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'Rapid Drug Screen' 9-Panel is a one-step, lateral flow immunoassay for the simultaneous detection of 8 abused substances and tricyclic antidepressants in urine. The "Rapid Drug Screen" 9-Panel test is intended for use in the qualitative detection of the following 9 drugs in human urine at the following levels:

d-Amphetamine 750 ng/ml
Barbiturates 300 ng/ml
Benzodiazepines 300 ng/ml
Benzoyl ecognine 225 ng/ml
Cannabinoids (11-nor-9-carboxy-delta-9-THC) 50 ng/ml
Methamphetamine 1000 ng/ml
Opiates (codeine) 225 ng/ml
(morphine-3-glucuronide) 225 ng/ml
Phencyclidine (PCP) 19 ng/ml
Tricyclic Antidepressants 1000 ng/ml

'Rapid Drug Screen' 9-Panel is intended for use by professional laboratories. The assay 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).

'Rapid Drug Screen' 9-Panel 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.

All of the assays employed in the Rapid Drug Screen 9-Panel are based on the same principle of the 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 an 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 gold-antibody 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-labeled 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.

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Acceptance Criteria and Device Performance Study for K992033: 'Rapid Drug Screen' 9-Panel

1. Table of Acceptance Criteria and Reported Device Performance

The device is a qualitative screening method; therefore, the primary performance criteria are sensitivity (correctly identifying positive samples) and specificity (correctly identifying negative samples) relative to a reference method at specific cut-off concentrations. The document defines the target cut-off levels for each drug as its acceptance criteria.

Summary of Performance Study:
The study compared the 'Rapid Drug Screen' 9-Panel to two predicate devices: American BioMedica 'Rapid Drug Screen' 9-Panel test kit (K983770) and Biosite Diagnostics' Triage® Panel for Drugs of Abuse plus Tricyclic Antidepressants (K955935), and to Syva EMIT-II for initial positive identification.

• Positive Agreement: The device "correctly identified all of the… 40 drug-containing specimens to be positive" when compared to Syva EMIT-II.
• Negative Agreement: The device "correctly identified all of the… fifty (50) of which were found to be drug-free" when compared to predicate devices/Syva EMIT-II.
• Reproducibility: Evaluated using control urines containing concentrations above and below the stated cut-off, as well as negative controls. The results "confirmed the reproducibility of the Rapid Drug Screen 9-Panel performance."

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

• Test Set Size: 90 samples.
  • 50 drug-free samples.
  • 40 drug-containing samples.
• Data Provenance: Not explicitly stated (e.g., country of origin, demographics). The samples were "selected for evaluation," implying they were pre-collected. The study is retrospective in the sense that existing samples (either drug-free or pre-identified as positive by EMIT-II) were used. It does not mention prospective collection or controlled spiking of samples to reach specific concentrations for evaluation against the cut-offs, though reproducibility was checked with control urines "above and below the stated cut-off."

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

Not applicable in the typical sense for this type of IVD device. The ground truth for the drug-containing samples relied on a laboratory method for detection, not expert human interpretation of images or other data.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by laboratory methods (Syva EMIT-II for initial screening of positives, HPLC for confirmation of identification but not quantification).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is a point-of-care or laboratory screening immunoassay; human "readers" are not involved in interpreting complex data, but rather a simple visual presence or absence of a line. The comparison was device-to-device and device-to-laboratory method, not reader-to-reader.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, this is a standalone device study. The device itself (the immunoassay) provides the result based on chemical reactions. A human merely reads the visual output (presence or absence of a line). The study evaluates the performance of the device itself.

7. The Type of Ground Truth Used

The ground truth was established using established laboratory methods:

• Initial screening for positive samples: Syva EMIT-II.
• Confirmation for positive samples: HPLC (identified but not quantified).
• For reproducibility: "Control urines containing concentrations above and below the stated cut-off" and "Negative controls."

8. The Sample Size for the Training Set

Not applicable. This device is an immunoassay, not a machine learning algorithm that requires a training set. Its performance is based on the chemical specificity and sensitivity of the antigen-antibody reactions embedded in its design.

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

Not applicable, as there is no training set for an immunoassay.

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