LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455

K033366 · Bio-Rad · DIF · Dec 12, 2003 · Clinical Toxicology

Device Facts

• Record ID: K033366
• Device Name: LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455
• Applicant: Bio-Rad
• Product Code: DIF · Clinical Toxicology
• Decision Date: Dec 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Indications for Use

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

Device Story

Liquichek Qualitative Urine Toxicology Control is a liquid-form quality control material derived from human urine; supplemented with drugs of abuse, metabolites, preservatives, and stabilizers. Used in clinical laboratories to monitor performance of qualitative urine toxicology testing procedures. The control provides a known reference to verify assay accuracy and precision. Healthcare providers use the output to validate that laboratory testing systems are functioning correctly before reporting patient results. Benefits include ensuring reliability of toxicology screening results, thereby supporting accurate clinical decision-making regarding patient drug status.

Clinical Evidence

No clinical data. Stability testing was performed to validate shelf life (3 years at 2-8°C) and open-vial stability (30 days at 2-8°C or 18-25°C).

Technological Characteristics

Liquid-form human urine matrix; contains drugs of abuse, metabolites, preservatives, stabilizers, and animal-origin constituents. Value assignment via HPLC, LC/MS/MS, and GCMS.

Indications for Use

Indicated for use as an assayed quality control urine to monitor laboratory performance for qualitative urine toxicology testing.

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 Qualitative Urine Toxicology Control (K001973)

Submission Summary (Full Text)

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

A. 510(k) Number:
K033366

B. Analyte:
Urine Toxicology Control Material (Drug Mixture)

C. Type of Test:
Control Material

D. Applicant:
Bio-Rad Laboratories

E. Proprietary and Established Names:
Liquicheck Urine Toxicology Control

F. Regulatory Information:
1. Regulation section:
21CFR862.3280
2. Classification:
Class I
3. Product Code:
DIF
4. Panel:
91

G. Intended Use:
1. Intended use(s):
2. Indication(s) for use:
Liquicheck Qualitative Urine Toxicology Control is intended for use as an assayed quality control urine to monitor the performance of laboratory procedures for qualitative urine toxicology.
3. Special condition for use statement(s):
4. Special instrument Requirements:

H. Device Description:
Liquicheck Qualitative Urine Toxicology Controls are prepared from human urine with added drugs of abuse and metabolites of drugs of abuse, preservatives, stabilizers and constituents of animal origin. They are in liquid form. They contain 11-Nor-Δ-THC-9-COOH, amphetamines (d-amphetamine, d-

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methamphetamine and MDMA), secobarbital, nordiazepam, oxazepam, cannabinoids, cocaine, ethanol, LSD, methadone, methaqualone, morphine, phencyclidine, propoxyphene and nortriptyline.

## I. Substantial Equivalence Information:

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

2. Predicate K number(s):
K001973

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

## J. Standard/Guidance Document Referenced (if applicable):

## K. Test Principle:

N/A. This 510(k) describes control material only.

## L. 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 of triplicate analyses of control solutions at 3 reference laboratories, using HPLC for nortriptyline, LC/MS/MS for LSD and GCMS for all other drugs. The manufacturer recommends that laboratories using Liquicheck controls should use these results only as a reference and establish its own parameters for precision.

Open vial stability at 2-8 °C is tested at 6 time points, the last of which (t_final) extends to 20% longer than the expiration date. Recovery of the sample tested at that time point is compared, by GCMS, to a freshly opened vial. Acceptance criteria are that t_final must be within +/- 10% of the T_zero value.

Real-time stability studies 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 2-8 or -20 °C.

d. Detection limit:
N/A

e. Analytical specificity:

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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):

4. Clinical cut-off:
N/A

5. Expected values/Reference range:
N/A

M. Conclusion:
I recommend that the Biorad Liquichek Toxicology Controls are substantially equivalent to the predicate device.