(58 days)
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No
The summary describes a standard immunoassay for measuring vitamin D levels and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
This device is an immunoassay designed for the quantitative determination of 25-hydroxyvitamin D levels in human serum and plasma to aid in assessing vitamin D sufficiency. It is an in vitro diagnostic device, not a therapeutic device.
Yes
The "Intended Use / Indications for Use" states that the assay provides "quantitative determination of total 25-hydroxyvitamin D [25(OH) vitamin D] levels in human serum and plasma" and that "Results are to be used as an aid in the assessment of vitamin D sufficiency," which are diagnostic purposes.
No
The device description explicitly states that the device consists of a reagent pack and calibrators, which are physical components used in a chemiluminescent immunoassay. It also mentions the need for substrate and wash buffer, and its use with a specific immunoassay analyzer (DxI 9000 Access Immunoassay Analyzer). This indicates it is a hardware-based assay system, not a software-only 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).
- Indications for Use: The results are used "as an aid in the assessment of vitamin D sufficiency," which is a diagnostic purpose.
- Device Description: It describes a "paramagnetic particle, chemiluminescent immunoassay" and components like "reagent pack and calibrators," which are typical for laboratory diagnostic tests.
- Care Setting: It is designed for use "in a clinical laboratory setting," where IVD tests are performed.
- Performance Studies: The document details performance studies like Method Comparison, Precision, Linearity, Limit of Blank, Limit of Detection, and Limit of Quantitation, which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K142373) indicates a comparison to a previously cleared IVD device, a common practice in the regulatory submission process for IVDs.
All these factors align with the definition and characteristics 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 DxI Access Immunoassay Analyzers. Results are to be used as an aid in the assessment of vitamin D sufficiency.
Product codes (comma separated list FDA assigned to the subject device)
MRG
Device Description
The Access 25(OH) Vitamin D Total assay is a competitive binding immunoenzymatic assay. The Access 25(OH) Vitamin D Total assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access 25(OH) Vitamin D Total assay reagent pack, Access 25(OH) Vitamin D Total assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassav Analyzer in a clinical laboratory setting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratory setting.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison: A method comparison study was performed to compare the Access 25(OH) Vitamin D Total assay on the Dxl 9000 Access Immunoassay Analyzer to the predicate device. A total of one hundred fifty (150) serum samples falling within the measuring range of the Access 25(OH) Vitamin D Total assay were evaluated. The results of the within range method comparison study met the acceptance criteria of R2 ≥ 0.90 and slope 1.00 ± 0.10.
Precision: A study based on CLSI EP05-A3 performed on the Dxl 9000 Access Immunoassay Analyzer tested multiple serum samples in duplicate in 2 runs per day for a minimum of 20 days. The within-laboratory (total) % CV ranged from 4.3% to 9.0%, for Vitamin D concentrations > 15.0 ng/mL. The within-laboratory (total) SD ranged from 0.09 to 2.2 for Vitamin D concentrations ≤ 15.0 ng/mL.
Linearity: A verification study was performed to evaluate the linearity of the Access 25(OH) Vitamin D Total assay on the Dxl 9000 Access Immunoassay Analyzer based on CLSI EP06-Ed2. The Access 25(OH) Vitamin D Total assay is linear on the Dxl 9000 Access Immunoassay Analyzer throughout the analytical measuring interval of approximately 7.0-120 ng/mL
Limit of Blank (LoB): In one study, LoB was tested using a protocol based on CLSI EP17-A2. A total of 120 replicates of a zero analyte sample (Access 25(OH) Vitamin D Total Calibrator SQ) were measured using multiple reagent packs on multiple Dxl 9000 Access Immunoassay Analyzers. The LoB for Access 25(OH) Vitamin D Total assay is 2.5 ng/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Detection (LoD): In one study, LoD was tested using a protocol based on CLSI EP17-A2. Three Dxl 9000 Access Immunoassay Analyzers were used in the study design with three reagent lots and one calibrator lot. Eight to eleven serum samples containing low levels of Vitamin D analyte were prepared. Samples were tested over five days with one run per day and nine replicates per run for each pack lot. This resulted in ≥ 40 replicates minimally required for LoD estimation for each sample on each pack lot tested. The LoD estimate for the Access 25(OH) Vitamin D Total assay is 4.5 ng/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Quantitation (LoQ): In one study, LoQ was tested using a protocol based on CLSI EP17-A2. For estimation of LoQ, 10-13 serum samples containing low levels of Vitamin D analyte were measured. Samples were tested in replicates of nine per run with one run per day and five total days on each pack lot and instrument. A minimum of 40 replicates for each sample on each pack lot was tested. The maximum LoQ (≤ 20% within-lab CV) determined for the Access 25(OH) Vitamin D Total assay is 7.0 ng/mL on Dxl 9000 Access Immunoassay Analyzer.
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.
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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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
January 19, 2023
Beckman Coulter, Inc. Kate Oelberg Regulatory Affairs Manager 1000 Lake Hazeltine Drive Chaska, MN 55318-1084
Re: K223503
Trade/Device Name: Access 25(OH) Vitamin D Total Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: Class II Product Code: MRG Dated: November 21, 2022 Received: November 22, 2022
Dear Kate Oelberg:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Paula____ Paula Caposino -S Caposino -S Date: 2023.01.19
15:31:11 -05'00'
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223503
Device Name Access 25(OH) Vitamin D Total
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 DxI Access Immunoassay Analyzers. Results are to be used as an aid in the assessment of vitamin D sufficiency.
| 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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3
510 (k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number K223503 Date Prepared: 01/19/2023
Submitter Name and Address:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Primary Contact:
Kate Oelberg, Senior Staff Quality and Regulatory Affairs Email: kmoelberg@beckman.com Phone: (612) 431-7315
Alternate Contact:
Kuljeet Kaur, Requlatory Affairs Manager Email: kkaur@beckman.com Office Phone: (952) 465-1914
Trade Name: Access 25(OH) Vitamin D Total Common Name: 25(OH) vitamin D Classification Regulation: 21 CFR 862.1825 Classification Product Code: MRG
Predicate Device:
Access 25(OH) Vitamin D Total 510(k) Number K142373
Device Description
The Access 25(OH) Vitamin D Total assay is a competitive binding immunoenzymatic assay. The Access 25(OH) Vitamin D Total assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access 25(OH) Vitamin D Total assay reagent pack, Access 25(OH) Vitamin D Total assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassav Analyzer in a clinical laboratory setting.
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 Dxl Access Immunoassay Analyzers. Results are to be used as an aid in the assessment of vitamin D sufficiency.
4
Comparison of Technological Characteristics to the Predicate (Assay)
| System
Attribute/Characteristic | Predicate Access 25(OH)
Vitamin D Total assay
(K142373) run on the
Access 2 Immunoassay
System | Access 25(OH) Vitamin D
Total assay run on the Dxl
9000 Access Immunoassay
Analyzer Instrument |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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 Dxl Access
Immunoassay Analyzers. Results
are to be used as an aid in the
assessment
of
vitamin
D
sufficiency. |
| Analyte Measured | 25(OH) Vitamin D | Same |
| Traceable to | NIST-Ghent ID-LC-MS/MS | Same |
| Technology | Competitive Immunoassay | Same |
| Format | Chemiluminescent | Same |
| Method | Automated | Same |
| Calibration | Utilizes a stored calibration curve | Same |
| Sample Type | Serum/Li Hep Plasma | Same |
| Measuring Range | 7.0-120 ng/mL (17.5 to 300
nmol/L) | Same |
| Stability | 28 days after opening | Same |
| Reagent Pack
formulation and
packaging | Access Reagent Pack formulation
and packaging. | Same |
| Sample Volume | 30uL | 13uL |
| Instrument | Access 2 Immunoassay system | Dxl 9000 Access Immunoassay
Analyzer |
| Substrate | Access Substrate | Lumi-Phos PRO substrate |
| Reagent Configurations | One Configuration:
100 determinations, 2 packs, 50
tests/pack | Two Configurations:
- 100 determinations, 2 packs, 50
tests/pack (for predicate and
candidate instrument) - 200 determinations, 2 packs,
100 tests/pack (for candidate
instrument only) |
5
Standard/Guidance Document Referenced (if applicable):
CLSI EP05-A3: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Third Edition
CLSI EP06-2nd Edition : Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition
CLSI EP09c-A3: Measurement Procedure Comparison and Bias Estimation Using Patient Samples- Third Edition
Summary of Studies:
Method Comparison: A method comparison study was performed to compare the Access 25(OH) Vitamin D Total assay on the Dxl 9000 Access Immunoassay Analyzer to the predicate device. A total of one hundred fifty (150) serum samples falling within the measuring range of the Access 25(OH) Vitamin D Total assay were evaluated. The results of the within range method comparison study met the acceptance criteria of R2 ≥ 0.90 and slope 1.00 ± 0.10.
| N | Concentration
Range*
(ng/mL) | Slope | Slope
95% Cl | Intercept | Intercept
95% Cl | R |
|-----|------------------------------------|-------|-----------------|-----------|---------------------|------|
| 150 | 7.0 - 120 | 1.05 | 0.99 –
1.10 | 0.94 | 0.14 - 2.0 | 0.97 |
*Range is Access 2 values
Precison: A study based on CLSI EP05-A3 performed on the Dxl 9000 Access Immunoassay Analyzer tested multiple serum samples in duplicate in 2 runs per day for a minimum of 20 days. The within-laboratory (total) % CV ranged from 4.3% to 9.0%, for Vitamin D concentrations > 15.0 ng/mL. The within-laboratory (total) SD ranged from 0.09 to 2.2 for Vitamin D concentrations ≤ 15.0 ng/mL.
| ng/mL | | Repeatability
(Within-Run) | | Between-Run | | Between-Day | | Within-
Laboratory | | |
|----------|----|-------------------------------|-----|-------------|-----|-------------|-----|-----------------------|-----|------|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Sample 1 | 80 | 7.0 | 0.8 | 12.1 | 0.7 | 10.6 | 0.7 | 9.3 | 1.3 | 18.6 |
| Sample 2 | 80 | 15.6 | 0.9 | 5.5 | 0.6 | 3.7 | 0.9 | 6.0 | 1.4 | 9.0 |
| Sample 3 | 80 | 28 | 1.3 | 4.4 | 1.1 | 4.0 | 0.9 | 3.2 | 1.9 | 6.8 |
| Sample 4 | 80 | 71 | 1.6 | 2.3 | 1.9 | 2.6 | 1.8 | 2.5 | 3.1 | 4.3 |
| Sample 5 | 80 | 95 | 2.4 | 2.5 | 2.3 | 2.4 | 2.8 | 3.0 | 4.3 | 4.5 |
| Sample 6 | 80 | 111 | 3.1 | 2.8 | 3.2 | 2.9 | 2.1 | 1.9 | 4.9 | 4.5 |
6
Linearity: A verification study was performed to evaluate the linearity of the Access 25(OH) Vitamin D Total assay on the Dxl 9000 Access Immunoassay Analyzer based on CLSI EP06-Ed2. The Access 25(OH) Vitamin D Total assay is linear on the Dxl 9000 Access Immunoassay Analyzer throughout the analytical measuring interval of approximately 7.0-120 ng/mL
Limit of Blank (LoB): In one study, LoB was tested using a protocol based on CLSI EP17-A2. A total of 120 replicates of a zero analyte sample (Access 25(OH) Vitamin D Total Calibrator SQ) were measured using multiple reagent packs on multiple Dxl 9000 Access Immunoassay Analyzers. The LoB for Access 25(OH) Vitamin D Total assay is 2.5 ng/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Detection (LoD): In one study, LoD was tested using a protocol based on CLSI EP17-A2. Three Dxl 9000 Access Immunoassay Analyzers were used in the study design with three reagent lots and one calibrator lot. Eight to eleven serum samples containing low levels of Vitamin D analyte were prepared. Samples were tested over five days with one run per day and nine replicates per run for each pack lot. This resulted in ≥ 40 replicates minimally required for LoD estimation for each sample on each pack lot tested. The LoD estimate for the Access 25(OH) Vitamin D Total assay is 4.5 ng/mL on Dxl 9000 Access Immunoassay Analyzer.
Limit of Quantitation (LoQ): In one study, LoQ was tested using a protocol based on CLSI EP17-A2. For estimation of LoQ, 10-13 serum samples containing low levels of Vitamin D analyte were measured. Samples were tested in replicates of nine per run with one run per day and five total days on each pack lot and instrument. A minimum of 40 replicates for each sample on each pack lot was tested. The maximum LoQ (≤ 20% within-lab CV) determined for the Access 25(OH) Vitamin D Total assay is 7.0 ng/mL on Dxl 9000 Access Immunoassay Analyzer.
Other claims: The claims for the analytical specificity, reference intervals, matrix comparison are being transferred from file K142373.
Substantial Equivalence Comparison Conclusion
Beckman Coulter's Access 25(OH) Vitamin D Total assay on the Dxl 9000 Access Immunoassay Analyzer is substantially equivalent to Access 25(OH) Vitamin D Total assay on the Access 2 Immunoassay System (K142373) as demonstrated through the information and data provided in this submission. The performance testing presented in this submission provides evidence that the device is safe and effective in its intended use.