Elecsys Progesterone III CalSet

K152526 · Roche Diagnostics · JIT · Oct 2, 2015 · Clinical Chemistry

Device Facts

• Record ID: K152526
• Device Name: Elecsys Progesterone III CalSet
• Applicant: Roche Diagnostics
• Product Code: JIT · Clinical Chemistry
• Decision Date: Oct 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Progesterone III CalSet is used for calibrating the quantitative Elecsys Progesterone III assay on the Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys Progesterone III CalSet is a lyophilized, plant-derived progesterone product in a human serum matrix. It serves as a secondary calibrator for the Elecsys Progesterone III assay on Elecsys and cobas e immunoassay analyzers. The device is used in clinical laboratory settings by trained laboratory personnel. The calibrator is reconstituted with distilled or deionized water and used to establish the calibration curve for the immunoassay. By providing known target values, it enables the analyzer to quantify progesterone levels in patient samples, assisting clinicians in diagnostic decision-making related to progesterone levels. The primary change from the predicate is the addition of stability claims at -20°C.

Clinical Evidence

Bench testing only. No clinical data. Stability studies included reconstitution testing, accelerated stability (35°C for 3 weeks), and ongoing real-time stability (up to 19 months). Value assignment was validated across multiple cobas e 411 and cobas e 601/MODULAR ANALYTICS E170 analyzers. Acceptance criteria for recovery were 95-105% of reference values.

Technological Characteristics

Lyophilized plant-derived progesterone in human serum matrix. Traceable via ID-GC/MS to BCR-348R and ERM-DA347. Two-level calibrator. Requires reconstitution with 1.0 mL distilled/deionized water. Stability: 2-8°C (unopened until expiration), 24 hours (opened at 2-8°C), 31 days (opened at -20°C).

Indications for Use

Indicated for use as a calibrator for the quantitative Elecsys Progesterone III 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) #: k152526

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.