THERMO SCIENTIFIC MAS R DOA TOTAL

K103656 · Microgenics Corporation · DIF · Mar 24, 2011 · Clinical Toxicology

Device Facts

• Record ID: K103656
• Device Name: THERMO SCIENTIFIC MAS R DOA TOTAL
• Applicant: Microgenics Corporation
• Product Code: DIF · Clinical Toxicology
• Decision Date: Mar 24, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Indications for Use

MAS® DOA Total is intended for use as an assayed control for monitoring assay conditions in semi-quantitative and qualitative analysis of patient urine specimens for drugs and drug metabolites. These controls are human urine based and are composed of d-methamphetamine, secobarbital, nitrazepam, oxazepam, buprenorphine, benzoylecgonine, cotinine, ethyl glucuronide, ethanol, LSD, methadone, EDDP, methaqualone, morphine, oxycodone, phencyclidine, propoxyphene, nortriptyline, and L-2-9-THC-COOH. MAS® DOA Total provides 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.

Device Story

MAS® DOA Total is an assayed liquid control material derived from certified drug-free human urine pools, adjusted with purified drugs and metabolites. It serves as a quality control tool for clinical laboratories to monitor the precision and accuracy of drug-of-abuse screening assays. The device provides multiple levels of controls (L1-L6) with analyte concentrations set relative to SAMHSA screening cutoffs. Laboratory personnel use these controls to verify assay performance, detect systematic errors, and identify reagent or instrument defects. By comparing observed results against established target values, clinicians ensure the reliability of patient drug testing results, facilitating accurate clinical decision-making regarding substance use.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (open vial and real-time) and value assignment validation using GC/MS, LC/MS, and EMIT Plus II assays were performed to support performance claims.

Technological Characteristics

Liquid, human urine-based control matrix. Contains stabilized drugs/metabolites. Storage: 2-8°C. Open vial stability: 30 days. Shelf life: 24 months. Analyte values assigned via GC/MS, LC/MS, or EMIT Plus II assays. Traceable to NIST reference standards.

Indications for Use

Indicated for use as an assayed quality control material for monitoring the performance of semi-quantitative and qualitative drug-of-abuse urine assays. No specific patient population is targeted; intended for laboratory use to monitor assay precision and accuracy.

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

• Thermo Scientific MAS DOA-XSE (K971058)

Submission Summary (Full Text)

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

A. 510(k) Number:
k103656

B. Purpose for Submission:
New Device

C. Measurand:
Quality control material for d-methamphetamine, secobarbital, nitrazepam, oxazepam, buprenorphine, benzoylecgonine, cotinine, ethyl glucuronide, ethanol, LSD, methadone, EDDP, methaqualone, morphine, oxycodone, phencyclidine, propoxyphene, nortriptyline, and L- $\Delta^9$-THC-COOH.

D. Type of Test:
Not applicable

E. Applicant:
Microgenics Corporation

F. Proprietary and Established Names:
Thermo Scientific MAS® DOA Total

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DIF | Class I, reserved | 21 CFR 862.3280 | Toxicology |

H. Intended Use:
1. Intended use(s):
See indications for use
2. Indication(s) for use:

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MAS® DOA Total is intended for use as an assayed control for monitoring assay conditions in semi-quantitative and qualitative analysis of patient urine specimens for drugs and drug metabolites. These controls are human urine based and are composed of d-methamphetamine, secobarbital, nitrazepam, oxazepam, buprenorphine, benzoylecgonine, cotinine, ethyl glucuronide, ethanol, LSD, methadone, EDDP, methaqualone, morphine, oxycodone, phencyclidine, propoxyphene, nortriptyline, and L- $\Delta^9$ -THC-COOH.

MAS® DOA Total provides 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.

## 3. Special conditions for use statement(s):

DOA TOTAL offers levels of controls, at concentrations 25% below and 25% above the screening cutoff levels for D-methamphetamine, PCP (Phencyclidine), Opiates, Cocaine and Marijuana (Cannabinoid).

## 4. Special instrument requirements:

Validation studies were conducted using the following methods:

1) GC/MS assays are used for D-methamphetamine, Barbiturate, Nitrazepam, Oxazepam, Buprenorphine, Cocaine, Cotinine, Methadone, EDDP, Methaqualone, Opiates, Oxycodone, PCP, PPX, and THC.
2) LC/MS assays are used for ETG, LSD, and Nortriptyline.
3) EMIT Plus II assay is used for Ethanol.

## I. Device Description:

### Device Description

DOA TOTAL is prepared from confirmed drug free human urine pools. Each pool has been tested using FDA accepted methods and found to be non-reactive for HBsAg, Hepatitis C Antibody (HCV), and HIV-1 and HIV-2 antibody. Analyte levels are adjusted with purified drugs or drug metabolites. Preservatives and stabilizers are added to maintain product integrity.

The DOA Total Liquid Assayed Drugs of Abuse Controls are available by Level, or as a Multi-Pack.

| Catalog Number | Description | Size |
| --- | --- | --- |
| DOAT-1 | Level1
Negative | 6 vials of Level 1, 18 mL per vial |

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| DOAT-2 | Level 2 | 6 vials of Level 2, 18 mL per vial |
| --- | --- | --- |
| DOAT-3 | Level 3 | 6 vials of Level 3, 18 mL per vial |
| DOAT-4 | Level 4 | 6 vials of Level 4, 18 mL per vial |
| DOAT-5 | Level 5 | 6 vials of Level 5, 18 mL per vial |
| DOAT-6 | Level 6 | 6 vials of Level 6, 18 mL per vial |
| DOAT-MP | Multi-pack | 1 vial of Level 1, 18 mL per vial
1 vial of Level 2, 18 mL per vial
1 vial of Level 3, 18 mL per vial
1 vial of Level 4, 18 mL per vial
1 vial of Level 5, 18 mL per vial
1 vial of Level 6, 18 mL per vial |

## J. Substantial Equivalence Information:

1. Predicate device

Thermo Scientific MAS DOA-XSE

2. Predicate K number

K971058

3. Comparison of Technological Characteristics

Similarities and differences between new and predicate devices

| Comparison | Subject Device | Predicate 1 |
| --- | --- | --- |
| Device | MAS DOA Total | MAS DOA-XSE (k971058) |
| Intended Use | MAS® DOA Total is intended for use as an assayed control for monitoring assay conditions in semi-quantitative and qualitative analysis of patient urine specimens for drugs and drug metabolites. | Same |
| Analytes by Configuration | DOA Total: d-Methamphetamine Benzoylecgonine EDDP | DOA XSE: d-Methamphetamine Benzoylecgonine - |

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| | Ethanol
LSD
-
Methadone
Methaqualone
Morphine
Nitrazepam
Oxazepam
PCP
Propoxyphene
Secobarbital
L-Δ⁹-THC-COOH
*Buprenorphine
*Cotinine
*EtG
*Oxycodone
*Nortriptyline
- | Ethanol
LSD
-
Methadone
Methaqualone
Morphine
-
Oxazepam
PCP
Propoxyphene
Secobarbital
L-Δ⁹-THC-COOH
-
-
-
- |
| --- | --- | --- |
| Matrix | Urine Based | Same |
| Form | Liquid ready to use | Same |
| Control Levels | Level 1 Negative
Level 2
Level 3
Level 4
Level 5
Level 6 Elevated High | Level 1 Negative
Level 2 Low
Level 3 High
Level 4 Elevated High |
| Storage | 2-8°C | 2-8°C |
| Open Vial Stability | 30 days | 30 days |
| Shelf Life | 24 months | 24 months |

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:

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Not applicable

b. Linearity/assay reportable range:

Not applicable

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

Traceability:

The drug values in the DOA TOTAL control are determined by certified independent laboratories. With the exception of Ethanol, all analytes are tested by GC/MS or LC/MS. Ethanol was tested by EMIT Plus II assay, since there is no GC/MS or LC/MS method available currently. The assays are calibrated by reference standards 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:

4) GC/MS assays are used for D-methamphetamine, Barbiturate, Nitrazepam, Oxazepam, Buprenorphine, Cocaine, Cotinine, Methadone, EDDP, Methaqualone, Opiates, Oxycodone, PCP, PPX, and THC.

5) LC/MS assays are used for ETG, LSD, and Nortriptyline.

6) EMIT Plus II assay is used for Ethanol.

b. Data Collection:

A minimum of 8 data points are collected for each assay. Data collected from at least two test sites, over at least two separate days in duplicates, are required.

c. Confirmation Value Range:

The sponsor assigned the following value assignment criteria

The high limits of L2 published ranges cannot exceed the 1st cutoff value, and the low limits of L3 published ranges cannot be lower than the 1st cutoff value.

The high limits of L4 published ranges cannot exceed the 2nd cutoff value, and the low limits of L5 published ranges cannot be lower than the 2nd cutoff value.

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# Stability

## Open Vial (5°C) Stability

Three lots of assays containing all levels (3X Level 1-6 vials) were opened with 1 mL sample volume removed twice a week for a total of 30 days to simulate actual customers' usage. On day 31, these samples and their respective samples from unopened vials are assayed to evaluate the product open bottle stability.

Data support the 30-day open bottle stability at 5°C for all analytes in the three pilots evaluated.

## Stress Stability to Predict 5°C Shelf Life

Two elevated temperatures at 41°C and 25°C were used to evaluate stress stability to predict control shelf life at 5°C.

Levels 1 to 6 were incubated at 41°C for 12 days and at 25°C for 90 days. Multiple time points were tested using the staggered start method, and the time to failure (TTF) is determined by linear regression.

Data support the acceptance criteria and hence the recommended 5°C shelf life claim of 24 months.

## Summary table:

| Evaluation Parameter | Acceptance Criteria | Specification | Pass / Fail |
| --- | --- | --- | --- |
| Open Bottle Stability at 5°C | 30 days | L1: Negative
L2-L6: recovery change within +/-10% | Pass |
| Close Bottle Stability – Product Shelf Life (5°C) | 24 months (predicted) | L1: Negative
L2-L5: recovery change within +/-15%
L6: recovery change within +/-20% | Pass |

## Real-time Stability

### Procedure:

Three lots of the assay containing all levels (Levels 1 to 6) controls were stored at 5°C on day zero. Real-time stability monitoring is in process. The

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analyte concentrations of freshly opened vials have been assayed on days 0, 100, 170, 230, and 300 thus far, and studies will continue to establish the 5°C shelf life claim. The point of failure is determined by linear regression.

Real-time stability monitoring for all three lots will be continued to substantiate the above predicted claims.

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):
Not applicable

4. Clinical cut-off:
Not applicable

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5. Expected values/Reference range:

| Analyte | L1 | L2 | L3 | L4 | L5 | L6 | Concentration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| d-Methamphetamine | 0 | 750 | 1250 | 375 | 625 | 2000 | ng/mL |
| Secobarbital | 0 | 225 | 375 | 150 | 250 | 1000 | ng/mL |
| Nitrazepam | 0 | 225 | 375 | 0 | 0 | 0 | ng/mL |
| Oxazepam | 0 | 0 | 0 | 150 | 250 | 1000 | ng/mL |
| Buprenorphine | 0 | 0 | 0 | 15 | 25 | 60 | ng/mL |
| Benzoylecgonine | 0 | 225 | 375 | 112 | 118 | 500 | ng/mL |
| Cotinine | 0 | 375 | 625 | 0 | 0 | 0 | ng/mL |
| ETG | 0 | 375 | 625 | 750 | 1250 | 0 | ng/mL |

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.