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Opiate 300 ng (OP) Reagent, in conjunction with the SYNCHRON® System OP 300 Urine Calibrators, is intended for the qualitative determination of opiates in human urine, at a cutoff value of 300 ng/mL (morphine), on SYNCHRON Systems.

The Opiate assay provides a rapid screening procedure for determining the presence of opiates in urine. This test provides only a preliminary analytical result: a positive result by this assay should be confirmed by another generally accepted non-immunological method, such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method.12

Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The SYNCHRON Systems Opiate (OP) reagent is designed for optimal SYNCHRON performance on on the CX (CX4/4CE/4A/4PRO, CX5/5CE/5A/5PRO. CX7/7RTS/7Δ/7PRO. CX9ALX/9PRO) and LX (LX20/PRO/LXi) Systems. The reagent kit contains one 250-test cartridge that is packaged separately from the associated calibrators.

Here's an analysis of the provided text regarding the SYNCHRON® Systems Opiate Reagent, focusing on acceptance criteria and study details.

Important Note: The provided text is a 510(k) summary for a medical device. These summaries typically provide a high-level overview of performance data and substantial equivalence to a predicate device. They often do not contain detailed statistical analyses, precise sample sizes for specific tests, or comprehensive descriptions of ground truth establishment to the extent often found in a full scientific publication or detailed study report. The information below is extracted directly from the provided document, and any missing details are due to their absence in the given text.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria for performance metrics (e.g., specific sensitivity, specificity, accuracy targets). Instead, it makes a general statement about equivalency. The primary performance claim is that the device is "substantially equivalent" to a legally marketed predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not specified in the provided text.
   • Data Provenance: Not specified, but the device is intended for "human urine," implying human samples were used. It's common for such tests to use both spiked (controlled concentration) and patient samples, but this is not detailed here. The submission is from the US, for a US market, but the origin of the data is not stated. There is no indication whether the data is retrospective or prospective.

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

   • Not specified. The document states that a positive result should be confirmed by methods like TLC, GC, or GC/MS (with GC/MS being preferred). This implies that these confirmatory methods establish the "ground truth" for ambiguous or positive results, rather than human experts directly interpreting results from the device under review.

3. Adjudication Method for the Test Set:

   • Not applicable as the ground truth appears to be established by analytical confirmatory tests (TLC, GC, GC/MS) rather than expert review. If multiple confirmatory tests were used, a method for reconciling discrepancies (e.g., 2+1, 3+1) might have been employed, but this is not mentioned.

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

   • No. This is an in-vitro diagnostic (IVD) device, specifically a reagent for an automated system. MRMC studies are typically performed for imaging or qualitative diagnostic tests that rely on human interpretation. This device's performance is assessed analytically.

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

   • Yes, this device inherently functions as a standalone algorithm (a reagent on an automated system). Its purpose is to provide a "preliminary analytical result." Human involvement comes after the device provides its result, in the form of clinical consideration and confirmatory testing. The "performance data from validation testing" would be of the algorithm/reagent-system combination itself.

6. The Type of Ground Truth Used:

   • The document implies that the ground truth for determining the actual presence and concentration of opiates is established by "generally accepted non-immunological methods, such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS)." GC/MS is explicitly stated as the "preferred confirmatory method." This falls under analytical/confirmatory testing.

7. The Sample Size for the Training Set:

   • Not specified. The document describes a modification to an existing device (K944606), where "the SYNCHRON Systems Opiate reagent antibody has been modified for drug cross-reactivity." This implies the "training" (development/optimization) involved adjusting the antibody to achieve desired cross-reactivity profiles. The sample size of assays performed during this development phase is not disclosed.

8. How the Ground Truth for the Training Set Was Established:

   • Not explicitly described. For the modification of the antibody's cross-reactivity, ground truth would have been established by preparing samples with known concentrations of various opiates and related compounds (both target and interfering substances). These samples would then be analyzed using reference methods (like GC/MS) to confirm their composition and concentration, allowing researchers to optimize the antibody's performance against these known standards.

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