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Syntron's QuikStrip DipScan X Multidrug Screening Device (the X is replaced by 2, 3, 4, 5, or 6) is a holder for up to six rapid, qualitative, competitive, binding immunoassay strips for the detection of drugs of abuse and their metabolites in urine at the SAMHSA designated GC/MS cutoff levels. The test strips available for inclusion in the DipScan are Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates, and Phencyclidine (PCP). The tests provide only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. Syntron's QuikStrip DipScan X Multidrug Screening Device is not intended to monitor drug levels, but only to screen for the presence of drugs of abuse and their metabolites.

The sponsor, Syntron Bioresearch, Inc. (2774 Loker Ave. West, Carlsbad, California, 92008), has developed, manufactured, and tested under GMP/GLP guidelines a Strip Holder that will accommodate 2 to 6 of the company's cleared drugs of abuse strips for the qualitative detection of drugs of abuse and their metabolites in a quick, simple, easy to read, screening format. Test strips available for inclusion in the DipScan X also comprises Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates (300), and Phencyclidine (PCP).

Syntron's QuikStrip DipScan X Multidrug Screening Device (X is replaced by 2, 3, 4, 5, or 6) consists of two to six (2-6) individual test strips on which the drug or drug metabolites in the chromatographic absorbent device is immobilized on a porous membrane support for the limited antibody sites for each drug. As the test sample flows up the support the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody antigen complex. This complex, different for each drug, competes with immobilized antigen conjugate in the test zone and will not produce a magenta color band when the drug is above the detection level specified by SAMHSA for GC/MS (Note the cutoff for opiates used in the opiate test strips was 300 ng/ml instead of the new cutoff of 2000 ng/ml for opiates and in the conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. Each of the test strips in the holder functions independently and is read independently. Test strips available for inclusion in the DipScan X are Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates (300), and Phencyclidine (PCP).

Here's a breakdown of the acceptance criteria and study information for the QuikStrip DipScan X Multidrug Screening Device, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are implicitly tied to its ability to detect specific drugs of abuse or their metabolites in urine at SAMHSA (Substance Abuse and Mental Health Services Administration) designated GC/MS cutoff levels. The "reported device performance" is a general statement about the device's intended function rather than specific metrics in this document.

Study Details:

1. Sample Size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided text.
   • Data Provenance: The text states "In-house testing," suggesting the data was generated internally by Syntron Bioresearch, Inc. The country of origin is implicitly the USA, where Syntron Bioresearch is located (Carlsbad, California). The study is retrospective in the sense that the data was generated prior to the 510(k) submission, but it's not explicitly stated if it was a retrospective analysis of existing samples or prospective testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified. The ground truth for cutoff levels is referenced to SAMHSA designated GC/MS cutoff levels, implying that these established external standards (likely from expert consensus or validated methods) serve as the ground truth.

3. Adjudication method for the test set:

   • Not applicable/specified. The device is a qualitative diagnostic test that directly produces a positive/negative result based on a chemical reaction. The "ground truth" reference to SAMHSA GC/MS cutoffs suggests a comparison against an objective, established standard rather than human adjudication of interpretive results.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, a MRMC study was not done. The device is a "screening device" that provides a "quick, simple, easy to read, screening format" with a direct visual output (presence or absence of a magenta band). It is designed for individual use and interpretation, not for complex medical imaging interpretation or scenarios where multiple human readers might disagree and benefit from AI assistance. Therefore, there's no discussion of human reader improvement with or without AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, the device's basic "in-house testing" provides standalone performance. The device itself performs the detection without human interpretive input beyond reading the color band. The description of how the device functions (antibody-dye conjugate binding, competition with immobilized antigen conjugate, magenta band indication) is a description of its standalone mechanistic operation.

6. The type of ground truth used:

   • The primary ground truth referenced is SAMHSA designated GC/MS cutoff levels. This implies comparison to a highly accurate and standardized analytical method (Gas Chromatography/Mass Spectrometry), which is considered a gold standard for drug detection and quantification. The document mentions an exception for Opiates (300 ng/ml cutoff was used instead of a new cutoff), which suggests adherence to a specific, recognized standard.

7. The sample size for the training set:

   • Not specified. The provided text describes the device and its intended use, along with limited "in-house testing" results. There is no mention of a "training set" in the context of machine learning or AI, as this device appears to be a chemical immunoassay, not an AI-driven diagnostic.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no mention of a "training set" or AI/machine learning aspects for this device. The device's mechanism is based on established immunochemical principles.

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