ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3

K131776 · Randox Laboratories, Ltd. · JJX · Jul 18, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131776
• Device Name: ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3
• Applicant: Randox Laboratories, Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jul 18, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Randox Aldolase Control Level 2 and Aldolase Control Level 3 are intended for in vitro diagnostic use as assayed quality control materials for the quantitative determination of aldolase on the clinical chemistry analyzers indicated in the package insert. This device is for prescription use only.

Device Story

Randox Aldolase Control Level 2 and Level 3 are lyophilized quality control materials derived from human serum with added human-origin constituents, chemicals, stabilizers, and preservatives. Used in clinical laboratories to monitor the precision of aldolase testing procedures on clinical chemistry analyzers. Requires reconstitution with distilled water before use. Stability is 5 days refrigerated after reconstitution. Healthcare providers use the control results to verify the accuracy and precision of patient sample testing. Benefits include ensuring reliable diagnostic performance of aldolase assays.

Clinical Evidence

Bench testing only. Stability studies confirmed 24-month shelf life for unopened vials and 5-day stability for reconstituted vials stored at 2-8°C. Value assignment performed via nest testing across multiple systems (RX Daytona, Beckman Coulter AU640) with precision (CV%) meeting acceptance criteria of ≤3% (or ≤6% for concentrations <10 IU/L).

Technological Characteristics

Lyophilized human serum matrix; requires reconstitution with distilled water. Analyte: Aldolase (rabbit muscle origin). Storage: 2-8°C. Shelf life: 24 months. Open-vial stability: 5 days at 2-8°C. Used as a quality control material for clinical chemistry analyzers.

Indications for Use

Indicated for use as assayed quality control materials for the quantitative determination of aldolase on clinical chemistry analyzers. For 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 SUMMARY

510(k) #: k131776

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.