(104 days)
Not Found
No
The device description details a homogeneous enzyme immunoassay based on competitive binding and enzymatic reactions. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or decision-making. The performance studies focus on standard analytical chemistry metrics.
No.
The device is used for the qualitative assay of opiates in human urine, which aids in diagnosis and treatment, but it is an in-vitro diagnostic device and not a therapeutic device itself.
Yes
The "Intended Use / Indications for Use" states that "Measurements are used in the diagnosis and treatment of opiate use or overdose." This explicitly indicates the device's role in diagnosis.
No
The device description clearly outlines a homogeneous enzyme immunoassay which involves chemical reagents and reactions to measure opiates in urine. This is a laboratory-based test requiring physical components and processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is for the "qualitative assay of opiates in human urine" and that "Measurements are used in the diagnosis and treatment of opiate use or overdose." This clearly indicates that the device is intended to be used in vitro (outside the body) to analyze a biological sample (urine) for diagnostic purposes.
- Device Description: The "Device Description" further reinforces this by describing a "homogeneous enzyme immunoassay used for the qualitative measurement of opiates in urine." This describes a laboratory test performed on a sample.
- Performance Studies: The "Summary of Performance Studies" details various performance characteristics relevant to a diagnostic test, such as Precision, Sensitivity, Accuracy, and Specificity. These are standard metrics for evaluating the performance of IVD devices.
The definition of an IVD is a medical device that is intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. The CEDIA DAU Opiate 2K Assay fits this definition perfectly.
N/A
Intended Use / Indications for Use
The CEDIA DAU Opiate 2K Assay is a homogeneous enzyme immunoassay for the qualitative assay of opiates in human urine. Measurements are used in the diagnosis and treatment of opiate use or overdose.
Product codes
Not Found
Device Description
The CEDIA® DAU Opiate 2K Assay is an in-vitro homogeneous enzyme immunoassay used for the qualitative measurement of opiates in urine. It is based on competitive binding concepts employing morphine derivative labeled enzymatic fragments (ß-galactosidase) competing with sample morphine for the morphine-specific antibody.
Using recombinant DNA techniques, the β-galactosidase molecule has been split into two totally inactive polypeptide subunits called enzyme acceptor and enzyme donor. Morphine has been covalently linked to the enzyme donor in a manner that does not prevent spontaneous reassociation of the subunits to yield active β-galactosidase enzyme. Morphine-specific antibody, by binding to the morphine on the enzyme donor will inhibit enzyme reassociation, thereby regulating the level of β-galactosidase formed. The amount of enzyme formed is proportional to the amount of opiates as monitored by the hydrolysis of the substrate chlorophenol red-β-D-galactopyranoside (CPRG).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Precision: The Modified NCCLS (mA/min) for CEDIA DAU Opiate 2K at 1500 concentration level (N=120) showed a Within-Run %CV of 1.3 and Total %CV of 4.6. At 2000 concentration level (N=120), Within-Run %CV was 1.4 and Total %CV was 5.0. At 2500 concentration level (N=120), Within-Run %CV was 1.3 and Total %CV was 4.4.
Sensitivity (LOD): 60.9 ng/mL for CEDIA DAU Opiate 2K.
Accuracy Relative: 70.6% of CEDIA DAU Opiate for CEDIA DAU Opiate 2K.
Specificity Relative: 100% of CEDIA DAU Opiate for CEDIA DAU Opiate 2K.
Interfering substances: Less than 10% error in drug detection at glucose= 3 g/dL, sodium chloride= 6 g/dL, protein= 0.5 g/dL, and urea= 5 g/dL.
Specificity (Major Detectables): Morphine, Morphine-3-glucuronide, Codeine, Hydrocodone, Hydromorphone, 6 Monoacetylmorphine.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity (LOD): 60.9 ng/mL
Accuracy Relative: 70.6% of CEDIA DAU Opiate
Specificity Relative: 100% of CEDIA DAU Opiate
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).
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510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. | |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| 1) Submitter
name,
address,
contact | Boehringer Mannheim Corporation
2400 Bisso Lane
Concord, CA 94524
(510) 674-0667
Contact Person: Betsy Soares-Maddox
Date Prepared: September 18, 1996 | |
| 2) Device
name | Proprietary name: CEDIA DAU Opiate 2K Assay
Common name: Homogeneous enzyme immunoassay for the determination of
opiate levels in urine.
Classification name: Opiate test system | |
| 3) Predicate
device | We claim substantial equivalence to the CEDIA DAU Opiate Assay
(K935346). | |
| 4) Device
Description | The CEDIA® DAU Opiate 2K Assay is an in-vitro homogeneous enzyme
immunoassay used for the qualitative measurement of opiates in urine. It is
based on competitive binding concepts employing morphine derivative labeled
enzymatic fragments (ß-galactosidase) competing with sample morphine for
the morphine-specific antibody. | |
| 4) Device
Description,
cont. | Using recombinant DNA techniques, the β-galactosidase molecule has been
split into two totally inactive polypeptide subunits called enzyme acceptor and
enzyme donor. Morphine has been covalently linked to the enzyme donor in a
manner that does not prevent spontaneous reassociation of the subunits to yield
active β-galactosidase enzyme. Morphine-specific antibody, by binding to the
morphine on the enzyme donor will inhibit enzyme reassociation, thereby
regulating the level of β-galactosidase formed. The amount of enzyme formed
is proportional to the amount of opiates as monitored by the hydrolysis of the
substrate chlorophenol red-β-D-galactopyranoside (CPRG). | |
| 5) Intended
use | The CEDIA DAU Opiate 2K Assay is a homogeneous enzyme immunoassay
for the qualitative assay of opiates in human urine. Measurements are used in
the diagnosis and treatment of opiate use or overdose. | |
| 6)
Comparison
to predicate
device | The Boehringer Mannheim CEDIA DAU Opiate 2K Assay is substantially
equivalent to other products in commercial distribution intended for similar
use. Most notably it is substantially equivalent to the currently marketed
Boehringer Mannheim CEDIA DAU Opiate Assay. | |
| | The following table compares the CEDIA DAU Opiate 2K Assay with the
predicate device, CEDIA DAU Opiate Assay. Specific data on the
performance of the test have been incorporated into the draft labeling in
attachment 5. Labeling for the predicate device is provided in attachment 6. | |
| | Similarities: | |
| | • Both assays use the same CEDIA DAU Enzyme Acceptor, Enzyme
Donor and Enzyme Donor Buffer components. | |
| | • Both assays utilize the same antibody | |
| | • Both assays are used on the BM/Hitachi 717 analyzer using the same
chemistry parameters. | |
| | • Both assays are for the determination of opiates in urine. | |
| | Continued on next page | |
| Feature | CEDIA DAU Opiate 2K | CEDIA DAU Opiate |
| Cutoff Level | 2000 ng/mL | 300 ng/mL |
| Antibody
Concentration | 13 µg/mL | 3 µg/mL |
| Intended Use | Qualitative | Qualitative and
semiquantitative |
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510(k) Summary, Continued
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510(k) Summary, Continued
Differences:
Comparison to predicate device, cont.
Performance Characteristics:
| Feature | CEDIA DAU Opiate 2K | CEDIA DAU Opiate | ||||
|---|---|---|---|---|---|---|
| Precision | Modified NCCLS (mA/min): | Modified NCCLS (mA/min): | ||||
| Concentration | ||||||
| Level | 1500 | 2000 | 2500 | 225 | 300 | 375 |
| N | ||||||
| Within-Run | ||||||
| %CV | ||||||
| Total | ||||||
| %CV | 120 | |||||
| 240.1 | ||||||
| 1.3 | ||||||
| 240.1 | ||||||
| 4.6 | 120 | |||||
| 296.8 | ||||||
| 1.4 | ||||||
| 296.8 | ||||||
| 5.0 | 120 | |||||
| 353.8 | ||||||
| 1.3 | ||||||
| 353.8 | ||||||
| 4.4 | 120 | |||||
| 269.8 | ||||||
| 1.6 | ||||||
| 269.8 | ||||||
| 4.2 | 120 | |||||
| 316.8 | ||||||
| 1.4 | ||||||
| 316.8 | ||||||
| 4.8 | 120 | |||||
| 361.4 | ||||||
| 1.3 | ||||||
| 361.4 | ||||||
| 4.2 | ||||||
| Sensitivity | ||||||
| (LOD) | 60.9 ng/mL | 21.6 ng/mL | ||||
| Accuracy | ||||||
| Relative | ||||||
| Sensitivity | ||||||
| Relative | 70.6% of CEDIA DAU Opiate | 100% of Emit® II | ||||
| Specificity 100% of CEDIA DAU Opiate | 100% of Emit® II |
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| Interfering
substances | Less than 10 % error in drug
detection at: | Less than 10 % error in drug
detection at: |
|---------------------------|-----------------------------------------------|-----------------------------------------------|
| Glucose=
Sodium | 3 g/dL | 3 g/dL |
| Chloride= | 6 g/dL | 6 g/dL |
| Protein= | 0.5 g/dL | 0.5 g/dL |
| Urea= | 5 g/dL | 6 g/dL |
| Feature | CEDIA DAU Opiate 2K | CEDIA DAU Opiate |
|---|---|---|
| Specificity | Major Detectables: | Major Detectables: |
| Morphine | ||
| Morphine-3-glucuronide | ||
| Codeine | ||
| Hydrocodone | ||
| Hydromorphone | ||
| 6 Monoacetylmorphine | Morphine | |
| Morphine-3-glucuronide | ||
| Codeine | ||
| Hydrocodone | ||
| Hydromorphone | ||
| 6 Monoacetylmorphine |