ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material

K143376 · Siemens Healthcare Diagnostics, Inc. · JJX · Dec 23, 2014 · Clinical Chemistry

Device Facts

• Record ID: K143376
• Device Name: ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Dec 23, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The ADVIA Centaur® Progesterone (PRGE) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Progesterone assay. The ADVIA Centaur® Ferritin (FER) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Ferritin assay.

Device Story

ADVIA Centaur Master Curve Materials (MCM) are quality control products used to verify calibration and reportable range of ADVIA Centaur Progesterone and Ferritin assays. Progesterone MCM consists of nine levels of progesterone spiked in lyophilized human plasma with sodium azide; Ferritin MCM consists of eight levels of ferritin in human serum with sodium azide. Used in clinical laboratories on ADVIA Centaur systems; operated by laboratory technicians. Healthcare providers use output to perform bi-annual calibration verification checks required for hospital accreditation. Device ensures assay linearity and accuracy, supporting reliable clinical decision-making for progesterone and ferritin testing.

Clinical Evidence

Bench testing only. No clinical studies performed. Stability studies (real-time shelf-life and on-board) and value assignment procedures were conducted to verify performance against pre-defined acceptance criteria.

Technological Characteristics

Progesterone MCM: Lyophilized human plasma, sodium azide (0.1%), 9 levels. Ferritin MCM: Liquid human serum, sodium azide, 8 levels. Both are standalone quality control materials for use on ADVIA Centaur systems. Value assignment is traceable to GC-MS (Progesterone) or WHO 2nd International Standard 80/578 (Ferritin).

Indications for Use

Indicated for in vitro diagnostic use to verify calibration and reportable range of ADVIA Centaur Progesterone and Ferritin assays on ADVIA Centaur systems. Prescription use only.

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)

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

510(k) #: k143376

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.