Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series

K153474 · Biochemical Diagnostics, Inc. · DIF · Feb 23, 2016 · Clinical Toxicology

Device Facts

• Record ID: K153474
• Device Name: Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series
• Applicant: Biochemical Diagnostics, Inc.
• Product Code: DIF · Clinical Toxicology
• Decision Date: Feb 23, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Indications for Use

The Detectabuse® Liquid control is an In Vitro Diagnostic (IVD) device, for prescription use only, that is intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.

Device Story

Detectabuse® Liquid Control Urine is a stabilized human-based urine product used as an in vitro diagnostic quality control material. It is intended for use in clinical laboratories to monitor the precision of toxicology testing procedures. The device consists of positive controls, gravimetrically spiked with reference drug standards and metabolites, and negative controls, certified negative via immunoassay, GC/MS, or LC/MS. The product is supplied in liquid form and contains sodium azide or a proprietary preservative as a stabilizer. Laboratory personnel use the control to verify the performance of their toxicology assays. By comparing test results of the control against expected values, clinicians ensure the accuracy and reliability of patient drug testing, facilitating informed clinical decision-making regarding toxicology screening.

Clinical Evidence

No clinical data. Bench testing only. Stability studies confirmed performance at 2-8°C (31-day open vial; 3-year closed vial) and -10 to -20°C (up to 4 years). Accuracy validated by SAMHSA/CAP certified laboratories using GC/MS, LC/MS, and immunoassay. Acceptance criteria for target values generally ±15%.

Technological Characteristics

Stabilized human-based urine matrix. Preservatives: sodium azide (<1%) or proprietary manufacturer-approved preservative. Form: liquid. Storage: 2-8°C or -10 to -20°C. Analyte list includes various drugs of abuse, metabolites, and physiological markers (pH, specific gravity, creatinine).

Indications for Use

Indicated for use as quality control urine to monitor precision of laboratory urine toxicology testing procedures. Designed for use under supervision of healthcare professionals as part of good laboratory practices. Compatible with quantitative and qualitative drug detection procedures sensitive to control constituents.

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

• Detectabuse® Liquid Control Urine (k121122)

Submission Summary (Full Text)

{0}

1

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION MEMORANDUM
ASSAY ONLY TEMPLATE

A. 510(k) Number:
k153474

B. Purpose for Submission:
New Device

C. Measurand:
Quality control material for Delta-9-THC-COOH, Benzoylecgonine, Phencyclidine(PCP), Morphine, Morphine -3-glucuronide, 6-Monoacetylmorphine(6-MAM), Codeine, Oxycodone, Buprenorphine, Fentanyl, d-Amphetamine, d-Methamphetamine, 3, 4-Methylenedioxymethamphetamine (MDMA), 3, 4-Methylenedioxyamphetamine (MDA), 3, 4-Methylenedioxy-N-ethylamphetamine (MDEA), Secobarbital, Phenobarbital, Butalbital, Oxazepam, Nordiazepam, Methadone, EDDP, Methaqualone, Propoxyphene, Norproxyphene, Nortriptyline, Cotinine, Ethanol, Creatinine, pH, Specific Gravity Amphetamines, Cannabinoids, Opiates, Barbiturates, Benzodiazepines, Hydrocodone, Buprenorphine glucuronide, Lysergic Acid, Acetaminophen, Tramadol

D. Type of Test:
Not applicable

E. Applicant:
Biochemical Diagnostics, Inc.

F. Proprietary and Established Names:
Detectabuse® Stat-Screen® Liquid Control Urine
Detectabuse® Liquid Control Urine, AU/NZ
Detectabuse® Liquid Control Urine, Immunoassay Series
Detectabuse® Liquid Control Urine, Confirm Series
Detectabuse® Liquid Control Urine, GC/MS
Detectabuse® Liquid Control Urine Series, Single or Multi-Constituent

{1}

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)

H. Intended Use:

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

2. Indication(s) for use:
The Detectabuse® Liquid control is an In Vitro Diagnostic (IVD) device, for prescription use only, that is intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.

3. Special conditions for use statement(s):
This is an in vitro diagnostic device
For prescription use only

4. Special instrument requirements:
Not applicable

I. Device Description:
The Detectabuse® Liquid Controls
Each bottle contains stabilized human based urine. The positive urine controls have been gravimetrically spiked with reference drug standards and /or appropriate metabolites. The negative controls are certified negative by a combination of immunoassay, GC/MS and/or LC/MS for the constituents listed on the target sheets. The products contain less than 1%

{2}

sodium azide as a preservative. For assays sensitive to such as ELISA we substitutes a proprietary preservative approved by the manufacturers and DEA.

# J. Substantial Equivalence Information:

1. Predicate device name(s): Detectabuse® Liquid Control Urine
2. Predicate 510(k) number(s): k121122
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device Detectabuse® liquid Control Urine (k153474) | Predicate Device Detectabuse® liquid Control Urine (k121122) |
| Intended Use | Quality control urine to monitor the performance of laboratory toxicology testing procedure | Same |
| Form | Liquid | Same |
| Matrix | Human urine | Same |
| Differences | | |
| --- | --- | --- |
| Item | Candidate Device Detectabuse® liquid Control Urine (k153474) | Predicate Device Detectabuse® liquid Control Urine (k121122) |
| Analytes | Delta-9-THC-COOH, Benzoylecgonine, Phencyclidine(PCP), Morphine, Morphine -3-glucuronide, 6-Monoacetylmorphine(6-MAM), Codeine, Oxycodone, Buprenorphine, Fentanyl, d-Amphetamine, d-Methamphetamine, 3, 4-Methylenedioxymethamphetamine (MDMA), 3, 4-Methylenedioxyamphetamine (MDA), 3, 4-Methylenedioxy-N-ethylamphetamine (MDEA), Secobarbital, Phenobarbital, Butalbital, Oxazepam, | Delta-9-THC-COOH, Benzoylecgonine, Phencyclidine(PCP), Morphine, Morphine -3-glucuronide, 6-Monoacetylmorphine(6-MAM), Codeine, Oxycodone, Buprenorphine, Fentanyl, d-Amphetamine, d-Methamphetamine, 3, 4-Methylenedioxymethamphetamine (MDMA), 3, 4-Methylenedioxyamphetamine (MDA), 3, 4-Methylenedioxy-N-ethylamphetamine (MDEA), Secobarbital, Phenobarbital, Butalbital, Oxazepam, |

{3}

| Differences | | |
| --- | --- | --- |
| Item | Candidate Device
Detectabuse® liquid Control Urine
(k153474) | Predicate Device
Detectabuse® liquid Control Urine
(k121122) |
| | Nordiazepam, Methadone, EDDP, Methaqualone, Propoxyphene, Norproxyphene, Nortriptyline, Cotinine, Ethanol, Creatinine, pH, Specific Gravity Amphetamines, Cannabinoids, Opiates, Barbiturates, Benzodiazepines, Hydrocodone, , , Buprenorphine glucuronide, Lysergic Acid, , Acetaminophen, Tramadol | Nordiazepam, Methadone, EDDP, Methaqualone, Propoxyphene, Norproxyphene, Nortriptyline, Cotinine, Ethanol, Creatinine, pH, Specific Gravity |
| Storage | Closed vial stable for 36 months when stored at 2-8°C with the exception of oxazepam (oxazepam stable for 6 months), 48 months when stored at -10 to -20°C. Open vial are stable for 31 days when stored at 2-8°C. | Closed vial are stable for 36 months when stored at 2-8°C with the exception of oxazepam, 48 months when stored at -10 to -20°C and protected from light with the exception of oxazepam. Open vial are stable for 30 days when stored at 2-8°C |

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

None were referenced

L. Test Principle:

Not applicable

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):

{4}

5

Traceability:

The controls are validated by certified independent laboratories by using either GC/MS, LC/MS, HPLC, or Immunoassay screening. The controls are manufactured using reference standards purchased from commercial vendors. Accuracy is certified by purity determination using analytical tools including GC/MS, LC/MS, and NMR. Gravimetric preparation is accomplished using balances calibrated with weights that are traceable to National Institute of Standards and Technology (NIST).

Value Assignment:

The following procedure was used for value assignment

a. Assay Methodology used to assign values:
Certified Independent laboratories test by GC/MS, LC/MS, or Immunoassay screening depending on validated test method that is in use at time of testing.

b. Data Collection:
A minimum of 3 data points are collected for each assay. Data collected from at least two test sites, testing performed within 1 week of receipt of test samples.

Stability:

The stability protocols for open and closed vial were reviewed and found acceptable. The testing supports closed vial stability for 36 months when stored at 2-8°C with the exception of oxazepam (oxazepam is stable for 6 months) and 48 months when stored at -10 to -20°C. Open vials are stable for 31 days when stored at 2-8°C and 31 days when stored at room temperature (18-21°C).

d. Detection limit:
Not applicable

e. Analytical specificity:
Not applicable

f. Assay cut-off:

2. Comparison studies:

a. Method comparison with predicate device:
Not applicable

b. Matrix comparison:
Not applicable

{5}

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.

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

6