: 367 apparently healthy male and female adults.
- Provenance: Not explicitly stated beyond "human serum and plasma" and "samples from 367 apparently healthy male and female adults 21 years of age and older." It does not specify the country of origin, nor whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a an in-vitro diagnostic (IVD) device, not an image-based AI device requiring expert interpretation for ground truth.
- For the Method Comparison (vs. Reference Method): The ground truth was established by the 25(OH) Vitamin D ID LC-MS/MS Reference Measurement Procedure (RMP) from Ghent University (Ghent RMP). This is a highly precise and accurate analytical method, considered a gold standard for vitamin D measurement. It doesn't involve "experts" in the sense of clinical reviewers, but rather the highly qualified personnel operating and validating such reference laboratories.
4. Adjudication method for the test set:
Not applicable in the context of an IVD assay comparing results against a predicate device or a reference measurement procedure. The comparison is quantitative, and the "ground truth" is determined by the reference method's output.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is an in-vitro diagnostic device, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the studies presented are for the standalone performance of the Access 25(OH) Vitamin D Total assay. The device itself is an automated immunoassay system (Access 2 Immunoassay System), which operates without continuous human "in-the-loop" decision-making, producing quantitative results directly.
7. The type of ground truth used:
- For Method Comparison against predicate: The predicate device, DiaSorin LIAISON 25 OH Vitamin D Total Assay, serves as a point of comparison (proxy for ground truth in substantial equivalence claims).
- For Method Comparison against Reference Method: The 25(OH) Vitamin D ID LC-MS/MS Reference Measurement Procedure (RMP) from Ghent University (Ghent RMP) was used as the ground truth. This is a highly accurate and precise analytical method that establishes the true concentration of the analyte.
- For Imprecision, Linearity, LoB, LoD, LoQ, Analytical Specificity, Cross Reactivity: These performance characteristics are evaluated against known concentrations (spiked samples, dilutions, or samples known to be negative/positive for interferents) controlled and measured by standard laboratory methods.
8. The sample size for the training set:
Not explicitly stated. For IVD devices, a "training set" is usually not defined in the same way as machine learning models. Instead, it refers to samples used during the assay development and optimization phases. The document focuses on validation studies.
9. How the ground truth for the training set was established:
As above, the concept of a "training set" as in AI is not directly applicable. During product development and optimization (which can be analogous to training), ground truth for establishing assay parameters (e.g., antibody concentrations, incubation times, calibration curves) would be established using:
- Known concentrations of 25(OH) vitamin D (e.g., certified reference materials).
- High-fidelity reference methods like LC-MS/MS to verify initial assay performance and calibration.
- Samples with clinically confirmed vitamin D levels.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2014
BECKMAN COULTER, INC. RYAN SEVERSON SENIOR REGULATORY AFFAIRS ANALYST 1000 LAKE HAZELTINE DR. CHASKA MN 55318-1084
Re: K142373
Trade/Device Name: Access 25(OH) Vitamin D Total for use on the Access 2 Immunoassay System, Access 25(OH) Vitamin D Total Calibrators for use on the Access 2 Immunoassay System Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: II
Product Code: MRG, JIT Dated: November 17, 2014 Received: November 18, 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 vours.
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) K142373
Device Name
Access 25(OH) Vitamin D Total for use on the Access 2 Immunoassay System.
Access 25(OH) Vitamin D Total Calibrators for use on the Access 2 Immunoassay System.
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 Access 2 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 Access 2 Immunoassay Systems.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| [x] Prescription Use (Part 21 CFR 801 Subpart D) | [ ] Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 Access 2Immunoassay 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 theAccess 2 Immunoassay System. |
| Common Name: | 25(OH) Vitamin D Calibrators |
| Classification Name: | Calibrator, Secondary |
| Classification Regulation: | 21 CFR 862.1150 |
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 Access 2 Immunoassay System,
Access 25(OH) Vitamin D Total Calibrators for use on the Access 2 Immunoassay System, and the Access 2 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 Access 2 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 Access 2 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 Dmetabolites in human serum, to beused in the assessment of vitamin Dsufficiency using the LIAISON®Analyzer family. Assay resultsshould be used in conjunction withother clinical or laboratory data toassist the clinician in makingindividual patient managementdecisions in an adult population. | The Access 25(OH) Vitamin DTotal assay is a paramagneticparticle, chemiluminescentimmunoassay for the quantitativedetermination of total 25-hydroxyvitamin D [25(OH) vitaminD] levels in human serum andplasma using the Access 2Immunoassay System. Results areto be used as an aid in theassessment of vitamin Dsufficiency. |
| Analyte | 25(OH) Vitamin D | 25(OH) Vitamin D |
| Measurand | ||
| 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 |
| MeasuringRange | 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 279 samples, ranging from 7.48 ng/mL to 118.83 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 0.89. A secondary comparison of 110 samples, ranging from 8.0 ng/mL to 98.6 ng/mL (20 nmol/L to 246.5 nmol/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 1.01 and 0.95, respectively.
Imprecision: This assay exhibits total imprecision ≤ 10.0% at concentrations greater than 15.0 ng/mL and total Standard Deviation (SD) ≤ 1.5 ng/mL at concentrations ≤ 15.0 ng/mL. Representative studies demonstrated that the within-run % CV ranged from 1.4% to 2.7% , the between-run % CV ranged from 5.2% to 7.2%, and the total % CV ranged from 5.5% to 7.5% for 25(OH) Vitamin D (250HD) concentrations > 15.0 ng/mL. The within-run SD was 0.5 ng/mL across three test conditions, the between-run SD ranged from 0.9 to 1.0 ng/mL, and the total SD ranged from 1.0 to 1.1 ng/mL for 25OHD 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 to 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 0.55 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 1.0 ng/mL.
Limit of Quantitation (LoO): For the purposes of the assay Instructions for Use, the LOO 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 3.0 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 95% Reference interval of 25(OH) vitamin D concentrations found in this population range from 11.9 - 43.6 ng/mL.
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Substantial Equivalence Comparison
Beckman Coulter believes the Access 25(OH) Vitamin D Total for use on the Access 2 Immunoassay System 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 Access 2 ImmunoassaySystem Reagent and Access 25(OH)Vitamin D Total Calibrators for Useon the Access 2 ImmunoassaySystem. |
| Reagent | ||
| 510(k) Number(s) | K112725 | |
| Intended Use | The LIAISON® 25 OHVitamin D TOTAL Assayuses chemiluminescentimmunoassay (CLIA)technology for thequantitative determinationof 25-hydroxyvitamin D andother hydroxylated vitaminD metabolites in humanserum, to be used in theassessment of vitamin Dsufficiency using theLIAISON® 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 forthe quantitative determination oftotal 25-hydroxyvitamin D [25(OH)vitamin D] levels in human serumand plasma using the Access 2Immunoassay Systems. Results areto be used as an aid in the assessmentof vitamin D sufficiency.The Access 25(OH) Vitamin D TotalCalibrators are intended to calibratethe Access 25(OH) Vitamin D Totalassay for the quantitativedetermination of total 25-hydroxyvitamin D [25(OH)D] levelsin human serum and plasma usingthe Access 2 Immunoassay Systems. |
| Format | Chemiluminescentimmunoassay | Same |
| Method | Automated | 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 Access 2 ImmunoassaySystem Reagent and Access 25(OH)Vitamin D Total Calibrators for Useon the Access 2 ImmunoassaySystem. |
| Product Type | Reagent | Same |
| Assay | Calibrators | Same |
| Components | Reagent Pack | Same |
| 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 |
| Calibration | Utilizes a stored calibrationcurve | Same |
| 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 Access 2Immunoassay SystemReagent and Access 25(OH)Vitamin D Total Calibratorsfor Use on the Access 2Immunoassay System. |
| Reagent | ||
| Sample Type | Serum | Serum/Li Hep Plasma |
| Immunoassayinstrument | DiaSorin LIAISON | Access 2 ImmunoassaySystem |
| Capture Antibody | Polyclonal Goat Aby (anti 25 OHVit D) | 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 7, 18, 35, 74and 167 ng/mL. (0, 18, 45,88, 185 and 418 nmol/L)) |
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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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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 Access 2 Immunoasay 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.