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'RapidOne' - Cocaine Test is a one-step, lateral flow immunoassay for the detection of benzyl ecgonine in urine. 'RapidOne' - Cocaine Test is intended for use in the qualitative detection of benzyl ecgonine in human urine at 300 ng/ml.

'RapidOne' - Cocaine Test is intended for professional use. It is not intended for over the counter sale to non-professionals. The assay is easy to perform, but should not be used without proper supervision. This immunoassay is a simplified qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e., gas-chromatography/mass spectrometry (GC/MS) or HPLC.

'RapidOne' - Cocaine Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The assay employed in the 'RapidOne'- Cocaine Test is based on the same principle of highly specific reaction between antigens and antibodies.

Each assay is a one-step, immunoassay in which a specially labeled drug (drug conjugate) competes with drug which may be present in the sample for the limited number of binding sites on the antibody. The test device consists of a membrane strip onto which a drug conjugate has been immobilized. A colloidal gold-antibody complex is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal goldantibody complex moves with the urine by capillary action to contact the immobilized drug conjugate. An antibody-antigen reaction occurs forming a visible line in the 'test' area. The formation of a visible line in the test area occurs when the test is negative.

When drug is present in the urine sample, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the limited antibody sites on the colloidal gold-antibody complex. If sufficient amount of drug is present, it will fill all of the available binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color band (line) in the test area is indicative of a positive result.

A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence of absence of drug in the urine, and therefore, should be present in all reactions.

A negative urine will produce two colored bands, and a positive sample will produce only one band.

Here's a summary of the acceptance criteria and the study details for the 'RapidOne'- Cocaine Test, based on the provided 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list formal acceptance criteria with specific performance metrics such as sensitivity, specificity, or accuracy targets. Instead, the performance is demonstrated through comparison to a predicate device and evaluation against a stated cut-off concentration.

• Correctly identified all 40 drug-containing samples as positive. |
  | Reproducibility - Negative Urine | >99% agreement for negative samples | 40/40 negative results (>99% precision) when drug concentration was 0 ng/ml. |
  | Reproducibility - Near Cut-off (225 ng/ml) | Not explicitly stated, but high positive rate expected beyond noise for negative. | 20/40 positive results (50% precision) at 225 ng/ml. |
  | Reproducibility - At Cut-off (300 ng/ml) | >99% positive results | 40/40 positive results (>99% precision) at 300 ng/ml. |
  | Reproducibility - Above Cut-off (375 ng/ml) | >99% positive results | 40/40 positive results (>99% precision) at 375 ng/ml. |

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

• Sample Size: 90 samples were used for the comparative evaluation.
  • 50 drug-free samples.
  • 40 drug-containing samples.
• Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective, using selected samples. It does not mention prospective collection or specific geographic locations.

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

• The document does not mention the use of experts to establish the ground truth for individual samples.
• The ground truth for the 40 positive samples was established by GC/MS confirmation and quantification. This is considered the "gold standard" for drug testing.

4. Adjudication Method for the Test Set

• No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The comparison was directly between the test device, the predicate device, and GC/MS results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic test, not an imaging or diagnostic aid that would typically involve multiple human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, this study represents a standalone performance evaluation. The 'RapidOne' - Cocaine Test is a qualitative immunoassay strip, meaning its "algorithm" (the chemical reaction and visual line determination) operates independently. The results are read visually, but the study focuses on the device's inherent ability to detect the analyte based on its chemical principles.

7. The Type of Ground Truth Used

• The ground truth used for the positive samples was confirmatory testing by Gas Chromatography/Mass Spectrometry (GC/MS). For negative samples, the ground truth was "drug-free" status, presumed to be established by prior testing or known origin.

8. The Sample Size for the Training Set

• The document does not specify a separate "training set" sample size. This type of immunoassay device typically relies on established chemical and biological principles and manufacturing controls rather than machine learning models that require distinct training sets. The 90 samples described are for performance evaluation/validation.

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

• As no separate training set is explicitly mentioned for a machine learning context, this question is not directly applicable. If considering the "development" of the device, the ground truth for optimizing the immunoassay would have been based on known concentrations of benzoyl ecgonine, likely confirmed by analytical methods, but details regarding this development process are not provided in the 510(k) summary.

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