CalSet IGF-1
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.
Related Devices
- K103221 — ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 · Roche Diagnostics · Dec 23, 2010
- K122141 — IDS-ISYS IGF-I CALIBRATION VERIFIERS · Immunodiagnostic Systems , Ltd. · Aug 7, 2012
