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

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 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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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) Number: K223503

This 510(k) was reviewed under the OHT7 OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.