Access Free T4

K240273 · Beckman Coulter, Inc. · CEC · Mar 6, 2024 · Clinical Chemistry

Device Facts

• Record ID: K240273
• Device Name: Access Free T4
• Applicant: Beckman Coulter, Inc.
• Product Code: CEC · Clinical Chemistry
• Decision Date: Mar 6, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1695
• Device Class: Class 2

Indications for Use

The Access Free T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free thyroxine levels in human serum and plasma (heparin) for the diagnosis and treatment of thyroid diseases using the Access Immunoassay Systems.

Device Story

Access Free T4 is a two-step, competitive enzyme immunoassay used in clinical laboratories to measure free thyroxine (T4) levels. The device utilizes paramagnetic particles coated with streptavidin and biotinylated mouse monoclonal anti-T4 antibodies. Input samples (human serum or heparin plasma) are processed on Access Immunoassay Systems (Access 2 or Dxl 9000). The assay employs a chemiluminescent detection principle. The system automates the reaction, washing, and signal measurement. Healthcare providers use the quantitative output to assess thyroid function, supporting clinical diagnosis and treatment monitoring. The device provides high-throughput, automated analysis, reducing manual labor and improving consistency in thyroid hormone testing.

Clinical Evidence

Bench testing only. Method comparison studies (N=163) using Passing-Bablok regression showed slopes of 1.02 (95% CI: 1.00-1.04) for Access 2 and 1.02 (95% CI: 0.99-1.05) for Dxl 9000 compared to the predicate. Imprecision studies (CLSI EP05-A3) demonstrated within-laboratory %CV ≤ 10.0% for values ≥ 0.61 ng/dL. Detection limits (LoB/LoD/LoQ) were established per CLSI EP17-A2. Interference testing confirmed no significant bias (± 10%) for common substances, including biotin up to 3,510 ng/mL.

Technological Characteristics

Two-step competitive chemiluminescent immunoassay. Reagents include paramagnetic particles coated with streptavidin and biotinylated mouse monoclonal anti-T4 antibodies. Analyzers: Access 2 and Dxl 9000. Measuring range: 0.32–6.0 ng/dL (Dxl 9000) or 0.40–6.0 ng/dL (Access 2). Sample volume: 30 μL. Reagent stability: 28 days at 2-10°C. Automated processing.

Indications for Use

Indicated for the quantitative determination of free thyroxine (T4) levels in human serum and plasma (heparin) to aid in the diagnosis and treatment of thyroid diseases.

Regulatory Classification

Identification

A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Submission Summary (Full Text)

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

510(k) Number: K240273

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