Elecsys Progesterone III Cal Check 5

K150955 · Roche Diagnostics · JJX · May 1, 2015 · Clinical Chemistry

Device Facts

• Record ID: K150955
• Device Name: Elecsys Progesterone III Cal Check 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: May 1, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Elecsys Progesterone III CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Progesterone III reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys Progesterone III CalCheck 5 is a lyophilized, multi-level assayed control consisting of plant-derived progesterone in a human serum matrix. It is used in clinical laboratories to verify calibration and assay range for the Elecsys Progesterone III reagent on Roche Elecsys and cobas e immunoassay analyzers. The device is reconstituted with distilled or deionized water by laboratory personnel. The healthcare provider uses the recovered values of the CalCheck to ensure the immunoassay analyzer is performing within established specifications. This verification process helps maintain the accuracy and reliability of patient progesterone test results, supporting clinical decision-making in endocrine testing.

Clinical Evidence

Bench testing only. Stability studies (open-vial and accelerated) were conducted on the cobas e 411 analyzer. Open-vial stability confirmed 4-hour stability at 20-25°C. Accelerated stability (35°C for 3 weeks) supported an 18-month shelf-life at 2-8°C. Value assignment was performed in duplicate on at least three cobas e 601 analyzers, with acceptance criteria met for mean recovery.

Technological Characteristics

Lyophilized human serum matrix containing plant-derived progesterone. Traceable to ID-GC/MS (isotope dilution gas chromatography mass spectrometry) analogous to BCR-348R and ERM-DA347. Five levels provided. Reconstitution required with 1.0 mL distilled/deionized water. Compatible with MODULAR ANALYTICS E170, cobas e 411, cobas e 601, and cobas e 602 analyzers.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys Progesterone III reagent on Elecsys and cobas e immunoassay analyzers. No specific patient population is described as this is a laboratory control product.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

{0}

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k150955

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.