Lumipulse G FSH-N Calibrators

K163534 · Fujirebio Diagnostics,Inc. · JIT · Jan 13, 2017 · Clinical Chemistry

Device Facts

• Record ID: K163534
• Device Name: Lumipulse G FSH-N Calibrators
• Applicant: Fujirebio Diagnostics,Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jan 13, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

Lumipulse G FSH-N Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G FSH-N on the LUMIPULSE G System.

Device Story

Lumipulse G FSH-N Calibrators are liquid, ready-to-use reagents used to calibrate the Lumipulse G FSH-N assay on the LUMIPULSE G System. The calibrator kit consists of two levels (0 mIU/mL and 250 mIU/mL) containing follicle-stimulating hormone (FSH) in a Tris buffer with bovine protein stabilizer and sodium azide preservative. The device is used in clinical laboratory settings by trained laboratory personnel. Master calibration data are encoded in a 2D barcode on the immunoreaction cartridge case. The system uses this data and the calibrator measurements to generate a calibration curve, which is then used to automatically calculate the FSH concentration of patient specimens in mIU/mL. This quantitative output assists clinicians in assessing patient FSH levels, which is relevant for reproductive health and endocrine function diagnostics.

Clinical Evidence

Bench testing only. No clinical data. Performance was validated through analytical studies including stability (real-time and open-vial), transport simulation, and value assignment traceability to the 1st International Standard (NIBSC 92/510). Stability studies confirmed a 12-month shelf life at 2-10°C. Accuracy and reproducibility met pre-defined acceptance criteria (e.g., CV ≤10%, accuracy within ±20%).

Technological Characteristics

Liquid, ready-to-use calibrator set. Contains FSH antigen in 0.15 M sodium chloride, Tris buffer, bovine protein stabilizer, and sodium azide preservative. Traceable to NIBSC 92/510. Designed for use with the LUMIPULSE G System. Stability validated per CLSI EP25-A. Storage at 2-10°C.

Indications for Use

Indicated for in vitro diagnostic use in the calibration of the Lumipulse G FSH-N assay on the LUMIPULSE G System. No specific patient population is described.

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) #: k163534

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.