RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL

K140522 · Randox Laboratories Limited · JJY · May 22, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140522
• Device Name: RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL
• Applicant: Randox Laboratories Limited
• Product Code: JJY · Clinical Chemistry
• Decision Date: May 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

This product is intended for in vitro diagnostic use as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert. This in vitro diagnostic device is intended for prescription use only.

Device Story

Randox Immunoassay Premium Plus Controls are lyophilized human serum-based quality control materials used to monitor the performance of clinical chemistry and immunoassay systems. The device is supplied in three levels (Level 1, 2, and 3) and a Tri-Level configuration. It is intended for use by laboratory professionals in clinical settings to verify the accuracy and reproducibility of 49 specific analytes (e.g., hormones, therapeutic drugs, tumor markers, vitamins). The user reconstitutes the lyophilized serum with distilled water and processes it alongside patient samples on diagnostic analyzers. The resulting output—measured analyte concentrations—is compared against assigned values provided by the manufacturer to assess system performance. By identifying potential deviations in instrument, reagent, or technique, the device helps ensure the reliability of patient test results.

Clinical Evidence

Bench testing only. Stability studies (open-vial and frozen) confirmed that analytes remain within ≤10% deviation from fresh samples when stored according to instructions. Accelerated and real-time stability testing supported a 3-year shelf life. Value assignment was performed via consensus of external laboratories and in-house testing using statistical analysis (mean, SD, %CV).

Technological Characteristics

Lyophilized human serum matrix; requires reconstitution with distilled water. Analyte-specific quality control material. Storage: 2-8°C (unopened). Stability: 7 days at 2-8°C (reconstituted) for most analytes; specific analytes (C-Peptide, PTH, Thyroglobulin, ACTH) have shorter stability windows. No electronic components, software, or energy sources.

Indications for Use

Indicated for in vitro diagnostic use as assayed quality control material to monitor accuracy and reproducibility of specific analytes in clinical chemistry and immunoassay systems. 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)

{0}

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k140522

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.