MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT
Device Facts
| Record ID | K040758 |
|---|---|
| Device Name | MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT |
| Applicant | Microgenics Corp. |
| Product Code | DIF · Clinical Toxicology |
| Decision Date | May 28, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3280 |
| Device Class | Class 1 |
Indications for Use
The MGC DAU Control Set consists of unassayed controls intended for use in the validation of drug of abuse assays performed using human urine.
Device Story
MGC DAU Control Sets are liquid, human urine-based control materials containing stabilizers and preservatives; offered in three configurations (Primary, Clinical, Select) with varying analyte concentrations. Used in clinical laboratory settings by technicians to validate drug of abuse assays. Controls are provided at two levels (Low and High) to verify assay performance. Healthcare providers use the results to ensure the accuracy and reliability of patient drug testing. Benefits include standardized quality control for toxicology screening, ensuring consistent assay performance and reliable clinical decision-making regarding drug presence.
Clinical Evidence
No clinical data. Substantial equivalence is based on bench testing and comparison of physical properties and intended use to the predicate device.
Technological Characteristics
Liquid control material prepared in human urine matrix with added stabilizers and preservatives. Two levels (Low and High) provided. Storage at 2°C to 8°C. No software or electronic components.
Indications for Use
Indicated for use as unassayed control material for the validation of drug of abuse assays performed using human urine samples.
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
- Multi-Drug Control Set (K951135)
Related Devices
- K080183 — CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 · Roche Diagnostics Corp. · Mar 25, 2008
- K033366 — LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455 · Bio-Rad · Dec 12, 2003
Submission Summary (Full Text)
{0}
'510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE
A. 510(k) Number: K040758
B. Purpose of Submission: The MGC DAU Control Sets are being modified from it's predicate device Multi-Drug Control Set and DAU Multi-Drug Control
C. Analyte: Primary- Benzoylecgonine, EDDP, d-Methamphetamine, Methadone, Methaqualone, Opiates, Benzodiazapenes, Phencyclidine, Propoxyphene, Barbituates; Clinical- Benzoylecgonine, EDDP, d-Methamphetamine, Methadone, Methaqualone, Opiates, Benzodiazapenes, Phencyclidine, Propoxyphene, Barbituates; Select- 6-Acetylmorphine, Benzoylecgonine, LSD, MDMA, Benzodiazepines.
D. Type of Test: Validation Control Material
E. Applicant: Microgenics Corporation
F. Proprietary and Established Names: MGC DAU Control Sets: Primary, Clinical, and Select
G. Regulatory Information:
1. Regulation section: 21 CFR §862.3280
2. Classification: Class I (general controls)
3. Product Code: DIF
4. Panel: 91
H. Intended Use:
1. Intended use(s):
The MGC DAU Control Set consists of high and low controls intended for use in the validation of drug of abuse assays performed using human urine.
2. Indication(s) for use:
The MGC DAU Control Set is liquid ready-to-use and consists of controls intended for use in the validation of drug of abuse assays performed using human urine.
{1}
3. Special condition for use statement(s): For Prescription Use
4. Special instrument Requirements: The intended instruments are stated in the package insert for primary, clinical, and select configuration.
I. Device Description: Each configuration of the MGC DAU Control Sets is prepared in human urine matrix, with stabilizers and preservatives added. As is shown in the table 1 below, the MGC DAU Control Set is offered in three configurations, known as "Primary", "Clinical" and "Select" differing only in the concentrations and number of analytes offered. Three configurations of MGC DAU Control Set, each consisting of low and high controls will be placed in commercial distribution to satisfy specific requirements of the laboratory community.
Table 1. Three Configurations of MGC DAU Control Set, analytes available and their concentrations
| Configuration | Drug | Low (ng/mL) | High (ng/mL) |
| --- | --- | --- | --- |
| Primary | Benzoylecgonine | 225 | 375 |
| | EDDP | 750 | 1250 |
| | d-Methamphetamine | 750 | 1250 |
| | Methadone | 225 | 375 |
| | Methaqualone | 225 | 375 |
| | Opiates1 | 1500 | 2500 |
| | Benzodiazepenes2 | 225 | 375 |
| | Phencyclidine | 19 | 31 |
| | Propoxyphene | 225 | 375 |
| | Barbituates3 | 225 | 375 |
| Clinical | Benzoylecgonine | 225 | 375 |
| | EDDP | 75 | 125 |
| | d-Methamphetamine | 375 | 625 |
| | Methadone | 225 | 375 |
| | Methaqualone | 225 | 375 |
| | Opiates1 | 225 | 375 |
| | Benzodiazepenes2 | 225 | 375 |
| | Phencyclidine | 19 | 31 |
| | Propoxyphene | 225 | 375 |
| | Barbituates3 | 225 | 375 |
| Select | 6-Acetylmorphine | 7.5 | 12.5 |
| | Benzoylecgonine | 112.5 | 187.5 |
| | LSD | 0.3 | 0.7 |
| | MDMA | 375 | 625 |
| | Benzodiazepenes4 | 225 | 375 |
$^{1}$ Morphine $^{2}$ Oxazepam $^{3}$ Secobarbital $^{4}$ Nitrazepam
{2}
Page 3 of 5
# J. Substantial Equivalence Information:
1. Predicate device name(s):
Multi-Drug Control Set and DAU Multi-Drug Control
2. Predicate K number(s): K951135, and K965157
3. Comparison with predicate:
| Devise Characteristics | Subject Device | Predicate Device (K951135) | Predicate Device (K965157) |
| --- | --- | --- | --- |
| Intended Use | The MGC DAU Control Set consists of controls intended for use in the validation of drug of abuse assays performed using human urine. | The Multi-Drug Controls are for use as unassayed control material with drugs of abuse assays. | The Multi-Drug Controls are for use as unassayed control material with drugs of abuse assays. |
| Analytes | Primary: Benzoylecgonine EDDP d-Methamphetamine Methadone Methaqualone Opiates1 Benzodiazepenes2 Phencyclidine Propoxyphene Barbituates3 | Benzoylecgonine EDDP LSD d-Methamphetamine Methadone Methaqualone Opiates1 Benzodiazepenes2 Phencyclidine Propoxyphene Barbituates3 | Primary: Benzoylecgonine EDDP* LSD d-Methamphetamine Methadone Methaqualone Opiates1 Benzodiazepenes4 Phencyclidine Propoxyphene Barbituates3 |
| | Clinical: Benzoylecgonine EDDP d-Methamphetamine Methadone Methaqualone Opiates1 Benzodiazepenes2 Phencyclidine Propoxyphene Barbituates3 | | Clinical: Benzoylecgonine EDDP* LSD d-Methamphetamine Methadone Methaqualone Opiates1 Benzodiazepenes4 Phencyclidine Propoxyphene Barbituates3 |
| | Select: 6-Acetylmorphine Benzoylecgonine LSD MDMA Benzodiazepenes4 | | Specialty: Benzoylecgonine EDDP* d-Methamphetamine Opiates1 Benzodiazepenes4 Barbituates3 |
| Matrix | Urine | Urine | Urine |
| Control Form | Liquid | Liquid | Liquid |
| Control Levels | Two: Low and High | Two: Low and High | Two: Low and High |
| Storage | 2 °C to 8 °C until expiration date | 2 °C to 8 °C until expiration date | 2 °C to 8 °C until expiration date |
{3}
Page 4 of 5
| Devise Characteristics | Subject Device | Predicate Device (K951135) | Predicate Device (K965157) |
| --- | --- | --- | --- |
| Stability | Until expiration date noted on vial label | Until expiration date noted on vial label | Until expiration date noted on vial label |
¹Morphine ²Oxazepam ³Secobarbital ⁴Nitrazepam
*EDDP was cleared under K023617. It was not included in predicate device K965157, 510(k) submission and was added post-clearance of K965157.
## K. Standard/Guidance Document Referenced (if applicable):
FDA guidance “Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material”.
## L. Test Principle: NA
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
a. **Precision/Reproducibility**: Intra-assay reproducibility (or within-run precision) was determined according to a modified NCCLS protocol (NCCLS EP-5A) by assaying 21 replicates of both low and high controls in commercially available assays for determination of various drugs of abuse. Reproducibility was determined for each of the three configurations using either the representative CEDIA® or DRI® DAU Assay or both assay formats. Intra-assay reproducibility is defined as the coefficient of variation (CV) for the average rate, expressed in milliabsorbance (mA) units, observed for both the High and Low Controls in either the CEDIA®, DRI® or both assay formats. CV is expressed as a percentage, calculated as the standard deviation of the average rate divided by the average and multiplied by 100 (SD/Avg*200). The results provided indicate that the intra-assay reproducibility for the Low and High Controls were all <5% for each configuration in both assay formats.
b. **Linearity/assay reportable range**: NA
c. **Traceability (controls, calibrators, or method)**: No information was provided about traceability.
The MGC DAU Control Set is prepared in human urine. The Control Set consists of low and high controls. Each configuration of the MGC DAU Control Set is formulated in human urine matrix with desired concentration range of each analyte confirmed by gas chromatography with mass spectrometry. Representative GC/MS values for each configuration of the MGC DAU Control Set are provided, and specifications indicate that GC/MS values must be within 90%-110% of target values. Regardless of the configuration, each of the MGCDAU Control Sets is used for validation of drugs of abuse assays. The target concentrations are presented in the Package Insert with appropriate storage instructions.
{4}
Page 5 of 5
Kit Stability: The materials and final formulation for the three configurations of the MGC DAU Control Set are virtually identical to the predicate device, i.e., the Multi-Drug Control Set (K951135), and CEDIA DAU Multi-Drug Control Sets (K965157). As the three configurations of the MGC DAU Control Set are formulated, manufactured and filled in the same manner as the predicate device, we expect the MGC DAU Control Set to exhibit similar stability and, as such, have conservatively defined the shelf life at 12 months stored at 2-8 °C. Modifications to shelf life will be based on results observed from real-time stability studies which are currently in progress.
d. Detection limit: NA
e. Analytical specificity: NA
f. Assay cut-off: NA
2. Comparison studies:
a. Method comparison with predicate device: NA
b. Matrix comparison: NA
3. Clinical studies:
a. Clinical sensitivity: NA
b. Clinical specificity: NA
c. Other clinical supportive data (when a and b are not applicable): NA
4. Clinical cut-off: NA
5. Expected values/Reference range: NA
N. Conclusion:
The submitted material in this premarket notification for MGC DAU Control Sets: Primary, Clinical and Select is complete and supports a substantially equivalence decision.
