Who is the manufacturer of ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)?

Tcpi, Inc. filed the 510(k) submission for ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) (K951853).

What is the FDA product code for ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)?

LDJ. It is classified under 21 CFR 862.3870 as a Class 2 device in the Clinical Toxicology panel.

What is the regulatory pathway for ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)

K951853 · Tcpi, Inc. · LDJ · Aug 20, 1996 · Clinical Toxicology

Device Facts

Record ID	K951853
Device Name	ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)
Applicant	Tcpi, Inc.
Product Code	LDJ · Clinical Toxicology
Decision Date	Aug 20, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3870
Device Class	Class 2

Intended Use

This device is intended for medical/forensic screening of urine.

Device Story

Chromatographic absorbent device for qualitative urine drug screening; detects Cannabinoids/metabolites. Principle: competitive immunoassay; drug/metabolites in sample compete with immobilized drug conjugate for limited antibody sites. Labeled antibody-dye conjugate binds free drug; complex migrates up membrane. Positive result: no magenta band at reaction zone (drug >50 ng/ml). Control zone: unbound dye conjugate produces magenta band confirming device function. Used in clinical/forensic settings; operated by laboratory personnel. Output: visual colorimetric band interpretation. Assists healthcare providers/forensic analysts in identifying potential drug presence for further confirmatory testing.

Clinical Evidence

Bench testing: 249 individual urine samples compared against Sigma SIA, Syva Emit, and GC/MS; sensitivity 1.00, specificity 1.00, accuracy 100%. Clinical trial (NIDA certified lab): sensitivity 1.00, specificity 0.9935, accuracy 99.67% vs GC/MS gold standard.

Technological Characteristics

Chromatographic absorbent device; porous membrane support; antibody-dye conjugate; immobilized antigen conjugate. Qualitative visual readout. No electronic components or software.

Indications for Use

Indicated for the qualitative screening of human urine for the presence of Cannabinoids and their metabolites at a cutoff concentration of 50 ng/ml.

Regulatory Classification

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).

Reference Devices

Sigma SIA™ THC
Syva Emit
GC/MS

Related Devices

K963207 — QUICKPAC II ONE STEP MARIJUANA (THC) TEST · Drial Consultants, Inc. · Feb 20, 1997
K992949 — SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST · Drug Detection Devices, Ltd. · Dec 27, 1999
K963654 — QUIKSTRIP ONESTEP MARIJUANA (THC) TEST · Syntron Bioresearch, Inc. · Feb 28, 1997
K971109 — QUIKPAC II ONE STEP AMPHETAMINE TEST · Drial Consultants, Inc. · May 14, 1997
K973269 — QUIKSTRIP ONE STEP BENZODIAZEPINE TEST · Drial Consultants, Inc. · Feb 25, 1998

Submission Summary (Full Text)

{0} K951853 510k Submission for 20 00 One Step™ Urine drug of abuse Cannabinoid Test (THC) - K951853 Technical Chemicals & Products, Inc. Revision A- 4/17/95, B-10/3195, C-3/20/96, printed on 3/20/96 ## 9. Summary of Safety and Effectiveness The sponsor Technical Chemicals and Products Inc. (3340 S.W. 15th Street, Pompano Beach, Florida, 33069) has developed, manufactured and tested under GMP/GLP guidelines a device for the qualitative testing of urine for the presence of Cannabinoids and their metabolites in a screening format. This summary was originally written in May of 1995 and has been updated as of March, 1996 The Trade name of the device is One Step™ Urine Drug of Abuse Cannabinoid Test (THC) having a designated common name of Cannabinoid Test System and a classification as a class II device per 21 CFR 862.3870. This device is intended for medical/forensic screening of urine. TCPI's One Step™ Urine Drug of Abuse Cannabinoids test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 50 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. The sponsor subjected the final product to both in house testing of 249 individual urine samples using both the Sigma SIA™ THC, Syva Emit and GC/MS against the new product. The calculated sensitivity and specificity both equal 1.00 with the accuracy of 100%. Subsequently the device was subjected to a broader clinical trial in a NIDA certified laboratory where the calculated sensitivity equaled 1.00, the specificity equaled 0.9935 and the calculated accuracy equaled 99.67% when compared to the gold standard of GC/MS. Statistical comparisons of all possible combinations of reference methods to the experimental new device failed to identify any significant difference. Additional information on this submission may be obtained by contacting Dr. Cleve W. Laird, Exec Vice President, Technical Chemicals & Products Inc. at 954-979-0400 or by fax at 954-979-0009.