(161 days)
Emit® d.a.u. Opiate Assay, TDx® Opiates
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No
The device description details a traditional immunochromatographic assay with visual interpretation, and there is no mention of AI, ML, or related concepts in the provided text.
No
Explanation: This device is for qualitative analysis of opiates in human urine, which is a diagnostic purpose, not a therapeutic one. It does not treat or alleviate a medical condition.
Yes
The device is described as an "immunochromatographic assay for use in the qualitative analysis of opiates in human urine," which identifies the presence and concentration of a substance (opiates) in a biological sample to aid in diagnosis or screening.
No
The device description clearly outlines a physical test strip utilizing immunochromatographic assay technology with gold-labeled components and visual comparison to a scale. This indicates a hardware-based device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative analysis of opiates in human urine." This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- Device Description: The description details a test strip that analyzes a urine sample to detect the presence of opiates. This process is characteristic of an in vitro diagnostic assay.
- Comparison Studies: The document includes performance studies comparing the device to other established methods (EIA and FPIA) for analyzing urine samples for opiates. This type of validation is typical for IVD devices.
- Predicate Devices: The mention of predicate devices (Emit® d.a.u. Opiate Assay and TDx® Opiates) which are known IVD devices, further supports that this device falls into the same category.
The core function of the device is to diagnose or detect the presence of a substance (opiates) in a sample taken from the human body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
FRONTLINE® OPIATES is a homogeneous immunochromatographic assay for use in the qualitative analysis of opiates in human urine.
Product codes
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Device Description
FRONTLINE® OPIATES is a homogeneous immunochromatographic assay for use in the qualitative analysis of opiates in human urine. The assay is based on Gold Labeled Optical-read Rapid Immuno Assay (GLORIA) technology. Each test strip contains monoclonal antibodies reactive to a morphine derivative labeled with colloidal gold (conjugate) and morphine polyhapten, bulking agents, stabilizers and preservatives (solid phase). When immersed in urine, the test strip absorbs the volume of fluid necessary for the chromatographic reaction to occur. By capillary action, the urine passes through a compartment containing soluble conjugate which specifically binds to the opiate analyte. Excess conjugate is retained by the solid phase in a separate compartment. Only that conjugate with bound opiate analyte passes to the detection pad where a red-colored conjugate-analyte complex is viewed. The color developed on the detection pad is compared visually with a scale provided on the test strip vial. The intensity of the color developed correlates with the concentration of the analyte in the sample and the user may classify the analyte sample as: negative or positive (>=200 ng/mL). FRONTLINE® OPIATES is a noninstrumented assay and requires no user calibration.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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)
Comparison to EIA: A total of 728 metabolized urine samples were evaluated at three sites. 244 samples were FRONTLINE® positive and 482 were FRONTLINE® negative when compared to EIA and the confirmation method. One sample was classified as false positive and one sample was unavailable for confirmation analysis.
Comparison to FPIA: A total of 511 metabolized urine samples were evaluated at two sites. 191 samples were FRONTLINE® positive and 318 were FRONTLINE® negative when compared to FPIA and the confirmation method. Two samples were classified as false positive.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Emit® d.a.u. Opiate Assay, TDx® Opiates
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 - FRONTLINE® OPIATES
| Submitter Name: | Boehringer Mannheim GmbH |
|---|---|
| Submitter Address: | Sandhofer Str. 116 |
| D-68298 Mannheim, Germany | |
| Contact Person: | Richard Naples, Director |
| Regulatory and Government Affairs | |
| Phone Number: | (317) 576-3858 |
| Fax Number: | (317) 845-2324 |
| Date Prepared: | February 29, 1996 |
| Device Trade Name: | FRONTLINE® OPIATES |
| Device Common Name: | Immunochromatographic test for opiates |
| Classification Name: | Opiate test system |
| (per 21 CFR §862.3650) | |
| Predicate Devices: | Emit® d.a.u. Opiate Assay; |
| TDx® Opiates | |
| Device Description: | FRONTLINE® OPIATES is a homogeneous |
| immunochromatographic assay for use in the qualitative | |
| analysis of opiates in human urine. The assay is based on | |
| Gold Labeled Optical-read Rapid Immuno Assay (GLORIA) | |
| technology. Each test strip contains monoclonal antibodies | |
| reactive to a morphine derivative labeled with colloidal gold | |
| (conjugate) and morphine polyhapten, bulking agents, | |
| stabilizers and preservatives (solid phase). When immersed | |
| in urine, the test strip absorbs the volume of fluid necessary | |
| for the chromatographic reaction to occur. By capillary | |
| action, the urine passes through a compartment containing | |
| soluble conjugate which specifically binds to the opiate | |
| analyte. Excess conjugate is retained by the solid phase in a | |
| separate compartment. Only that conjugate with bound | |
| opiate analyte passes to the detection pad where a red- | |
| colored conjugate-analyte complex is viewed. The color | |
| developed on the detection pad is compared visually with a | |
| scale provided on the test strip vial. The intensity of the | |
| color developed correlates with the concentration of the | |
| analyte in the sample and the user may classify the analyte | |
| sample as: negative or positive (≥200 ng/mL). |
SU
:
:
1
Device Technological Characteristics and Comparison to Predicate Devices:
FRONTLINE® is based on Gold Labeled Optical-read Rapid Immuno Assay (GLORIA) technology. Bach test strip contains monoclonal antibodies reactive to a morphine derivative labeled with colloidal gold (conjugate) and morphine polyhapten, bulking agents, stabilizers and preservatives (solid phase). When immersed in urine, the test strip absorbs the volume of fluid necessary for the chromatographic reaction to occur. By capillary action, the urine passes through a
compartment consisting soleble conjugate which specifically binds to the opiate analyte. Excess conjugate is retained by the solid phase in a separate compartment. Only that conjugate with hound onlate analyte passes to the detection pad where a redcolored conjugate analyte complex is viewed. The color developed on the detection pad is compared visually with a scale provided on the test strip vial. FRONTLINE® OPIATES is a noninstrumented assay and requires no user callbration.
Emit® d.a.u. Opiate Assay is an enzyme immunoassay (EIA) based on the competition between analyte in the sample and analyte labeled with an enzyme for antibody binding sites. Results are measured with a suitable instrument based on absorbance changes compared to those generated by defined calibrators.
TDx@ Opiates is a fluorescence polarization immunoassay (FPIA) in which the change in fluorescence polarization due to annibody binding correlates with the concentration of analyte in the sample. Results are measured with a suitable instrument and compared to those generated by defined calibrators.
Commarison to FIA. A rotal of 728 metabolized urine samples were evaluated at three sizes. 244 samples were FRONTLINE® positive and 482 were FRONTLINE@ negative when compared to EIA and the confirmation method. One sample was classified as false positive and one sample was unavailable for confirmation analysis.
Commarison to FPIA: A total of 511 metabolized urine samples were evaluated at rero sites. 191 samples were FRONTLINE® positive and 318 were FRONTLINES negative when compared to FPIA and the confirmation method. Two samples were classified as false positive.
Conclusion:
FRONTLINE® OPIATES is substantially equivalent to other commercially available opiate test systems.
Performance Data:
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