Lumipulse G LH Calibrators

K163521 · Fujirebio Diagnostics,Inc. · JIT · Jan 12, 2017 · Clinical Chemistry

Device Facts

• Record ID: K163521
• Device Name: Lumipulse G LH Calibrators
• 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 LH Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G LH on the LUMIPULSE G System.

Device Story

Lumipulse G LH Calibrators are liquid, ready-to-use calibrators containing human luteinizing hormone (LH) in a Tris buffer with bovine protein stabilizer and sodium azide preservative. The kit consists of two levels: 0 mIU/mL and 250 mIU/mL. The device is used in a clinical laboratory setting by trained laboratory personnel to calibrate the Lumipulse G LH assay on the LUMIPULSE G System. Calibration establishes the relationship between the instrument's measured luminescence signal and the known concentration of the analyte, enabling the quantitative determination of LH in human serum and plasma samples. This process ensures the accuracy and reliability of patient test results, which are used by clinicians to assess reproductive health and endocrine function.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time and transport simulation) confirmed shelf-life of 12 months at 2-10°C. Traceability established to WHO 2nd International Standard 80/552.

Technological Characteristics

Liquid calibrator kit; contains human LH, Tris buffer, bovine protein stabilizer, sodium azide. Traceable to WHO 2nd International Standard 80/552. Designed for use on LUMIPULSE G System. Storage 2-10°C. Shelf life 12 months.

Indications for Use

Indicated for in vitro diagnostic use in the calibration of the Lumipulse G LH assay on the LUMIPULSE G System. No specific patient population is described as this is a laboratory calibrator product.

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) #: k163521

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.