Elecsys T-Uptake Calset

K143342 · Roche Diagnostics · JIT · Dec 19, 2014 · Clinical Chemistry

Device Facts

• Record ID: K143342
• Device Name: Elecsys T-Uptake Calset
• Applicant: Roche Diagnostics
• Product Code: JIT · Clinical Chemistry
• Decision Date: Dec 19, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

T-Uptake CalSet is used for calibrating the quantitative Elecsys T-Uptake assay on the Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys T-Uptake CalSet is a lyophilized calibrator kit consisting of a buffer/protein/TBG matrix with added L-thyroxine. It is used in clinical laboratory settings to calibrate Elecsys T-Uptake assays on Roche Elecsys and cobas e immunoassay analyzers. The device is operated by laboratory technicians. The calibrator is reconstituted with distilled or deionized water before use. The analyzer uses the calibrator to establish a reference standard curve, which is then used to determine the T-Uptake (thyroxine-binding index) values of patient samples. Proper calibration ensures the accuracy and reliability of the quantitative assay results, which are used by clinicians to assess thyroid function.

Clinical Evidence

Bench testing only. Studies verified stability (reconstitution, accelerated, and real-time) and reconstitution time. Acceptance criteria for signal recovery (95-105% of reference) were met across all stability conditions, including storage at 2-8°C, -20°C, and freeze/thaw cycles. Value assignment was validated by running calibrators in duplicate on multiple analyzers (Elecsys 2010 and MODULAR ANALYTICS E170) and confirming performance against PreciControl Universal acceptance criteria.

Technological Characteristics

Lyophilized buffer/protein (bovine serum albumin)/TBG matrix with added L-thyroxine. Two-level calibrator set. Standardized against a clinically defined human serum panel (mean TBI 1.0). Reconstituted with 1.0 mL distilled/deionized water. Compatible with Elecsys and cobas e immunoassay analyzers.

Indications for Use

Indicated for the calibration of the quantitative Elecsys T-Uptake assay on Elecsys and cobas e immunoassay analyzers.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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

510(k) #: k143342

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.