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Forsure One Step Dip & Read Drug Screen Test is a prescription assay intended for professional use in central laboratories only. It provides qualitative screening results for Amphetamine (AMP), Methamphetamine (MET), Benzodiazepine (BZD), Barbiturate (BAR), Cocaine (COC), Cannabinoids (THC), Opiates (OPI), Phencyclidine (PCP), Methadone (MAD), Oxycodone (OXY), Tricyclic Antidepressant (TCA) and Propoxyphene (PPX) in human urine at the following cutoff levels:

Test: Amphetamine, Calibrator: D-Amphetamine, Cutoff: 1000 ng/ml
Test: Methamphetamine, Calibrator: D-Methamphetamine, Cutoff: 1000 ng/ml
Test: Benzodiazepine, Calibrator: Oxazepam, Cutoff: 300 ng/ml
Test: Barbiturate, Calibrator: Secobarbital, Cutoff: 300 ng/ml
Test: Cocaine, Calibrator: Benzoylecgonine, Cutoff: 300 ng/ml
Test: Cannabinoids, Calibrator: 11-nor-delta9-THC-9 COOH, Cutoff: 50 ng/ml
Test: Opiates, Calibrator: Morphine, Cutoff: 2000 ng/ml
Test: Phencyclidine, Calibrator: Phencyclidine, Cutoff: 25 ng/ml
Test: Methadone, Calibrator: Methadone, Cutoff: 300 ng/ml
Test: Oxycodone, Calibrator: Oxycodone, Cutoff: 100 ng/ml
Test: Tricyclic Antidepressant, Calibrator: Nortriptyline, Cutoff: 1000 ng/ml
Test: Propoxyphene, Calibrator: Propoxyphene, Cutoff: 300 ng/ml

This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly in evaluating a preliminary positive. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.

Forsure One Step Dip & Read Drug Screen Test consists of a or multiple chromatographic absorbent strip 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 through the absorbent strip, the Colloidal Gold labeled antibody- conjugate binds to the free drug in the specimen forming an antibody-antigen complex. This complex competes with immobilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 1000 ng/ml of Amphetamine, 1000 ng/ml of Methamphetamine, 50 ng of THC, 2000ng/ml of Morphine, 300 ng of Benzoylecognine , 25 ng/ml of Phencyclidine, 300 ng/ml of Benzodiazepine, 300 ng/ml of Methadone , 100 ng/ml of Oxycodone , 1000 ng/ml of Tricyclic Antidepressant, 300 ng/ml of Barbiturates and 300 ng/ml of Propoxyphene. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the specific drug test region and control area. A PRELIMINARY POSITIVE specimen produces only one color band in the control area and no color band on the specific drug test region. There is no meaning attributed to color or its intensity for either line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

The provided text, K061617, describes a 510(k) summary for the Forsure One Step Dip & Read Drug Screen Test. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance data in the format requested.

Therefore, much of the requested information regarding acceptance criteria, specific study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment for training sets is not available in the provided text.

However, I can extract the relevant information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the device's ability to detect various drugs at specific cutoff concentrations. While it doesn't explicitly state "acceptance criteria" for a study, these cutoff concentrations define the required performance level for qualitative determination. The "reported device performance" is implicitly that the device does detect these drugs at or above these cutoffs, as demonstrated by its substantial equivalence claim.

Note: The reported device performance is inferred from the statement that the device is "safe and effective for its stated intended use" and "substantially equivalent" to predicate devices, which implies it meets these detection thresholds. No specific sensitivity/specificity, accuracy rates, or detailed concordance percentages are provided for each drug in this summary.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. It is a submission from Tianjin New Bay Bioresearch Co., Ltd., China, but this does not confirm the origin of any test data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable/not specified. The "ground truth" for drug detection is typically established using a reference chemical method, not human experts in this context.
• Qualifications of Experts: Not applicable/not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not specified. The confirmation method mentioned is Gas Chromatography/mass spectrometry (GC/MS).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, an MRMC comparative effectiveness study is not relevant for this type of in-vitro diagnostic device that provides a visual "dip & read" result. The "read" aspect is direct observation of color bands, not interpretation that would require multiple human readers and comparison with AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Was a standalone study done? Yes, the device itself is a "standalone" test. It's an "algorithm only" in the sense that it relies on a chemical reaction to produce a visual result without requiring human interpretation for its primary function. The performance is intrinsically "standalone" as it's a test strip read visually by a single user. The described mechanism ("produces a magenta color band... no color band") indicates a direct chemical outcome.

7. Type of Ground Truth Used

• Type of Ground Truth: The document explicitly states: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method." This indicates that GC/MS is the gold standard used to establish the true presence or absence of drugs, serving as the ground truth.

8. Sample Size for the Training Set

• Sample Size: Not specified in the provided text. As this is an immunoassay device, the concept of a "training set" in the context of machine learning algorithms is not directly applicable. Performance validation for such devices generally involves testing a range of known positive and negative samples, and samples spiked at or around the cutoff.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: As above, GC/MS would be the method for establishing the true concentration of drugs in samples used for any validation or "training-like" processes (e.g., cutoff calibration, cross-reactivity studies) for an immunoassay. However, the document does not detail specific "training set" procedures or how their ground truth was established.

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