(119 days)
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No
The description details a standard immunoassay process and analyzer, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is an in vitro diagnostic (IVD) immunoassay system used for the quantitative determination of total 25-hydroxyvitamin D levels in human serum and plasma, aiding in the assessment of vitamin D sufficiency. It does not provide therapy or treatment.
Yes
Explanation: The Access 25(OH) Vitamin D Total assay "is to be used as an aid in the assessment of vitamin D sufficiency," which is a diagnostic purpose.
No
The device description explicitly states that the system comprises the Access 25(OH) Vitamin D Total assay, the Access 25(OH) Vitamin D Total Calibrators, and the Access 2 Immunoassay analyzer. The assay itself is a "two-step sequential competitive binding immunoenzymatic assay" involving paramagnetic particles and chemiluminescent substrate, which are physical components. The analyzer is also a hardware component. Therefore, this is not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of total 25-hydroxyvitamin D [25(OH) vitamin D] levels in human serum and plasma." This involves testing biological samples in vitro (outside the body).
- Device Description: The description details a "paramagnetic particle, chemiluminescent immunoassay" and the use of "human serum and plasma" as samples. This is a typical description of an in vitro diagnostic test.
- Function: The device measures the concentration of a substance (25(OH) vitamin D) in a biological sample to provide information about a person's health status ("aid in the assessment of vitamin D sufficiency"). This is the core function of an IVD.
- Components: The system includes reagents (assay and calibrators) and an analyzer designed to perform the test on biological samples. These are components of an IVD system.
- Performance Studies: The performance studies described (Method Comparison, Imprecision, Linearity, Limits of Detection/Quantitation, Analytical Specificity, Cross Reactivity, Population Observation Group) are standard types of studies conducted to validate the performance of an IVD.
- Predicate Device: The predicate device listed (DiaSorin LIAISON 25 OH Vitamin D Total Assay) is also an IVD, indicating that this device is intended for a similar diagnostic purpose.
All of these factors strongly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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 25-hydroxyvitamin D [25(OH) vitamin D] levels in human serum and plasma using the Access 2 Immunoassay Systems.
Product codes (comma separated list FDA assigned to the subject device)
MRG, JIT
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, rendered in a dark color.
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
1
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
2
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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3
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 2
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
Access 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.
4
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.
5
Comparison of Technological Characteristics
| Parameter | Diasorin 25 OH Vitamin D Total. | Access 25(OH) Vitamin D Total |
|---|---|---|
| Intended Use | The LIAISON® 25 OH Vitamin D | |
| TOTAL Assay uses | ||
| chemiluminescent immunoassay | ||
| (CLIA) technology for the | ||
| quantitative determination of 25- | ||
| hydroxyvitamin D and other | ||
| hydroxylated vitamin D | ||
| metabolites in human serum, to be | ||
| used in the assessment of vitamin D | ||
| sufficiency using the LIAISON® | ||
| Analyzer family. Assay results | ||
| should be used in conjunction with | ||
| other clinical or laboratory data to | ||
| assist the clinician in making | ||
| individual patient management | ||
| decisions in an adult population. | 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 System. Results are | ||
| to be used as an aid in the | ||
| assessment of vitamin D | ||
| sufficiency. | ||
| 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 |
| Measuring | ||
| Range | 4-150 ng/mL | 7.0-120 ng/mL (17.5 to 300 |
| nmol/L) |
6
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 OH | |
| Vitamin D Total Assay | ||
| (predicate, Calibrators | ||
| Included) | Access 25(OH) Vitamin D Total for | |
| Use on the Access 2 Immunoassay | ||
| System Reagent and Access 25(OH) | ||
| Vitamin D Total Calibrators for Use | ||
| on the Access 2 Immunoassay | ||
| System. | ||
| Reagent | ||
| 510(k) Number(s) | K112725 | |
| Intended Use | The LIAISON® 25 OH | |
| Vitamin D TOTAL Assay | ||
| uses chemiluminescent | ||
| immunoassay (CLIA) | ||
| technology for the | ||
| quantitative determination | ||
| of 25-hydroxyvitamin D and | ||
| other hydroxylated vitamin | ||
| D metabolites in human | ||
| serum, to be used in the | ||
| assessment of vitamin D | ||
| sufficiency using the | ||
| LIAISON® Analyzer | ||
| family. Assay results should | ||
| be used in conjunction with | ||
| other clinical or laboratory | ||
| data to assist the clinician in | ||
| making individual patient | ||
| management decisions in an | ||
| adult population. | 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)D] levels
in human serum and plasma using
the Access 2 Immunoassay Systems. |
| Format | Chemiluminescent
immunoassay | Same |
| Method | Automated | Same |
| Table 2: Substantial Equivalence Comparison - Similarities | | |
| Characteristic | DiaSorin LIAISON 25 OH
Vitamin D Total Assay
(predicate, Calibrators
Included) | Access 25(OH) Vitamin D Total for
Use on the Access 2 Immunoassay
System Reagent and Access 25(OH)
Vitamin D Total Calibrators for Use
on the Access 2 Immunoassay
System. |
| 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 calibration
curve | Same |
| Table 3: Substantial Equivalence Comparison - Differences | | |
| Characteristic | DiaSorin LIAISON 25 OH Vitamin
D Total Assay (predicate,
Calibrators Included) | Access 25(OH) Vitamin D
Total for Use on the Access 2
Immunoassay System
Reagent and Access 25(OH)
Vitamin D Total Calibrators
for Use on the Access 2
Immunoassay System. |
| | Reagent | |
| Sample Type | Serum | Serum/Li Hep Plasma |
| Immunoassay
instrument | DiaSorin LIAISON | Access 2 Immunoassay
System |
| Capture Antibody | Polyclonal Goat Aby (anti 25 OH
Vit D) | Sheep monoclonal anti-
25(OH) vitamin D |
| Sample Volume (µL) | 250 for first run (25 for additional
runs) | 30 |
| Analytical Measuring
Range (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 and
approximately 7, 18, 35, 74
and 167 ng/mL. (0, 18, 45,
88, 185 and 418 nmol/L)) |
8
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.
9
10
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.