LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L

K121084 · Siemens Healthcare Diagnostics, Inc. · JJX · May 9, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121084
• Device Name: LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: May 9, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

LCTNI CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias in the quantitative determination of cardiac troponin-I (CTNI/TNI) on the Dimension Vista® System and Dimension® EXL™ integrated chemistry system with LOCI® module. LCTNI CON M is an assayed, mid level, intralaboratory quality control for assessment of precision and analytical bias in the quantitative determination of cardiac troponin-I (CTNI/TNI) on the Dimension Vista® System and Dimension® EXL™ integrated chemistry system with LOCI® module. LCTNI CON H is an assayed, high level, intralaboratory quality control for assessment of precision and analytical bias in the quantitative determination of cardiac troponin-I (CTNI/TNI) on the Dimension Vista® System and Dimension® EXL™ integrated chemistry system with LOCI® module.

Device Story

LOCI Cardiac Troponin-I Controls (Low, Medium, High) are liquid, frozen, human serum-based quality control materials containing native human cardiac troponin complex. Used in clinical laboratory settings to monitor the performance of the Dimension Vista and Dimension EXL integrated chemistry systems. The controls are processed by laboratory personnel alongside patient samples to verify the accuracy and precision of the cardiac troponin-I assay. By comparing measured control values against established target ranges, clinicians identify potential analytical bias or precision issues, ensuring the reliability of patient test results used for cardiac assessment.

Clinical Evidence

No clinical data. Bench testing only, including validation of traceability, value assignment, stability, and matrix effects.

Technological Characteristics

Liquid, frozen, human serum-based quality control material. Contains native human cardiac troponin complex. Three levels (low, medium, high). Packaged in 2.2 mL vials. Designed for use with Dimension Vista and Dimension EXL integrated chemistry systems utilizing the LOCI module.

Indications for Use

Indicated for use as an assayed, intralaboratory quality control material to assess precision and analytical bias in the quantitative determination of cardiac troponin-I on Siemens Dimension Vista and Dimension EXL integrated chemistry systems.

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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# Decision Summary

Statement for the Record, k121084

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.