Access 25(OH) Vitamin D Total

K223503 · Beckman Coulter, Inc. · MRG · Jan 19, 2023 · Clinical Chemistry

Device Facts

• Record ID: K223503
• Device Name: Access 25(OH) Vitamin D Total
• Applicant: Beckman Coulter, Inc.
• Product Code: MRG · Clinical Chemistry
• Decision Date: Jan 19, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1825
• Device Class: Class 2

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.

Device Story

Access 25(OH) Vitamin D Total assay is a competitive binding immunoenzymatic assay; utilizes paramagnetic particles and chemiluminescence. Input: human serum or plasma samples. Process: automated analysis on Dxl 9000 Access Immunoassay Analyzer; competitive binding reaction; chemiluminescent signal detection. Output: quantitative concentration of total 25-hydroxyvitamin D (ng/mL). Used in clinical laboratory settings by trained personnel. Healthcare providers use results to assess patient vitamin D sufficiency status, aiding clinical decision-making regarding supplementation or monitoring.

Clinical Evidence

Bench testing only. Method comparison study (n=150) showed R=0.97, slope 1.05 (95% CI 0.99-1.10). Precision study (CLSI EP05-A3) demonstrated within-lab CV 4.3%-9.0% for concentrations >15 ng/mL. Linearity verified 7.0-120 ng/mL. LoB=2.5 ng/mL, LoD=4.5 ng/mL, LoQ=7.0 ng/mL (CLSI EP17-A2).

Technological Characteristics

Paramagnetic particle, chemiluminescent immunoassay. Competitive binding principle. Automated operation on Dxl 9000 Access Immunoassay Analyzer. Measuring range 7.0-120 ng/mL. Traceable to NIST-Ghent ID-LC-MS/MS. Reagents include reagent pack, calibrators, Lumi-Phos PRO substrate, and wash buffer.

Indications for Use

Indicated for quantitative determination of total 25-hydroxyvitamin D in human serum and plasma to aid in assessment of vitamin D sufficiency.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 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: [e-mail] Phone: [phone]

## Alternate Contact:

Kuljeet Kaur, Requlatory Affairs Manager Email: [e-mail] Office Phone: [phone]

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.

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# Comparison of Technological Characteristics to the Predicate (Assay)

| System<br>Attribute/Characteristic | Predicate Access 25(OH)<br>Vitamin D Total assay<br>(k142373) run on the<br>Access 2 Immunoassay<br>System | Access 25(OH) Vitamin D<br>Total assay run on the Dxl<br>9000 Access Immunoassay<br>Analyzer Instrument |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/ Indications<br>for Use | The Access 25(OH) Vitamin D<br>Total assay is a paramagnetic<br>particle,<br>chemiluminescent<br>immunoassay for the<br>quantitative determination of total<br>25-hydroxyvitamin D [25(OH)<br>vitamin D] levels in human serum<br>and plasma using the<br>Access 2 Immunoassay Systems.<br>Results are to be used as an aid<br>in the assessment of vitamin D<br>sufficiency. | The Access 25(OH) Vitamin D<br>Total assay is a paramagnetic<br>particle,<br>chemiluminescent<br>immunoassay for the<br>quantitative determination of total<br>25-hydroxyvitamin D [25(OH)<br>vitamin D] levels in human serum<br>and plasma using the Dxl Access<br>Immunoassay Analyzers. Results<br>are to be used as an aid in the<br>assessment<br>of<br>vitamin<br>D<br>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<br>nmol/L) | Same |
| Stability | 28 days after opening | Same |
| Reagent Pack<br>formulation and<br>packaging | Access Reagent Pack formulation<br>and packaging. | Same |
| Sample Volume | 30uL | 13uL |
| Instrument | Access 2 Immunoassay system | Dxl 9000 Access Immunoassay<br>Analyzer |
| Substrate | Access Substrate | Lumi-Phos PRO substrate |
| Reagent Configurations | One Configuration:<br>100 determinations, 2 packs, 50<br>tests/pack | Two Configurations:<br>1) 100 determinations, 2 packs, 50<br>tests/pack (for predicate and<br>candidate instrument)<br>2) 200 determinations, 2 packs,<br>100 tests/pack (for candidate<br>instrument only) |

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# 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<br>Range*<br>(ng/mL) | Slope | Slope<br>95% Cl | Intercept | Intercept<br>95% Cl | R |
|-----|------------------------------------|-------|-----------------|-----------|---------------------|------|
| 150 | 7.0 - 120 | 1.05 | 0.99 –<br>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<br>(Within-Run) | | Between-Run | | Between-Day | | Within-<br>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 |

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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.