LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK

K123775 · Bio-Rad Laboratories · JJY · Jan 31, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123775
• Device Name: LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 31, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Liquichek Spinal Fluid Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Device Story

Liquichek Spinal Fluid Control is a human-based, liquid, multi-analyte quality control material. It contains human and animal-derived constituents, chemicals, preservatives, and stabilizers. Used in clinical laboratories to monitor the precision of testing procedures for specific analytes in spinal fluid. The control is provided in liquid form for convenience. Healthcare providers use the control to verify the performance of laboratory instrumentation and reagents. By comparing observed results against assigned mean values and ±3SD ranges, laboratories can assess the accuracy and precision of their testing processes, ensuring reliable diagnostic results for patients. The device is manufactured from human donor units tested and found non-reactive for HBsAg, anti-HCV, and anti-HIV-1/HIV-2.

Clinical Evidence

No clinical data. Stability studies were performed to validate shelf life (2 years at 2-8°C) and open vial stability (30 days at 2-8°C). Mean values and ±3SD ranges were derived from replicate analyses using manufacturer-supported reagents.

Technological Characteristics

Liquid control matrix consisting of diluted human serum with added human/animal constituents, chemicals, preservatives, and stabilizers. Storage at 2-8°C. Analyte list: Albumin, Chloride, Glucose, IgG, Lactate, LDH, Total Protein, Sodium. No software or electronic components.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision of laboratory testing procedures for specific analytes (Albumin, Chloride, Glucose, IgG, Lactate, LDH, Total Protein, Sodium) in spinal fluid. For professional laboratory use.

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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# Decision Summary

Statement for the Record, k123775

This 510(k) was reviewed under OIR's Pilot Triage 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.