(116 days)
DiaSorin LIAISON 25 OH Vitamin D Total Assay (K112725)
Not Found
No
The device description and performance studies detail a standard immunoassay technology and do not mention any AI or ML components.
No
The device is an in vitro diagnostic immunoassay system used to quantitatively determine total 25-hydroxyvitamin D levels, which aids in assessing vitamin D sufficiency. It does not directly treat or prevent any condition.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the results are 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 an assay, calibrators, and an immunoassay analyzer, which is a hardware component. The description of the assay process also details chemical reactions and measurements taken by a luminometer, further indicating hardware involvement.
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 (serum and plasma) in vitro (outside the body).
- Device Description: The description details a "paramagnetic particle, chemiluminescent immunoassay" and a "two-step sequential competitive binding immunoenzymatic assay". These are laboratory-based testing methods performed on biological samples.
- Performance Studies: The document describes various performance studies like Method Comparison, Imprecision, Linearity, Limit of Blank, Limit of Detection, Limit of Quantitation, Analytical Specificity, and Cross Reactivity. These are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device(s)" with K numbers (K112725) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
All these elements clearly point to the device being used to perform diagnostic testing on biological samples outside of the body, which is the definition of an In Vitro Diagnostic device.
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 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.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The predicate device specifies "adult population". The subject device does not explicitly specify.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
§ 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 seal for the Department of Health & Human Services (USA). The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.
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 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 | ||
| UniCel DxI Immunoassay | ||
| System. Results are to be used as | ||
| an aid in the assessment of | ||
| vitamin 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 300 |
| nmol/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