LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK

K052053 · Bio-Rad · DIF · Aug 9, 2005 · Clinical Toxicology

Device Facts

• Record ID: K052053
• Device Name: LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK
• Applicant: Bio-Rad
• Product Code: DIF · Clinical Toxicology
• Decision Date: Aug 9, 2005
• 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 laboratory settings by laboratory personnel to monitor the performance of qualitative urine toxicology testing procedures. The control provides a known sample to verify assay accuracy and precision. It is stored at 2-8°C and remains stable for 30 days once opened. By ensuring the reliability of toxicology screening, the device assists healthcare providers in accurately identifying drug presence, thereby supporting clinical decision-making regarding patient treatment and management.

Clinical Evidence

No clinical data. Bench testing only. Stability was validated through accelerated stability studies (3-year shelf life prediction using 20-kCal/mole activation energy) and open-vial stability testing (30 days). Value assignment was performed using HPLC, LC/MS/MS, and GCMS at three reference laboratories.

Technological Characteristics

Liquid matrix derived from human urine; contains drugs of abuse, metabolites, preservatives, and stabilizers. Storage: 2-8°C. Open-vial stability: 30 days at 2-8°C or 18-25°C. Shelf life: 3 years at 2-8°C.

Indications for Use

Indicated for use as an assayed quality control urine to monitor the performance of laboratory procedures for qualitative urine toxicology. Intended for prescription use.

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 (k033366)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k052053

B. Purpose for Submission:
New device

C. Measurand:
Urine Toxicology Control Material (Drug Mixture) for the following analytes: Amphetamines (d-Amphetamine, d-Methamphetamine and MDMA), Barbiturates (Secobarbital), Benzodiazepines (Nordiazepam and Oxazepam), Cannabinoids (11-Nor-Δ-9-THC-9-COOH), Cocaine (Benzoylecgonine), Ethanol, LSD, Methadone, Methaqualone, Opiates (Morphine, free), Oxycodone, Phencyclidine, Propoxyphene and TCA (Nortriptyline).

D. Type of Test:
Control Material

E. Applicant:
Bio-Rad Laboratories

F. Proprietary and Established Names:
Liquicheck Urine Toxicology Control

G. Regulatory Information:
1. Regulation section:
21 CFR§862.3280
2. Classification:
Class I, reserved

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3. Product code:
DIF

4. Panel:
91

H. Intended Use:

1. Intended use(s):
See indications for use

2. Indication(s) 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.

3. Special conditions for use statement(s):
For prescription use

4. Special instrument requirements:
Not applicable

I. Device Description:

Liquichek 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. The control is provided in liquid form. The control contains Amphetamines (d-Amphetamine, d-Methamphetamine and MDMA), Barbiturates (Secobarbital), Benzodiazepines (Nordiazepam and Oxazepam), Cannabinoids (11-Nor-Δ-9-THC-9-COOH), Cocaine (Benzoylecgonine), Ethanol, LSD, Methadone, Methaqualone, Opiates (Morphine, free), Oxycodone, Phencyclidine, Propoxyphene and TCA (Nortriptyline).

J. Substantial Equivalence Information:

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

2. Predicate 510(k) number(s):

2

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k033366

## 3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended 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. | 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. |
| Form | Liquid | Liquid |
| Matrix | Urine | Urine |
| Storage (unopened) | 2-8°C until expiration date | 2-8°C until expiration date |
| Open Vial | 30 days at 2-8°C or 18-25°C | 30 days at 2-8°C or 18-25°C |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analytes | Amphetamines (d-Amphetamine, d-Methamphetamine and MDMA), Barbiturates (Secobarbital), Benzodiazepines (Nordiazepam and Oxazepam), Cannabinoids (11-Nor-Δ-9-THC-9-COOH), Cocaine (Benzoylecgonine), Ethanol, LSD, Methadone, Methaqualone, Opiates (Morphine, free), Oxycodone, Phencyclidine, Propoxyphene and TCA ( Nortriptyline). | Amphetamines (d-Amphetamine, d-Methamphetamine and MDMA), Barbiturates (Secobarbital), Benzodiazepines (Nordiazepam and Oxazepam), Cannabinoids (11-Nor-Δ-9-THC-9-COOH), Cocaine (Benzoylecgonine), Ethanol, LSD, Methadone, Methaqualone, Opiates (Morphine, free), Phencyclidine, Propoxyphene and TCA ( Nortriptyline).
Does not contain Oxycodone |

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

None Referenced

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L. Test Principle:

Not applicable. This submission is for clearance of control material.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable.

b. Linearity/assay reportable range:

Not applicable.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Value assignment is based on multiple days and duplicate 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 performance.

Open vial stability 2-8 °C was tested at 6 time points (0, 8, 14, 22, 30 and 39 days), the last of which (Tfinal) extends to 20% longer than the expiration date of the control. The acceptance criterion was defined as positive reactions for Positive control and negative reactions for Negative control at both Tzero and TFinal test points.

Closed stability was determined using an accelerated stability study and the product was predicated to have a 3 year shelf life when stored at 2-8°C. The product was tested at three elevated temperatures and the shelf stability was predicated using a stability model with activation energy of 20-kCal/mole. Acceptance criterion was defined as positive reactions for Positive control and negative reactions for Negative control at accelerated period of time equivalent to ≥ 3 years at normal storage conditions.

Real-time stability studies are ongoing. The test vials have been stored at 2-8°C and at -20°C (pseudo Tzero) and will be tested at several time points. The qualitative results for each time point will be compared against Tzero values. Failure is assumed to have taken place when the analyte qualitative results do not indicate a positive reaction for Positive control and negative reaction for negative control.

d. Detection limit:

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Not applicable

e. Analytical specificity:
Not applicable

f. Assay cut-off:
Not applicable

2. Comparison studies:
a. Method comparison with predicate device:
Not applicable
b. Matrix comparison:
Not applicable

3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Not applicable

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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O. Conclusion:

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

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