LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL

K133960 · Bio-Rad Laboratories · JJY · Jan 22, 2014 · Clinical Chemistry

Device Facts

• Record ID: K133960
• Device Name: LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Lyphochek Specialty Immunoassay Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Device Story

Lyphochek Specialty Immunoassay Control is a human serum-based, lyophilized quality control material containing stabilizers and preservatives. It is designed for use in clinical laboratories to monitor the precision of immunoassay testing procedures for specific analytes: Erythropoietin (EPO), Procalcitonin, Intact Parathyroid Hormone (Intact PTH), Sex Hormone Binding Globulin (SHBG), and Vitamin D. The device is provided in multiple levels to allow for multi-point monitoring of assay performance. Laboratory personnel reconstitute the lyophilized material and process it alongside patient samples using standard laboratory instrumentation and reagents. The resulting values are compared against the provided mean and ±3SD ranges to assess the stability and accuracy of the testing system over time. By identifying potential variations in laboratory technique, instrumentation, or reagent performance, the control helps ensure the reliability of clinical diagnostic results, ultimately supporting accurate patient diagnosis and management.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time and accelerated) were conducted to establish shelf life (36 months at 2-8°C), reconstituted vial stability, and frozen aliquot stability. Mean values and ±3SD ranges were derived from replicate analyses using manufacturer-supported reagents.

Technological Characteristics

Human serum-based control; lyophilized form; contains stabilizers and preservatives. Analyte list: EPO, Procalcitonin, Intact PTH, SHBG, Vitamin D. Storage: 2-8°C. Reconstituted stability varies by analyte (3-30 days).

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for specific analytes (Erythropoietin, Procalcitonin, Intact PTH, SHBG, Vitamin D) 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 SUMMARY

510(k) #: k133960

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.