ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR

K122599 · Siemens Healthcare Diagnostics, Inc. · DDR · Oct 3, 2012 · Immunology

Device Facts

• Record ID: K122599
• Device Name: ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: DDR · Immunology
• Decision Date: Oct 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5680
• Device Class: Class 2

Indications for Use

The ADVIA® Chemistry Myoglobin assay is for in vitro diagnostic use in the quantitative measurement of myoglobin in human serum or plasma on the ADVIA® Chemistry systems. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease. The ADVIA Chemistry Myoglobin calibrator is for in vitro diagnostic use in the calibration of ADVIA® Chemistry system for Myoqlobin assay.

Device Story

ADVIA 1650 Chemistry Myoglobin assay is an in vitro diagnostic reagent kit for quantitative myoglobin measurement in human serum or plasma. The device uses latex-particle-enhanced immunoturbidimetric technology; samples are diluted and mixed with R1 buffer and R2 reagent (antibody-coated latex particles). Antibody-antigen complex formation increases turbidity, measured at 571 nm. Myoglobin concentration is determined via a standard curve constructed from calibrators. The system is intended for clinical laboratory use by trained personnel. Results aid clinicians in the rapid diagnosis of heart or renal disease. The assay is provided as ready-to-use liquid reagents; calibrators are human-serum-based, lyophilized, and require reconstitution. The device provides automated, high-throughput analysis on the ADVIA Chemistry system, facilitating rapid diagnostic decision-making.

Clinical Evidence

Bench testing only. Performance evaluated via precision (CLSI EP05-A2), linearity, LoB/LoD/LoQ (CLSI EP17-A), and interference studies. Method comparison with predicate (ADVIA Centaur) using 71 serum and 64 plasma samples showed correlation coefficients of 0.99 for both. No clinical studies or clinical cut-off data were required.

Technological Characteristics

Latex-particle-enhanced immunoturbidimetric assay. Reagents: R1 (buffer) and R2 (antibody-coated latex particles). Measurement wavelength: 571 nm. Calibrators: Lyophilized human serum-based, 4 levels (50-720 ng/mL). Analytical range: 22-680 ng/mL. Instrument: ADVIA Chemistry systems. Standards: CLSI EP07-A2 (interference), EP17-A (LoD/LoQ), EP05-A2 (precision).

Indications for Use

Indicated for the quantitative measurement of myoglobin in human serum or plasma to aid in the diagnosis of heart or renal disease. No specific age or gender restrictions provided.

Regulatory Classification

Identification

A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

Submission Summary (Full Text)

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Statement for the Record, k122599

This 510(k) was reviewed under OIVD’s Pilot Triage 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.