ADVIA CENTAUR FT4, ADVIA CENTAUR T4

K132249 · Siemens Healthcare Diagnostics, Inc. · CEC · Sep 13, 2013 · Clinical Chemistry

Device Facts

• Record ID: K132249
• Device Name: ADVIA CENTAUR FT4, ADVIA CENTAUR T4
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: CEC · Clinical Chemistry
• Decision Date: Sep 13, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1695
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

ADVIA Centaur FT4 For in vitro diagnostic use in the quantitative determination of free thyroxine (FT4) in serum or plasma (heparinized or EDTA), using the ADVIA Centaur and ADVIA Centaur XP systems. Measurements of free thyroxine are used in the diagnosis and treatment of thyroid disease. ADVIA Centaur T4 For in vitro diagnostic use in the quantitative determination of thyroxine (T4) in serum using the ADVIA Centaur and ADVIA Centaur XP systems. Measurements of thyroxine are used in the diagnosis and treatment of thyroid disease.

Device Story

ADVIA Centaur FT4 and T4 are in vitro diagnostic assays for quantitative measurement of free thyroxine and total thyroxine in serum or plasma. Used on ADVIA Centaur and ADVIA Centaur XP systems in clinical laboratory settings. Assays utilize immunoassay technology to measure analyte concentrations; results assist clinicians in diagnosing and managing thyroid disease. This submission updates labeling to include pediatric reference intervals derived from 454 patients. No changes to device design, manufacturing, or analytical performance characteristics were made. Healthcare providers interpret results against established reference intervals to assess thyroid function.

Clinical Evidence

No new clinical or analytical performance testing was required. Pediatric reference intervals were established by analyzing data from 454 patients (72 infants, 190 children, 129 adolescents). Performance characteristics are cross-referenced to original 510(k) submissions (K905532, K080167) and system performance submission (K971418).

Technological Characteristics

Immunoassay-based diagnostic tests for use on ADVIA Centaur and ADVIA Centaur XP automated systems. Analytical measuring range: FT4 (0.1–12 ng/dL), T4 (0.3–30 µg/dL). No changes to materials, sensing principles, or software algorithms.

Indications for Use

Indicated for the quantitative determination of free thyroxine (FT4) and total thyroxine (T4) in serum or plasma to aid in the diagnosis and treatment of thyroid disease in patients, including pediatric populations (infants 01-23 months, children 02-12 years, and adolescents 13-21 years).

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) #: k132249

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.