# K050394: Sure-Screen Amphetamine, Benzodiazepine, Cocaine, Methamphetamine/Mdma, Methadone, Opiates, Phencyclidine & Cannabinoids

- Pathway: 510(k) (Traditional)
- Applicant: Medtox Diagnostics, Inc.
- Decided: Oct 25, 2005 after 251 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K132630: Wondfo Oxazepam Urine Test (Bzo 200) and Wondfo Methamphetamine  Urine Test  (Met 300) (2013), 0 descendants of its own
- K131754: Wondfo Cocaine Urine Test (Coc 100), Wondfo Cannabinoids Urine Test (THC 40) (2013), 0 descendants of its own
- K131232: Wondfo Methadone Urine Test (MTD 200), Wondofo Morphine Urine Test (Mop 100) (2013), 0 descendants of its own

## Indications for use
The SURE-SCREEN Drugs of Abuse Test System uses immunochromatographic test strips for the rapid, qualitative detection of one or more of the following: Amphetamines, Benzodiazepines, Cocaine, Methamphetamine, Methadone, Opiates, Phencyciidine and THC (Cannabinoids) in human urine. It is intended for prescription point-of-care use including workplace settings, criminal justice or forensic settings, drug rehabilitation clinics, physician offices and laboratory settings. SURE-SCREEN is not for over-the-counter sale. Operators that may use this device are defined as individuals with a minimum of a high school education with no formal laboratory training or experience. Individuals should also satisfy the following training and certification guidelines: (1)Training should be conducted by a qualified professional and include a demonstration of the SURE-SCREEN test system and (2) the use of quality assurance samples for monitoring and confirming the performance of the test system. Trainers should observe and confirm that the operator (3) uses proper technique when running a test sample and quality assurance samples, (4) has a basic understanding of test results, including a the potential for false positive and false negative results, (5) knows how to prepare a sample for shipment to the laboratory for confirmation testing, (6) has reviewed the information contained in the MEDTOX SURE-SCREEN Training and Certification Program (available at www.medtox.com and that the operator (7) minimally achieves a score of 80% on the written exam provided by MEDTOX. Operators achieving a score of 80% will be provided with a certificate0of tfi'irkig ' participation. Quality assurance samples appropriate for trainng ar'-vadlblO,( - from MEDTOX Laboratories Inc. Additionally, MEDTOX Technical uppo&rwi!t provide access to assistance from individuals who are experienced the _~ interpretation of drug testing results. Sure-Screen detects drug classes at the following cutoff concentrati ns: (AMP) Amphetamines (d-Amphetamine) 300 ng/ L (BZO) Benzodiazepines (Nordiazepam) 200 ng/mL (COO) Cocaine (Benzoylecgonine) 100 ng/mL (MAMP) Methamphetamine (d-Methamphetamine) 300 ng/mL (MTD) Methadone (Methadone) 200 ng/mL (OPI) Opiates (Morphine) 100 ng/mL (POP) Phencyclidine (Phencyclidine) 925 ng/mL 9 40 ng/mL (THC) Cannabinoids (11-nor-9-carboxy-A -THC) Many of the cutoff concentrations for these tests are below those recommended by SAMHSA. Additionally, many of these tests are positive at levels significantly below the claimed cutoff concentration. The rate of false positive results with tests having sensitivities this low has not been studied. However, the rate of false positives generally increases as the cutoff concentration of the test is lowered. See the Precision/Sensitivity section for more information. The SURE-SCREEN drugs of abuse test system provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GCIMS) or liquid chromatography/tandem mass spectrometry (LC/MSIMS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result. It is the responsibility of those organizations required to follow Department of Transportation (DOT) or Substance Abuse Mental Health Services Administration (SAMHSA) Workplace Drug Testing Guidelines to determine that use of this product satisfies the criteria for workplace testing established under DOT and SAMHSA authority.

Source page: https://510kreport.com/device/K050394
Methodology: https://510kreport.com/methodology