LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK

K130963 · Bio-Rad Laboratories, Inc. · JJY · May 6, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130963
• Device Name: LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: May 6, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

Liquichek Pediatric 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

Liquichek Pediatric Control is a bovine serum-based quality control material containing added chemicals, therapeutic drugs, preservatives, and stabilizers. It is used in clinical laboratories to monitor the precision of testing procedures for analytes including bilirubin (direct/total), caffeine, calcium, chloride, glucose, magnesium, potassium, sodium, and theophylline. The control is provided in liquid form. Laboratory personnel use the product to verify the performance of testing instrumentation and reagents by comparing results against provided mean values and ±3SD ranges. It serves as a guide for laboratories to establish their own acceptable performance ranges, helping ensure the accuracy and reliability of patient test results.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time and accelerated) were conducted to establish shelf-life, thawed unopened stability (45 days at 2-8°C), and thawed opened stability (14 days at 2-8°C).

Technological Characteristics

Bovine serum matrix with added chemicals, therapeutic drugs, preservatives, and stabilizers. Liquid form. Storage at -20 to -50°C. Analyte list includes bilirubin, caffeine, calcium, chloride, glucose, magnesium, potassium, sodium, and theophylline.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for specific analytes in a clinical laboratory setting.

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) #: k130963

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.