Access Intrinsic Factor Ab

K240800 · Beckman Coulter, Inc. · LIG · May 3, 2024 · Clinical Chemistry

Device Facts

• Record ID: K240800
• Device Name: Access Intrinsic Factor Ab
• Applicant: Beckman Coulter, Inc.
• Product Code: LIG · Clinical Chemistry
• Decision Date: May 3, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1810
• Device Class: Class 2

Intended Use

The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems. It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia.

Device Story

Access Intrinsic Factor Ab is a competitive binding immunoenzymatic assay; utilizes paramagnetic particles and chemiluminescence for detection. Input: human serum or plasma samples. Process: competitive binding reaction performed on Dxl 9000 Access Immunoassay Analyzer; analyzer automates sample processing, incubation, and signal measurement. Output: intrinsic factor antibody concentration (AU/mL). Used in clinical laboratory settings by trained laboratory personnel. Results interpreted by clinicians to aid in diagnosis of pernicious anemia. Benefits: provides standardized, automated diagnostic testing for pernicious anemia.

Clinical Evidence

Bench testing only. Method comparison study of 128 serum samples between Dxl 9000 and Access 2 systems showed 100% negative agreement and 97.5% positive agreement (total agreement 96.9%). Precision study (CLSI EP05-A3) demonstrated within-laboratory imprecision (total CV) ≤ 4.4% across concentrations ranging from 1.0 to 14.0 AU/mL, meeting the ≤ 10.0% CV design goal.

Technological Characteristics

Paramagnetic particle, chemiluminescent immunoassay. Competitive binding immunoenzymatic assay. Analyte: Intrinsic factor antibody. Sample matrix: serum and plasma. Instrument: Dxl 9000 Access Immunoassay Analyzer. Substrate: Lumi-Phos Pro. Calibration: single-level liquid synthetic matrix (1.0 AU/mL).

Indications for Use

Indicated for the detection of intrinsic factor antibodies in human serum and plasma to aid in the diagnosis of pernicious anemia.

Regulatory Classification

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: K240800

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.