← Product Code [CDD](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD) · K223289

# Access Vitamin B12 (K223289)

_Beckman Coulter, Inc. · CDD · Dec 23, 2022 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K223289

## Device Facts

- **Applicant:** Beckman Coulter, Inc.
- **Product Code:** [CDD](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD.md)
- **Decision Date:** Dec 23, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1810
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of vitamin B12 levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

## Device Story

Access Vitamin B12 assay is a competitive binding immunoenzymatic assay; utilizes paramagnetic particles coated with goat anti-mouse IgG and mouse monoclonal anti-intrinsic factor; conjugate is intrinsic factor-alkaline phosphatase. Input: human serum or plasma samples. Process: two-step competitive chemiluminescent immunoassay performed on Dxl 9000 Access Immunoassay Analyzer. Output: quantitative vitamin B12 concentration (pg/mL). Used in clinical laboratory settings by trained technicians. Results assist clinicians in diagnosing and managing anemias related to gastrointestinal malabsorption.

## Clinical Evidence

Bench testing only. Method comparison study (N=122) vs. predicate showed R2=0.97, slope 1.00 (95% CI 0.96-1.02). Imprecision study (N=84 per sample) demonstrated within-laboratory CV 2.7-7.7% for concentrations >100 pg/mL. Linearity verified across 68-1,500 pg/mL range. LoB 35 pg/mL, LoD 49 pg/mL, LoQ 49 pg/mL.

## Technological Characteristics

Paramagnetic particle, chemiluminescent immunoassay. Solid phase: paramagnetic particles coated with goat anti-mouse IgG and mouse monoclonal anti-intrinsic factor. Conjugate: intrinsic factor-alkaline phosphatase. Two-step competitive binding principle. Automated analysis on Dxl 9000 system. Liquid ready-to-use reagent format. Standardization: USP Reference Material.

## Regulatory Identification

A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

## Submission Summary (Full Text)

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

510(k) Number: K223289

This 510(k) was reviewed under the OHT7/OHT8 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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K223289](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDD/K223289)

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