(243 days)
CEDIA DAU EDDP Assay
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No
The device description and performance studies focus on a chemical assay based on enzyme activity and spectrophotometric measurement. There is no mention of AI or ML in the text.
No
The device is an in vitro diagnostic assay intended for the qualitative and semi-quantitative determination of Methadone Metabolite in human urine. It is used for drug testing and provides analytical results, not therapeutic intervention.
Yes
The device is intended for the qualitative and semi-quantitative determination of Methadone Metabolite in human urine, providing a preliminary analytical test result. This falls under the definition of a diagnostic device as it is used to identify the presence of a substance that can indicate a medical or drug-related condition.
No
The device description clearly outlines the use of liquid reagents and a spectrophotometric method for analysis, indicating a hardware component is necessary for the assay to function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the assay is for the "qualitative and semi-quantitative determination of the presence of Methadone Metabolite (2-ethylidene-1,5-dighenyl-3,3-diphenylpyrrolidine or EDDP) in human urine". This involves testing a sample taken from the human body to provide information about a physiological state (the presence of a drug metabolite).
- Sample Type: The assay is designed to be used with "human urine".
- Methodology: The device utilizes a chemical method (enzyme immunoassay) to detect the presence of a substance in the sample.
- Regulatory Context: The document includes information typically found in regulatory submissions for IVDs, such as performance studies (precision, linearity, interferences, specificity, method comparison) and comparisons to predicate and reference methods (CEDIA DAU EDDP Assay and GC/MS).
These characteristics align directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The DRI Methadone Metabolite (100/300) Assay is intended for the qualitative and semi-quantitative determination of the presence of Methadone Metabolite (2-ethylidene-1,5-dighenyl-3,3-diphenylpyrrolidine or EDDP) in human urine at cutoffs of 100 and 300 ng/mL.
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography / Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. Tests for methadone metabolite cannot distinguish between abused drugs and certain prescribed medications. Certain foods or medications may interfere with test for methadone metabolite and cause false positive results.
The DRI Methadone Metabolite Calibrators are intended for use in calibration of the DRI Methadone Metabolite (100/300) Assay.
The DRI Methadone Metabolite Controls are intended for use in the DRI Methadone Metabolite (100/300) Assay to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects.
Product codes
DJR, DKB, DIF
Device Description
The DRI Methadone Metabolite (100/300) Assay utilizes liquid ready-to-use reagents. The Antibody/Substrate Reagent (R1) contains mouse monoclonal anti-EDDP antibody, glucose-6-phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in Tris buffer with sodium azide as a preservative. The Conjugate Reagent (R2) contains EDDP-derivative labeled with glucose-6-phosphate Enzyme dehydrogenase (G6PDH) in Tris buffer with sodium azide as a preservative.
The assay uses specific antibodies that can detect EDDP in human urine without cross-reactivity to the The assay is based on competition between drug labeled with glucose-6parent drug methadone. phosphate dehydrogenase (G6PDH) and free drug from the sample for a fixed number of specific antibody binding sites. In the presence of free drug from the sample, the free drug occupies the antibody binding sites, allowing the drug-labeled G6PDH to interact with the substrate, resulting in enzyme activity. In the absence of free drug from the sample, the specific antibody binds the drug labeled with G6PDH and causes a decrease in enzyme activity. This phenomenon creates a direct relationship between drug concentration in urine and enzyme activity. This enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sensitivity
Sensitivity measured semi-quantitatively as limit of quantitation (LOQ) was 14 ng/mL.
Precision
A precision study was performed using the CLSI guideline EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition
For qualitative mode, acceptance criteria required that all samples spiked at levels below the cutoff read as negative and all samples spiked at levels above the cutoff read as positive.
For semi-quantitative mode, target within-run precision was less than or equal to 8% CV and target total-run precision was less than or equal to 10% CV.
The within-run and total-run precision at all levels of the 300 cutoff and the 300 cutoff met target specifications in both qualitative and semi-quantitative modes.
Cutoff Characterization - Spike Recovery
In qualitative mode, the control levels were recovered accurately, with the negative controls recovering less than the cutoff calibrators and the positive controls recovering greater than the cutoff calibrators. No overlap was observed between cutoff levels and their ± 25% levels, with 95% statistical confidence. The precision of the 21 replicates was
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
510K SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is: K081378
COMPANY/CONTACT PERSON
Thermo Fisher Scientific Microgenics Corporation 46360 Fremont Blvd. Fremont, CA 94538
Establishment registration No: 2937369
Jack Rogers Manager of Regulatory Affairs Telephone: (317) 610-3823 Fax: (317) 610-0018
DATE PREPARED
December 3, 2008
DEVICE NAME
| Trade Name: | DRI® Methadone Metabolite (100/300) Assay |
|---|---|
| DRI® Methadone Metabolite Urine Calibrators | |
| DRI® Methadone Metabolite Urine Controls | |
| Common Name: | Methadone Test System |
| Device Classification: | 21 CFR 862.3620 Methadone Test System; Class II |
| 21 CFR 862.3200 Clinical Toxicology Calibrator; Class II | |
| 21 CFR 862.3280 Clinical Toxicology Control Material; Class II |
INTENDED USE
The DRI Methadone Metabolite (100/300) Assay is intended for the qualitative and semi-quantitative determination of the presence of Methadone Metabolite (2-ethylidene-1,5-dighenyl-3,3-diphenylpyrrolidine or EDDP) in human urine at cutoffs of 100 and 300 ng/mL.
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography / Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. Tests for methadone metabolite cannot distinguish between abused drugs and certain prescribed medications. Certain foods or medications may interfere with test for methadone metabolite and cause false positive results.
The DRI Methadone Metabolite Calibrators are intended for use in calibration of the DRI Methadone Metabolite (100/300) Assay.
The DRI Methadone Metabolite Controls are intended for use in the DRI Methadone Metabolite (100/300) Assay to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects.
JAN 1 4 2009
1
LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCY IS CLAIMED
The DRI Methadone Metabolite (100/300) Assay is substantially equivalent to the previously cleared CEDIA DAU EDDP Assay (K980746, Microgenics Corporation).
The DRI Methadone Metabolite Calibrators are substantially equivalent to the previously cleared CEDIA DAU Multi-Drug Calibrators (K980853, Microgenics Corporation).
The DRI Methadone Metabolite Controls are substantially equivalent to the previously cleared MGC DAU Control Sets: Primary, Clinical, Select (K040758, Microgenics Corporation).
DESCRIPTION OF DEVICE
The DRI Methadone Metabolite (100/300) Assay utilizes liquid ready-to-use reagents. The Antibody/Substrate Reagent (R1) contains mouse monoclonal anti-EDDP antibody, glucose-6-phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in Tris buffer with sodium azide as a preservative. The Conjugate Reagent (R2) contains EDDP-derivative labeled with glucose-6-phosphate Enzyme dehydrogenase (G6PDH) in Tris buffer with sodium azide as a preservative.
The assay uses specific antibodies that can detect EDDP in human urine without cross-reactivity to the The assay is based on competition between drug labeled with glucose-6parent drug methadone. phosphate dehydrogenase (G6PDH) and free drug from the sample for a fixed number of specific antibody binding sites. In the presence of free drug from the sample, the free drug occupies the antibody binding sites, allowing the drug-labeled G6PDH to interact with the substrate, resulting in enzyme activity. In the absence of free drug from the sample, the specific antibody binds the drug labeled with G6PDH and causes a decrease in enzyme activity. This phenomenon creates a direct relationship between drug concentration in urine and enzyme activity. This enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.
2
2015
:
| Comparison | DRI Methadone Metabolite (100/300)
Assay | Predicate Device - CEDIA DAU EDDP
Assay |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Qualitative and semi-quantitative
determination of the presence of
Methadone Metabolite (2-ethylidene-1,5-
dimethyl-3,3-diphenylpyrrolidine or EDDP)
in human urine at cutoffs of 100 and 300
ng/mL. | Qualitative and semi-quantitative assay of
EDDP (2-ethylidene-1,5-dimethyl-3,3-
diphenylpyrrolidine or EDDP) in human
urine. |
| Test Principle | Homogeneous Enzyme Immunoassay
based on competition between a drug
labeled with glucose-6-phosphate
dehydrogenase (G6PDH) and free drug
from the urine sample for a fixed amount
of specific antibody binding sites, | Homogeneous Enzyme Immunoassay
based on competition between a drug
labeled with ß-galactosidase, and free
drug from the urine sample for a fixed
amount of specific antibody binding sites. |
| | Direct relationship between drug
concentration in urine and enzyme
activity. | Direct relationship between drug
concentration in urine and enzyme
activity. |
| | Enzyme activity is determined
spectrophotometrically at 340 nm by
measuring its ability to convert
nicotinamide adenine dinucleotide (NAD)
to NADH. | Enzyme activity is determined
spectrophotometrically at 570 nm by
measuring its ability to convert CPRG to
CPR. |
| Cutoff | 100 and 300 ng/mL | 100 ng/mL |
| Matrix | Human urine | Human urine |
| Reagents | Liquid Ready-to-Use
Two reagent assay (R1 and R2) | Lyophilized (reconstitution required)
Two reagent assay (R1 and R2) |
| Calibrators | Liquid ready-to-use
(0, 100, 300, 500, 1000 ng/mL) | Liquid ready-to-use
(0, 100, 500, 2000 ng/mL) |
| Controls | Liquid ready-to-use
(± 25% from cutoffs) | Liquid ready-to-use
(± 25% from cutoffs) |
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
10.000
3
SUMMARY OF CLINICAL TESTING
Sensitivity
Sensitivity measured semi-quantitatively as limit of quantitation (LOQ) was 14 ng/mL.
Precision
A precision study was performed using the CLSI guideline EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition
For qualitative mode, acceptance criteria required that all samples spiked at levels below the cutoff read as negative and all samples spiked at levels above the cutoff read as positive.
For semi-quantitative mode, target within-run precision was less than or equal to 8% CV and target total-run precision was less than or equal to 10% CV.
The within-run and total-run precision at all levels of the 300 cutoff and the 300 cutoff met target specifications in both qualitative and semi-quantitative modes.
Cutoff Characterization - Spike Recovery
In qualitative mode, the control levels were recovered accurately, with the negative controls recovering less than the cutoff calibrators and the positive controls recovering greater than the cutoff calibrators. No overlap was observed between cutoff levels and their ± 25% levels, with 95% statistical confidence. The precision of the 21 replicates was