Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity

K143026 · Aalto Scientific, Ltd. · JJX · Nov 21, 2014 · Clinical Chemistry

Device Facts

• Record ID: K143026
• Device Name: Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Nov 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Linearity FD Unsaturated Iron Binding Capacity is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration verification, and the verification of reportable range for unsaturated iron binding capacity. Linearity FD Unsaturated Iron Binding Capacity is for In Vitro Diagnostic use only.

Device Story

Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity is a freeze-dried, human serum-based quality control material; provided in five levels (A-E). Used by clinical laboratory personnel to verify linearity, calibration, and reportable range of unsaturated iron binding capacity (UIBC) assays. Device does not perform analysis; rather, it serves as a reference material with assigned target values established via testing on a Hitachi P-Modular analyzer. Healthcare providers use the output (measured values compared to target ranges) to validate assay performance and ensure accurate patient sample testing. Benefits include improved confidence in clinical chemistry assay accuracy and reliability.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (accelerated and real-time) established a 24-month shelf life at 2-8°C and 30-day reconstituted stability. Value assignment performed on Hitachi P-Modular analyzer with target ranges calculated as +/-15% of target mean values.

Technological Characteristics

Human serum-based matrix; freeze-dried form; 5 levels per set; 1ml per vial. Storage 2-8°C. Analyte: Unsaturated Iron Binding Capacity. Value assignment via Hitachi P-Modular analyzer. Non-sterile.

Indications for Use

Indicated for use as an assayed quality control material to simulate human patient samples for determining linearity, calibration verification, and reportable range verification for unsaturated iron binding capacity assays in clinical laboratory settings.

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) #: k143026

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.