LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)

K050682 · Bio-Rad Laboratories, Inc. · DIF · Apr 29, 2005 · Clinical Toxicology

Device Facts

• Record ID: K050682
• Device Name: LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: DIF · Clinical Toxicology
• Decision Date: Apr 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Indications for Use

Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.

Device Story

Liquichek Urine Toxicology Control is a liquid-form quality control material derived from human urine; supplemented with drugs of abuse, metabolites, preservatives, and stabilizers. It serves as a reference to monitor the performance of laboratory urine toxicology confirmatory procedures. The device is used by laboratory personnel in clinical settings. It contains a mixture of analytes including amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, ethanol, LSD, methadone, methaqualone, opiates, phencyclidine, propoxyphene, creatinine, and MDMA/MDA/MDEA. Reference values are established via gravimetric methods and GC analysis. The product is tested for HBsAg, HCV, and HIV-1/HIV-2. It provides laboratories with a standardized sample to verify the accuracy and reliability of their toxicology testing workflows.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (open and closed vial) were performed using GC/MS to verify recovery within +/- 10% of Tzero values. Accelerated stability testing predicted a 4-year shelf life.

Technological Characteristics

Liquid-form human urine matrix containing drugs of abuse, metabolites, preservatives, and stabilizers. Stored at 2-8°C. No software or electronic components.

Indications for Use

Indicated for use as a quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures in clinical laboratory settings.

Regulatory Classification

Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

Predicate Devices

• Liquichek Urine Toxicology Control (K033404)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
k050682

B. Purpose for Submission:
New Device

C. Analyte:
Urine Toxicology Control Material (Drug Mixture) for the following analytes:
Amphetamine, Methamphetamine, Secobarbital, Amobarbital, Butalbital,
Phenobarbital, Phenobarbital, Nordazepam, α-hydroxyalprazolam,
Tetrahydrocannabinol, Benzoylecgonine, Ethanol, LSD, Methadone, Methaqualone,
Morphine-3-β-glucuronide, Codeine, Phencyclidine, Norpropoxyphene, Creatinine,
Methylenedioxymethamphetamine (MDMA), Methylenedioxyamphetamine (MDA)
and Methylenedioxyethylamphetamine (MDEA).

D. Type of Test:
Control Material

E. Applicant:
Bio-Rad Laboratories

F. Proprietary and Established Names:
Liquichek Urine Toxicology Control

G. Regulatory Information:
1. Regulation section:
21 CFR 862.3280 Clinical toxicology control material
2. Classification:
Class I, reserved
3. Product Code:
DIF
4. Panel:
91

H. Intended Use:
1. Intended use(s):
See Indications for Use below.
2. Indication(s) for use:
Liquichek Urine Toxicology Control is intended for use as a quality control
urine to monitor the performance of laboratory urine toxicology confirmatory
procedures.

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3. Special condition for use statement(s):
N/A

4. Special instrument Requirements:
N/A

I. Device Description:
Liquichek Urine Toxicology Control is prepared from human urine with added drugs of abuse and metabolites of drugs of abuse, preservatives, stabilizers and constituents of animal origin. The control is provided in liquid form and at several levels that are shown in the package insert. The control contains Amphetamine, Methamphetamine, Secobarbital, Amobarbital, Butalbital, Phenobarbital, Phenobarbital, Nordazepam, α-hydroxyalprazolam, Tetrahydrocannabinol, Benzoylecgonine, Ethanol, LSD, Methadone, Methaqualone, Morphine-3-β-glucuronide, Codeine, Phencyclidine, Norpropoxyphene, Creatinine, Methylenedioxymethamphetamine (MDMA), Methylenedioxyamphetamine (MDA) and Methylenedioxyethylamphetamine (MDEA). Gravimetric reference values and GC analyses are listed in the package insert.

The serum from each donor contributing urine for this product was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.

J. Substantial Equivalence Information:

1. Predicate device name(s):
LiquiChek Urine Toxicology Control

2. Predicate K number(s):
k033404

3. Comparison with predicate:
This control material is similar in composition to the predicate device, except that the new device contains MDMA, MDA and MDEA in control level 1.

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Device Name | LiquiChek Urine Toxicology Control (Level 1) | LiquiChek Urine Toxicology (Level 1) |
| Intended Use | Intended for use as a quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures. | Intended for use as a quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures. |
| Matrix | Urine | Urine |
| Stability | 30 days once opened | 30 days once opened |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Components | Amphetamine, Methamphetamine, Secobarbital, Amobarbital, Butalbital, Phenobarbital, Phenobarbital, Nordazepam, α-hydroxyalprazolam, Tetrahydrocannabinol, Benzoylecgonine, Ethanol, LSD, Methadone, Methaqualone, Morphine-3-β-glucuronide, Codeine, Phencyclidine, Norpropoxyphene, Creatinine, **Methylenedioxymethamphetamine (MDMA)**, **Methylenedioxyamphetamine (MDA) and Methylenedioxyethylamphetamine (MDEA)**. | Amphetamine, Methamphetamine, Secobarbital, Amobarbital, Butalbital, Phenobarbital, Phenobarbital, Nordazepam, α-hydroxyalprazolam, Tetrahydrocannabinol, Benzoylecgonine, Ethanol, LSD, Methadone, Methaqualone, Morphine-3-β-glucuronide, Codeine, Phencyclidine, Norpropoxyphene, Creatinine |

K. Standard/Guidance Document Referenced (if applicable):
None Referenced

L. Test Principle:
N/A. This 510(k) describes control material only.

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
N/A
b. Linearity/assay reportable range:
N/A
c. Traceability (controls, calibrators, or method):
Value assignment is based on the average from triplicate analysis of control solutions at 3 reference laboratories using Gas Chromatography. Approximate GC and gravimetric values are listed in the package insert. The sponsor recommends that each laboratory using Liquichek controls should use these results only as a reference and should establish its own parameters for precision.

Open vial stability 2-8 °C was tested at 6 time points (1, 8, 14, 22, 29 and 36 days), the last of which (T_final) extends to 20% longer than the expiration date of the control. Recovery of the sample tested at the last time point was compared, by GC/MS, to a freshly opened vial. Acceptance criteria are that T_final must be within +/- 10% of the T_zero value.

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Closed stability was determined using an accelerated stability study and the product was predicted to have a 4 year shelf life when stored at 2-8 °C. The product was tested at three elevated temperatures and the shelf stability was predicted using a stability model with activation energy of 20-kCal/mole. Acceptance criteria are defined as recovery values at each time point that are within +/- 10% of the values determined for vials at the Tzero.

Real time closed vial stability are ongoing. Acceptance criteria are defined as recovery values at each time point that are within +/-10% of the values determined for vials stored at 2-8v °C or -20 °C.

d. Detection limit:
N/A

e. Analytical specificity:
N/A

f. Assay cut-off:
N/A

2. Comparison studies:
a. Method comparison with predicate device:
N/A
b. Matrix comparison:
N/A

3. Clinical studies:
a. Clinical sensitivity:
N/A
b. Clinical specificity:
N/A
c. Other clinical supportive data (when a and b are not applicable):
N/A

4. Clinical cut-off:
N/A

5. Expected values/Reference range:
N/A

N. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.