TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414

K060788 · Biosite Incorporated · DIF · Jul 10, 2006 · Clinical Toxicology

Device Facts

• Record ID: K060788
• Device Name: TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414
• Applicant: Biosite Incorporated
• Product Code: DIF · Clinical Toxicology
• Decision Date: Jul 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Indications for Use

The Triage TOX Drug Screen Controls are to be used with the Triage TOX Screen tests and Triage Meters to assist the laboratory in monitoring test performance. For prescription use

Device Story

Triage TOX Drug Screen Controls are liquid, human urine-based assayed control materials. They are used in clinical laboratory settings to monitor the performance of Triage TOX Drug Screen tests and Triage Meters. By providing known samples, the controls allow laboratory personnel to verify the accuracy and reliability of the testing system. This monitoring process ensures that the diagnostic equipment is functioning correctly, thereby supporting the validity of patient drug screening results and assisting healthcare providers in making informed clinical decisions regarding drug abuse testing.

Clinical Evidence

No clinical data. Bench testing only. Value assignment and verification were performed by analyzing 90 replicates of each control across three lots and two operators over three days, confirming expected positive/negative results for all analytes.

Technological Characteristics

Liquid human urine matrix. Positive control contains d/l-methadone, acetaminophen, d-amphetamine, d-methamphetamine, pentobarbital, estazolam, desipramine, phencyclidine, morphine, benzoylecgonine, and tetrahydrocannabinol. Concentrations are 2-4 times the assay cutoff. Storage at -20°C or below. Single-use, closed-vial format.

Indications for Use

Indicated for use by laboratory professionals to monitor the performance of Triage TOX Screen tests and Triage Meters for the qualitative detection of drugs of abuse.

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

• Biosite Triage® TOX Drug Screen Controls (K050037)

Submission Summary (Full Text)

{0}

1

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

A. 510(k) Number:
k060788

B. Purpose for Submission:
New device (addition of methadone to an existing toxicology control)

C. Measurand:
Not applicable

D. Type of Test:
Not applicable

E. Applicant:
Biosite, Inc.

F. Proprietary and Established Names:
Triage® TOX Drug Screen Controls

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.3280
2. Classification:
Class I (reserved)
3. Product code:
DIF
4. Panel:
Toxicology (91)

H. Intended Use:
1. Intended use(s):
Refer to Indications for use below.
2. Indication(s) for use:
The Triage TOX Drug Screen Controls are to be used with the Triage TOX Screen tests and Triage Meters to assist the laboratory in monitoring test performance.

{1}

3. Special conditions for use statement(s):

For prescription use

4. Special instrument requirements:

Biosite Triage Meters

I. Device Description:

Level 1 of the Triage TOX Drug Screen Controls is a negative control prepared from drug-free urine. Level 2 is a positive control prepared by adding d/l-methadone, acetaminophen, d-amphetamine, d-methamphetamine, pentobarbital, estazolam, desipramine, phencyclidine, morphine, benzoylecgonine, and tetrahydrocannabinol to human urine. The concentrations for each drug in the positive control are 2-4 times the cutoff concentration of the respective drug assays.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Biosite Triage TOX Drug Screen Controls

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

k050037

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Same | Qualitative control for common drugs of abuse |
| Matrix | Same | Liquid (human urine) |
| Positive control concentrations | Same | 2-4 times cutoff concentration for each analyte |
| Storage | Same | -20°C or below |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Constituents | Same, with the addition of d/l-methadone | acetaminophen, d-amphetamine, d-methamphetamine, pentobarbital, estazolam, desipramine, phencyclidine, morphine, benzoylecgonine, and tetrahydrocannabinol |

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

None referenced

{2}

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):

Traceability
The controls are traceable to commercially available drug-free urine and d/l-methadone. The negative control is drug-free urine with a zero concentration of all analytes. The d/l-methadone is solubilized in distilled water to produce a concentrated stock solution, which is then diluted with drug-free urine to the final concentration of the positive control.

Stability
The sponsor’s real-time stability protocol uses the following formula to calculate recovery at specific storage times at -20°C:

$$
\% \text{ recovery} = \frac{(\text{measured concentration at time point})_{\text{.20C}}}{(\text{measured concentration at time point})_{\text{.70C}}}
$$

The sponsor’s stability criteria are met when all of the time point recoveries at -20°C are within 80 to 120 percent of the recoveries at -70°C or when the trendline recovery lies within an 80 to 120 percent recovery acceptance window.

At the time of submission, the sponsor had collected two weeks of stability data on the controls. On-going real-time stability testing of the controls will continue until the material fails the pre-determined acceptance criteria. The shelf life of the controls will be extended based upon the on-going real-time stability data.

All stability claims are for closed-vial stability only. Open-vial stability is not applicable to this device since it is intended for one time use.

Value Assignment
The negative control consists of drug-free urine and therefore contains none of the drugs of abuse currently available on the Triage system. To add methadone to the previously cleared positive control, a concentrated

3

{3}

stock solution was diluted with drug-free urine to a final concentration of 750 ng/mL (calculated gravimetrically). Values were verified by analyzing 90 replicates of each control using three lots and two operators over three days. All of the negative control replicates produced negative results for all analytes and all of the positive control replicates produced positive results for all analytes.

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

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):

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.