LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA

K123198 · Bio-Rad Laboratories · JJY · Nov 20, 2012 · Clinical Chemistry

Device Facts

• Record ID: K123198
• Device Name: LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Nov 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Liquichek Ethanol/Ammonia 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 Ethanol/Ammonia Control is an assayed quality control serum used in clinical laboratories to monitor the precision of testing procedures for ethanol and ammonia. The device is prepared from bovine serum albumin with added chemicals, stabilizers, and preservatives. It is provided in a liquid form. Laboratory personnel use the control to verify the performance of their testing instrumentation and reagents by comparing observed results against the provided mean values and ±3SD ranges. This monitoring helps ensure the accuracy and reliability of patient test results, allowing clinicians to make informed diagnostic and treatment decisions based on valid laboratory data.

Clinical Evidence

No clinical data. Bench testing only. Stability studies were performed to validate shelf life (24 months at 2-8°C) and open vial stability (20 days at 2-8°C on Siemens Dimension Vista instrument).

Technological Characteristics

Bovine serum albumin matrix with added chemicals, stabilizers, and preservatives. Liquid form. Storage at 2-8°C. Analyte content: Ethanol and Ammonia. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for ethanol and ammonia. No specific patient population is described as this is an in vitro diagnostic control product.

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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Statement for the Record, k123198

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.