MAGLUMI 2000 FT4

K182423 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · CEC · Oct 4, 2018 · Clinical Chemistry

Device Facts

• Record ID: K182423
• Device Name: MAGLUMI 2000 FT4
• Applicant: Shenzhen New Industries Biomedical Engineering Co., Ltd.
• Product Code: CEC · Clinical Chemistry
• Decision Date: Oct 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1695
• Device Class: Class 2

Indications for Use

The MAGLUMI 2000 FT4 assay is for in vitro diagnostic use in the quantitative determination of free thyroxine (FT4) in human serum. The measurement of FT4 is used in the diagnosis of thyroid disorders.

Device Story

MAGLUMI 2000 FT4 is an in vitro diagnostic assay for quantitative measurement of free thyroxine (FT4) in human serum. It utilizes a competitive chemiluminescence immunoassay principle on the MAGLUMI 2000 instrument. The assay involves mixing patient serum with ABEI-labeled anti-T4 monoclonal antibody, buffer, and T4 antigen-coated magnetic microbeads. Free T4 in the sample competes with immobilized T4 for binding sites on the labeled antibody. After incubation at 37°C, magnetic separation, and washing, starter reagents are added to trigger a chemiluminescent reaction. A photomultiplier measures the light signal (RLUs), which is inversely proportional to the FT4 concentration. The device is intended for use in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing thyroid disorders. The system provides automated processing and analysis, offering a diagnostic tool for thyroid function assessment.

Clinical Evidence

Bench testing only. Performance validated per CLSI guidelines (EP5-A2, EP6-A, EP17-A2, EP7-A2, EP9-A2). Precision studies (N=240 per level) showed total CVs ranging from 3.20% to 9.99%. Linearity confirmed between 0.19 and 10.0 ng/dL (R2=0.9991). Method comparison with predicate (N=224) yielded Y = 1.0451X - 0.05375 (R2=0.9919). Interference testing confirmed no significant impact from common drugs, bilirubin, hemoglobin, triglycerides, HAMA, RF, or total protein. Reference range established using 157 healthy adults (0.82–1.72 ng/dL).

Technological Characteristics

Competitive chemiluminescence immunoassay. Reagents: T4 antigen-coated magnetic microbeads, ABEI-labeled anti-T4 monoclonal antibody, buffers, calibrators, and controls. Energy source: Photomultiplier for chemiluminescence detection. Connectivity: Automated system (MAGLUMI 2000). Measuring range: 0.19-10.0 ng/dL. Sample volume: 40 µL. Standards: CLSI EP5-A2, EP6-A, EP17-A2, EP7-A2, EP9-A2, C28-A3.

Indications for Use

Indicated for the quantitative determination of free thyroxine (FT4) in human serum to aid in the diagnosis of thyroid disorders in adults.

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)

{0}

1

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

510(k) Number: k182423

This 510(k) was reviewed under 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.