← Product Code [LDJ](/productcode/LDJ) · K954497

# FRONTLINE CANNABIS (K954497)

_Boehringer Mannheim Corp. · LDJ · Mar 6, 1996 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K954497

## Device Facts

- **Applicant:** Boehringer Mannheim Corp.
- **Product Code:** [LDJ](/productcode/LDJ.md)
- **Decision Date:** Mar 6, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3870
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

For use in the qualitative analysis of cannabinoids in human urine at a cutoff concentration of 50 ng/mL.

## Device Story

FRONTLINE® CANNABIS is an immunochromatographic test strip for qualitative cannabinoid detection in human urine. Device utilizes Gold Labeled Optical-read Rapid Immuno Assay (GLORIA) technology. Operation involves immersing test strip in urine; capillary action draws sample through a compartment containing colloidal gold-labeled monoclonal antibodies reactive to 11-nor-Δ9-THC-carboxylic acid. Bound analyte-conjugate complex migrates to a detection pad, producing a red color. User visually compares color intensity against a provided scale to classify samples as positive (≥50 ng/mL) or negative. Device is non-instrumented, requires no calibration, and is intended for point-of-care or laboratory use. Visual output allows rapid screening for cannabinoid presence, aiding clinical decision-making regarding substance use.

## Clinical Evidence

Clinical evaluation performed at multiple sites using 761 urine samples compared to EIA and 399 samples compared to FPIA. Comparison to EIA: 243 positive, 500 negative, 14 false positives. Comparison to FPIA: 153 positive, 240 negative, 3 false positives, 2 false negatives. Results confirmed via secondary methods.

## Technological Characteristics

Immunochromatographic test strip; GLORIA (Gold Labeled Optical-read Rapid Immuno Assay) technology. Components: monoclonal antibodies reactive to 11-nor-Δ9-THC-carboxylic acid derivative, colloidal gold conjugate, 11-nor-Δ9-THC-carboxylic acid polyhapten, bulking agents, stabilizers, preservatives. Non-instrumented, visual readout. No external energy source required.

## Regulatory 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 include delta-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.

## Special Controls

*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).

## Predicate Devices

- Emit® d.a.u. Cannabinoid 100 ng Assay
- TDx® Cannabinoids

## Submission Summary (Full Text)

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K954497

# 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 polyhepten, 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 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.

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 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® 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:

Comparison to EIA: A total 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 FRONTLINE® negative when compared to PPIA 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.

# Conclusion:

FRONTLINE® CANNABIS is substantially equivalent to other commercially available cannabinoid test systems.

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**Source:** [https://fda-staging.innolitics.com/device/K954497](https://fda-staging.innolitics.com/device/K954497)

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