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A home drug screening, and if needed, confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: amphetamine, cocaine, methamphetamine, opiates, PCP and THC

Immunoassay for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP and THC in urine.

The Phamatech QuickScreen™ At Home Drug Test (Models 9149 and 9150) is an immunoassay device intended for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, and THC in urine, for use in the home.

Here's an analysis of its acceptance criteria and the supporting study:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, the claim is demonstrating substantial equivalence to existing devices. The reported device performance is measured against predicate devices and analytical methods.

Note: The performance values for each drug are not individually broken out but are reported as general figures across all target drugs.

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

• Sample Size for Test Set: Not explicitly stated. The text mentions "clinical sample correlation study" and "clinical studies" but does not provide the number of specimens used.
• Data Provenance:
  • Clinical Sample Correlation Study: Used "clinical specimens," suggesting real-world samples. The country of origin is not specified but given the manufacturer's location (San Diego, California, USA) and the context of FDA submission, it's highly likely to be U.S. data.
  • Blind Labeled Spiked Study: This study likely used controlled, prepared samples with known drug concentrations (spiked samples).
  • Retrospective/Prospective: Not specified, but "clinical sample correlation study" could imply retrospective analysis of collected samples or prospective collection. The spiked study would be prospective by nature.

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

• The ground truth in the "clinical sample correlation study" was established by comparison to the Behring EMIT II and GC/MS methodology. These are established laboratory methods.
• The "clinical studies" were "performed at two independent laboratories," implying professional users or laboratory personnel.
• The "consumer study" involved "lay users."
• Number of Experts/Qualifications: Not explicitly stated in terms of individual expert numbers or their exact qualifications (e.g., "radiologist with 10 years experience"). However, the use of GC/MS (Gas Chromatography-Mass Spectrometry) implies highly trained analytical chemists or laboratory professionals. Behring EMIT II is also a professional laboratory assay.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly described. Since the ground truth was established by comparison to laboratory methods (Behring EMIT II and GC/MS), this implies a direct comparison rather than an expert consensus adjudication process in the typical sense. For the lay user study, the "accuracy" was likely measured against these same laboratory-confirmed results.

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

• No, an MRMC comparative effectiveness study was not explicitly done in the sense of comparing human readers with and without AI assistance.
• However, the study implicitly compares the device's performance when used by "professional users" vs. "lay users," demonstrating its performance in different user groups. It also compares the device's standalone performance to established laboratory methods and other commercial tests.

6. Standalone Performance (Algorithm Only)

• Yes, a standalone performance study was done. The "clinical sample correlation study" and "blind labeled spiked study" evaluated the QuickScreen™ Test's inherent ability to detect target drugs. The comparison to Behring EMIT II and GC/MS represents the device's performance in isolation from human interpretation variation (though human action is still involved in performing the test).
• The "clinical studies... in the hands of professional users" and "consumer study... in the hands of lay users" evaluate the device's performance with human interaction, but the core measurement is still the device's accuracy.

7. Type of Ground Truth Used

The ground truth used was based on:

• Laboratory Reference Methods: Behring EMIT II (a predicate immunoassay) and GC/MS (Gas Chromatography-Mass Spectrometry), which is considered a gold standard for drug confirmation in many contexts due to its specificity and sensitivity.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. This is common for predicate-based 510(k) submissions for in-vitro diagnostic devices, especially those using established immunoassay technologies. The device's performance is typically evaluated on a test set, and its design would be based on general knowledge of immunoassay development rather than a specific "training set" in the machine learning sense.

9. How Ground Truth for the Training Set Was Established

As no separate training set is mentioned or implied, the question of how its ground truth was established is not applicable in the context of this summary. The device's design and analytical performance rely on the established principles of sandwich immunoassay technology and comparison to recognized predicate devices and laboratory methods.

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