CalSet IGF-1

K170938 · Roche Diagnostics · JIT · Apr 26, 2017 · Clinical Chemistry

Device Facts

• Record ID: K170938
• Device Name: CalSet IGF-1
• Applicant: Roche Diagnostics
• Product Code: JIT · Clinical Chemistry
• Decision Date: Apr 26, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

CalSet IGF-1 is used for calibrating the quantitative Elecsys IGF-1 assay on the Elecsys and cobas e immunoassay analyzers.

Device Story

CalSet IGF-1 is a two-level lyophilized human serum matrix calibrator used to calibrate quantitative Elecsys IGF-1 assays on Elecsys and cobas e immunoassay analyzers. The device consists of two concentration levels (approx. 20 ng/mL and 500 ng/mL) traceable to WHO IS 02/254. It is used in clinical laboratory settings by trained laboratory personnel. The calibrator is reconstituted with distilled or deionized water before use. By establishing a calibration curve on the analyzer, it enables accurate quantification of IGF-1 in patient samples, supporting clinical assessment of growth hormone-related disorders. The device ensures analytical accuracy and consistency of the immunoassay results.

Clinical Evidence

Bench testing only. Stability studies (real-time, accelerated, and in-use) confirmed the stability of the lyophilized product and reconstituted calibrator under various storage conditions (-20°C, 2-8°C, and on-board). Traceability was established via the WHO IS 02/254 reference material. Value assignment was validated across multiple analyzer modules (cobas e 411, MODULAR ANALYTICS E170, cobas e 602) to ensure performance within specified ranges.

Technological Characteristics

Lyophilized human serum matrix; two concentration levels; traceable to WHO IS 02/254. Reconstituted with 1.0 mL distilled/deionized water. Stability: 31 days at -20°C, 72 hours at 2-8°C, 6 hours on-board at 20-25°C. Used on Elecsys and cobas e immunoassay analyzers.

Indications for Use

Indicated for use as a calibrator for the quantitative Elecsys IGF-1 assay on Elecsys and cobas e immunoassay analyzers. No specific patient population is described as this is an in vitro diagnostic calibrator.

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) #: k170938

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.