LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK

K120504 · Bio-Rad Laboratories, Inc. · DIF · Mar 27, 2012 · Clinical Toxicology

Device Facts

• Record ID: K120504
• Device Name: LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: DIF · Clinical Toxicology
• Decision Date: Mar 27, 2012
• 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 precision of laboratory urine toxicology screening procedures.

Device Story

Liquichek Urine Toxicology Control is a liquid, ready-to-use quality control material derived from human urine; supplemented with preservatives, stabilizers, animal-derived constituents, and specific drugs of abuse/metabolites. Used in clinical laboratories to monitor the precision of toxicology screening procedures. The device provides known concentrations of analytes—including cannabinoids, cocaine, ethanol, LSD, methadone, methaqualone, opiates, oxazepam, phencyclidine, propoxyphene, secobarbital, and d-methamphetamine—to verify assay performance. Healthcare providers use the control results to validate the accuracy and reliability of patient sample testing. The product is stored frozen (-20°C to -70°C) and has established stability claims for open and closed vials.

Clinical Evidence

No clinical data. Stability studies were performed to validate shelf life (2 years at -20°C to -70°C), open vial stability (30 days at 2-8°C), and closed vial thawed stability (45 days at 2-8°C).

Technological Characteristics

Human urine matrix; liquid form; ready-to-use. Contains preservatives (antibiotic cocktail). Analytes: cannabinoids, cocaine, ethanol, LSD, methadone, methaqualone, opiates, oxazepam, phencyclidine, propoxyphene, secobarbital, d-methamphetamine. Storage: -20°C to -70°C (unopened); 2°C to 8°C (open/thawed). Stability: 30 days open vial, 45 days closed vial (thawed), 2 years shelf life.

Indications for Use

Indicated for use as a quality control material in laboratory urine toxicology screening procedures to monitor precision. No specific patient population, age, or gender restrictions apply as it is a laboratory control product.

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 (Screen Series) (K033924)

Submission Summary (Full Text)

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

A. 510(k) Number:
K120504

B. Purpose for Submission:
New Device

C. Analyte:
Quality control materials for Cannabinoids (delta-9-THC), cocaine (benzoylecgonine), ethanol, lysergic acid diethlamide (LSD), methadone, methaqualone, opiates (morphine, free), oxazepam, phencyclidine (PCP), propoxyphene, secobarbital, d-Methamphetamine

D. Type of Test:
Not applicable

E. Applicant:
Bio-Rad Laboratories

F. Proprietary and Established Names:
Liquichek Urine Toxicology Control, Level S1O
Liquichek Urine Toxicology Control, Level S1O, MiniPak

Liquichek Urine Toxicology Control, Level S2O
Liquichek Urine Toxicology Control, Level S2O, MiniPak

Liquichek Urine Toxicology Control, Level S1O Low Opiate
Liquichek Urine Toxicology Control, Level S1O Low Opiate, MiniPak

Liquichek Urine Toxicology Control, Level S2O Low Opiate
Liquichek Urine Toxicology Control, Level S1O Low Opiate, MiniPak

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:
Toxicology (91)

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H. Intended Use:

1. Intended use(s):
Refer to Indications for use.

2. Indication(s) for use:
Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the precision of laboratory urine toxicology screening procedures.

3. Special condition for use statement(s):
None

4. Special instrument Requirements:
Not applicable.

I. Device Description:

The product is prepared from human urine with addition of preservatives, stabilizers, constituents of animal origin, abused drugs and their metabolites. It is a liquid ready to use quality control material.

The serum of each donor, who contributed urine for this product, was tested by FDA accepted methods and found to be 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 (Screen Series)

2. Predicate K number(s):
K033924

3. Comparison with predicate:
Showing in table 1, both devices have same matrix and both are quality control materials that measure similar analytes. These two devices are different in that the candidate device added two novel analytes - oxazepam and d-methamphetamine - and removed three analytes - nordiazepam, nortriptyline (TCA), and d-amphetamine. Since the preservative of the candidate device is a cocktail of antibiotics and it does not contain any hazardous materials, the candidate device does not require the hazard symbol.

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Table 1. Similarities and differences between candidate and predicate device.

| Characteristics | Liquichek Urine Toxicology Control (New Device) | Liquichek Urine Toxicology Control (Screen Series) (Predicate Device, K033924) |
| --- | --- | --- |
| Similarities | | |
| Intended Use | Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the precision of laboratory urine toxicology screening procedures. | Liquichek Urine Toxicology Control (Screen Series) is intended for use as quality control urine to monitor the precision of laboratory urine toxicology screening procedures. |
| Matrix | Human Urine | Human Urine |
| Form | Liquid | Liquid |
| Open vial stability | 30 days at 2 °C to 8 °C | 30 days at 2 °C to 8 °C |
| Differences | | |
| --- | --- | --- |
| Storage unopened (shelf Life) | -20 °C to -70 °C until expiration date | 2 °C to 8 °C until expiration date |
| Closed Vial (Thawed) Stability | 45 days at 2 °C to 8 °C | No Claim |
| Levels | Level S10, S20, S10 Low Opiate, S20 Low Opiate | Level S1, S2, S3, S1 Low Opiate, S2 Low Opiate |
| Analytes | Contains | Contains |
| | Cannabinoids (delta-9-THC) | Cannabinoids (delta-9-THC) |
| | Cocaine (benzoylecgonine) | Cocaine (benzoylecgonine) |
| | Ethanol | Ethanol |
| | Lysergic acid diethamide (LSD) | Lysergic acid diethamide (LSD) |
| | Methadone | Methadone |
| | Methaqualone | Methaqualone |
| | Opiates (morphine, free) | Opiates (morphine, free) |
| | Phencyclidine (PCP) | Phencyclidine (PCP) |
| | Propoxyphene | Propoxyphene |
| | Secobarbital | Secobarbital |
| | Oxazepam | Nordiazepam |
| | d-Methamphetamine | Nortriptyline (TCA) |
| | Does not contain: | d-Amphetamine |
| | Nordiazepam | Does not contain: |
| Nortriptyline (TCA) | Oxazepam | |
| d-Amphetamine | d-Methamphetamine | |

K. Standard/Guidance Document Referenced (if applicable):
The sponsor did not reference any standards in their submission.

L. Test Principle:
Not applicable.

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Not applicable.
b. Linearity/assay reportable range:

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Not applicable.

c. Traceability (controls, calibrators, or method):

Candidate product consists of eight control materials. Controls are human urine spiked with known concentrations of drugs which were gravimetrically prepared. Expected concentrations were verified by reference laboratories. Minimum number of laboratories, replicate measurements, or assay systems is not, however, specified.

Although GC/MS and Enzyme Immunoassay (EIA) analysis is performed during stability studies, (see below), the traceability of control results to GC/MS and EIA is not specified or discussed by the sponsor.

Stability studies are summarized for these controls. Product claims include: (1) open vial: 30 days at 2°C to 8°C, (2) closed vial (Thawed): 45 days at 2°C to 8°C, and (3) shelf life stability: 2 years at -20°C to -70°C. The sponsor specifies the frequency of testing, the method for testing the materials (GC/MS or EIA), environmental conditions of storage, and acceptance criteria for the study (less than 10% variance comparing to time zero). Accelerated stability studies were employed by incubating controls at elevated temperatures (i.e. 25°C, 16°C, 5°C, etc.) to detect alterations in product performance more rapidly than would be seen under normal storage conditions of -20°C to -70°C. Estimated expiration date was predicted using a stability model with activation energy of the 20-kCal/mol or Arrhenius Model. On-going real time studies are long-term and being performed. All procedures appear to be compliance with standard for the industry.

Representative values of the materials are provided and look appropriate.

d. Detection limit:
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.

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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 available.

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

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