Lumipulse G Prolactin

K163544 · Fujirebio Diagnostics,Inc. · JIT · Jan 12, 2017 · Clinical Chemistry

Device Facts

• Record ID: K163544
• Device Name: Lumipulse G Prolactin
• Applicant: Fujirebio Diagnostics,Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jan 12, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

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

Device Story

Lumipulse G Prolactin Calibrators are liquid, ready-to-use reagents used to calibrate the Lumipulse G Prolactin assay on the LUMIPULSE G System. The kit consists of two levels: 0 ng/mL and 400 ng/mL. The calibrators are prepared gravimetrically using prolactin antigen in a Tris buffer with protein stabilizer and sodium azide preservative. They are used by laboratory professionals in a clinical setting to establish the calibration curve for the automated immunoassay analyzer. By ensuring accurate calibration, the device enables the analyzer to provide reliable quantitative prolactin measurements, which assist clinicians in diagnosing and monitoring conditions related to prolactin levels.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was validated through analytical studies including real-time and accelerated stability testing, transport simulation, and value assignment verification. Stability studies confirmed a 12-month shelf life at 2-10°C.

Technological Characteristics

Liquid, ready-to-use calibrator kit. Contains prolactin in 0.15 M sodium chloride, Tris buffer, bovine protein stabilizer, and sodium azide preservative. Traceable to 3rd International Standard 84/500. Designed for use on the LUMIPULSE G System. Standards referenced: ISO 17511:2003, CLSI EP25-A.

Indications for Use

Indicated for in vitro diagnostic use in the calibration of the Lumipulse G Prolactin assay on the LUMIPULSE G System. No specific patient population or contraindications 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) #: k163544

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.