(161 days)
Emit® d.a.u. Cannabinoid 100 ng Assay, TDx® Cannabinoids
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No
The device description details a traditional immunochromatographic assay with visual interpretation, and there are no mentions of AI, ML, or related concepts in the provided text.
No
The device is described as an immunochromatographic assay for the qualitative analysis of cannabinoids in human urine, indicating it is an in-vitro diagnostic device used for testing and not for treating or preventing a disease or condition.
Yes
This device performs qualitative analysis of cannabinoids in human urine to determine if the concentration is above or below a specific cutoff, which is a diagnostic function.
No
The device description clearly outlines a physical immunochromatographic assay with test strips, antibodies, and a visual color comparison method. This is a hardware-based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For use in the qualitative analysis of cannabinoids in human urine". This indicates the device is used to examine a sample taken from the human body (urine) in vitro (outside the body) to provide information about a medical condition or state (presence of cannabinoids).
- Device Description: The description details a "homogeneous immunochromatographic assay" that analyzes "human urine". This further confirms the in vitro nature of the test.
- Anatomical Site: The specified anatomical site is "human urine", which is a biological sample collected from the body for analysis.
These points clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For use in the qualitative analysis of cannabinoids in human urine at a cutoff concentration of 50 ng/mL.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
FRONTLINE® CANNABIS is a homogeneous immunochromatographic assay for use in the qualitative analysis of cannabinoids 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 11-nor-Δ9-THC-carboxylic acid derivative labeled with colloidal gold (conjugate) and 11-nor-Δ9-THC-carboxylic acid 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 cannabinoid analyte. Excess conjugate is retained by the solid phase in a separate compartment. Only that conjugate with bound cannabinoid 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 (≥50 ng/mL).
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 sotal of 761 metabolized urine samples were evaluated at three sites. 243 samples were FRONTLINE® positive and 500 were FRONTLINE® negative when compared to EIA and the confirmation method. Fourteen samples were classified as false positive and four samples were unavailable for confirmation analysis.
Comparison to PPIA: A total of 399 metabolized urine samples were evaluated at two sites. 153 samples were FRONTLINE® positive and 240 were FRONTLINES negative when compared to FPIA and the confirmation method. Three samples were classified as false positive, two samples were classified as false negative, and one sample was unavailable for confirmation analysis.
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. Cannabinoid 100 ng Assay, TDx® Cannabinoids
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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® CANNABIS
| 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® CANNABIS |
| Device Common Name: | Immunochromatographic test for cannabinoids |
| Classification Name: | Cannabinoids test system |
| (per 21 CFR §862.3870) | |
| Predicate Devices: | Emit® d.a.u. Cannabinoid 100 ng Assay; |
| TDx® Cannabinoids | |
| Device Description: | FRONTLINE® CANNABIS is a homogeneous |
| immunochromatographic assay for use in the qualitative | |
| analysis of cannabinoids 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 11-nor-Δ9-THC-carboxylic acid | |
| derivative labeled with colloidal gold (conjugate) and 11-nor- | |
| Δ9-THC-carboxylic acid 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 cannabinoid | |
| analyte. Excess conjugate is retained by the solid phase in a | |
| separate compartment. Only that conjugate with bound | |
| cannabinoid 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 (≥50 ng/mL). | |
| Intended Use: | For use in the qualitative analysis of cannabinoids in human urine |
| at a cutoff concentration of 50 ng/mL. |
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Device Technological Characteristics and Comparison to Predicate Devices:
FRONTLINE® is based on Gold Labeled Optical-read Rapid Immuno Assay (GLORIA) technology. Each test strip conrains monoclonal antibodies reactive to a 1 1-nor-A9-THCcarboxylic acid derivative labeled with colloidal gold (conjugate) and 11-nor-A9-THC-carboxylic acid 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 cannabinoid analyte. Excess conjugate is retained by the solid phase in a separate compartment. Only that conjugate with bound cannabinoid analyte passes to the detection pad where a red-colored conjugate-analyse complex is viewed. The color developed on the detection pad is compared visually with a scale provided on the test strip vial. FRONTLINE@ CANNABIS is a non-instrumented assay and requires no user calibration.
Emit® d.a.u. Cannabinoid 100 ng Assay is an enzyme immunoassay (EIA) based on the competition between analyte in in the sample and analyse 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@ Cannabinoids is a fluorescence polarization immunoassay (FPIA) in which the change in fluorescence polarization due to antibody 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.
Performance Data:
Conclusion:
Comnarison to EIA: A sotal of 761 metabolized urine samples were evaluated at three sites. 243 samples were FRONTLINE® positive and 500 were FRONTLINE® negative when compared to EIA and the confirmation method. Fourteen samples were classified as false positive and four samples were unavailable for confirmation analysis.
Comparison to PPIA: A total of 399 metabolized urine samples were evaluated at two sites. 153 samples were FRONTLINE® positive and 240 were FRONTLINES negative when compared to FPIA and the confirmation method. Three samples were classified as false positive, two samples were classified as false negative, and one sample was unavailable for confirmation analysis.
FRONTLINE® CANNABIS is substantially equivalent to other commercially available cannabinoid test systems.
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