RANDOX CSF CONTROLS LEVELS 2 AND 3

K132156 · Randox Laboratories, Ltd. · JJY · Oct 23, 2013 · Clinical Chemistry

Device Facts

• Record ID: K132156
• Device Name: RANDOX CSF CONTROLS LEVELS 2 AND 3
• Applicant: Randox Laboratories, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Oct 23, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Randox CSF Controls Levels 2 and Level 3 are intended for in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for Clinical Chemistry systems. This device is intended for prescription use only.

Device Story

Randox CSF Controls Levels 2 and 3 are buffered aqueous solutions containing biological materials, supplied as lyophilized powder. Used in clinical laboratories to monitor the precision of diagnostic methods for CSF analysis on clinical chemistry systems. The controls provide target values and ranges for analytes including chloride, glucose, IgG, lactic acid, sodium, total protein, and electrophoresis protein fractions (albumin, globulins). Laboratory personnel reconstitute the material and run it alongside patient samples; the healthcare provider compares the measured control values against the provided target ranges to verify the accuracy and precision of the testing system. This ensures the reliability of patient CSF test results.

Clinical Evidence

Bench testing only. Stability studies confirmed 14-day open-vial stability (reconstituted at 2-8°C) and 37-month shelf life (real-time testing). Value assignment was performed using electrophoresis for protein fractions and comparative analysis against master lots for other analytes, with precision (CV) and recovery error metrics reported for each analyte.

Technological Characteristics

Buffered aqueous solution with biological materials (human serum-derived proteins, synthetic chemicals). Supplied as lyophilized powder in 3ml vials. Analyte traceability to commercial sources. Stability: 14 days reconstituted at 2-8°C; 37 months shelf life at 2-8°C. No software or electronic components.

Indications for Use

Indicated for in vitro diagnostic use as assayed quality control material to monitor the precision of diagnostic methods using CSF as a sample on clinical chemistry systems. Intended 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) #: k132156

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.