Elecsys TSH

K190773 · Roche Diagnostics · JLW · Apr 16, 2019 · Clinical Chemistry

Device Facts

• Record ID: K190773
• Device Name: Elecsys TSH
• Applicant: Roche Diagnostics
• Product Code: JLW · Clinical Chemistry
• Decision Date: Apr 16, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Indications for Use

Immunoassay for the in vitro quantitative determination of thyrotropin in human serum and plasma. Measurements of TSH are used in the diagnosis of thyroid and pituitary disorders. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

Device Story

Elecsys TSH is an in vitro diagnostic immunoassay for quantitative thyrotropin measurement in human serum and plasma. It utilizes a sandwich electrochemiluminescence (ECLIA) principle on cobas e immunoassay analyzers. The device uses monoclonal antibodies against human TSH; one biotinylated capture antibody and one ruthenium-labeled detection antibody. To mitigate biotin interference, the assay incorporates an anti-biotin antibody to bind free biotin and utilizes a PEG spacer on the biotinylated capture antibody. The device is operated by laboratory professionals in clinical settings. The analyzer processes samples, performs incubation, and measures light emission to quantify TSH levels. Results assist clinicians in diagnosing thyroid and pituitary disorders. The updated design increases biotin interference resistance up to 1200 ng/mL.

Clinical Evidence

Bench testing only. Performance evaluated on cobas e 801 analyzer. Precision studies (repeatability/intermediate) met acceptance criteria. Linearity confirmed 0.004–102 µIU/mL. LoB/LoD/LoQ established at 0.0025/0.005/0.005 µIU/mL. Interference testing confirmed no biotin interference up to 1200 ng/mL. Method comparison with predicate (n=138) showed high correlation (r=0.999) and Passing-Bablok slope of 0.974.

Technological Characteristics

Sandwich immunoassay; electrochemiluminescence (ECLIA) detection. Reagents: Streptavidin-coated microparticles, biotinylated monoclonal anti-TSH antibody (mouse) with PEG spacer, and ruthenium-labeled monoclonal anti-TSH antibody (mouse/human). Instrument: cobas e immunoassay analyzers. Quantitative measurement range: 0.005-100 µIU/mL. Sample types: serum, Li-heparin, K2-EDTA, K3-EDTA plasma. Calibration: 2-point. Traceability: 2nd IRP WHO Reference Standard 80/558.

Indications for Use

Indicated for in vitro quantitative determination of thyrotropin in human serum and plasma to aid in the diagnosis of thyroid and pituitary disorders.

Regulatory Classification

Identification

A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

Submission Summary (Full Text)

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

510(k) Number: k190773

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.