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The Beckman Coulter OP 300 Low and High Urine Calibrators, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for the calibration of Opiate 300 ng (Part No. 475024) enzyme immunoassays.

The SYNCHRON® Systems OP 300 Low and High Urine Calibrators are intended for use on SYNCHRON Systems for the calibration of Opiate 300 ng enzyme immunoassays. This product contains a 5.0 mL bottle of the Low Urine Calibrator and a 5.0 mL bottle of the High Urine Calibrator. The storage temperature for the calibrators is +2°C to +8°C.

The OP Low and High Urine Calibrators are ready-to-use human, urine-based. liquid calibrators. They are derived by adding known quantities (traceable to Gas Chromatography/Mass Spectrometry) of morphine (for opiate) to human urine to achieve each drug analyte concentration.

The provided text describes a 510(k) premarket notification for the SYNCHRON® Systems OP 300 Low and High Urine Calibrators. This is a submission for an in vitro diagnostic (IVD) device, specifically calibrators used with enzyme immunoassays for detecting opiates in urine. The nature of this device means the "acceptance criteria" and "study" are focused on analytical performance and comparability to a predicate device, rather than a clinical study evaluating diagnostic accuracy from an AI algorithm.

Here's a breakdown of the information requested, tailored to the context of this IVD calibrator submission:

1. Table of Acceptance Criteria and Reported Device Performance

For an IVD calibrator, the acceptance criteria typically revolve around demonstrating that the new calibrator performs equivalently to a legally marketed predicate device, ensuring similar assay calibration and resulting in comparable analytical performance of the associated assay. The document doesn't explicitly state a "table of acceptance criteria" with numerical targets for performance metrics in the way an AI diagnostic would. Instead, the core of the submission is demonstrating substantial equivalence to the predicate device.

The "performance" in this context refers to the ability of the calibrators to effectively calibrate the Opiate 300 ng enzyme immunoassays on SYNCHRON Systems, yielding results comparable to those obtained using the predicate calibrators.

Based on the provided text, the primary "acceptance criterion" is:

• Substantial Equivalence: The device must demonstrate substantial equivalence to a legally marketed predicate device (SYNCHRON® Systems DAT Low and High Urine Calibrators II, K983747) for its intended use.

The "reported device performance" is implicitly established by the FDA's decision:

• FDA Finding: The FDA reviewed the 510(k) and determined the device is substantially equivalent to the predicate device for the stated indications for use. This implies the submitted data supported this finding.

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

The document does not specify a "test set" in the context of human-subject data for general diagnostic performance. For calibrators, performance is typically evaluated through analytical studies, such as:

• Method Comparison Studies: Comparing results obtained using the new calibrator against the predicate calibrator.
• Accuracy/Trueness Studies: Assessing how closely the calibrated assay measures known concentrations.
• Precision Studies: Evaluating the reproducibility of results.

While the document mentions "adding known quantities (traceable to Gas Chromatography/Mass Spectrometry) of morphine (for opiate) to human urine to achieve each drug analyte concentration," this describes how the calibrators themselves are manufactured and their traceability, not a "test set" sample size for evaluating an algorithm.

Data Provenance: The calibrators are "human, urine-based" liquids. The origin of the human urine used for formulating the calibrators (e.g., country of origin) and whether the data for the equivalency studies were retrospective or prospective are not specified in the provided text.

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

This information is not applicable to this type of device submission. Calibrators are analytical tools; their "ground truth" is established through metrological traceability (e.g., to GC/MS for concentration). There are no human experts "establishing ground truth" for diagnostic performance in the way a radiologist would for an image.

4. Adjudication Method for the Test Set

This information is not applicable for a calibrator submission. Adjudication methods like 2+1 or 3+1 refer to agreement among human readers for diagnostic tasks, which is not relevant here.

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

No, a MRMC comparative effectiveness study was not done. This type of study assesses how AI assistance impacts human reader performance on diagnostic tasks, which is not relevant for a calibrator.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done

Not Applicable. This device is a calibrator, an essential component for an in vitro assay system. It does not perform diagnostic tasks independently or as an algorithm. Its "performance" is its ability to correctly calibrate the associated immunoassay.

7. The Type of Ground Truth Used

For the calibration values within the device, the ground truth is established through:

• Metrological Traceability: Known quantities of morphine, traceable to an accepted reference method like Gas Chromatography/Mass Spectrometry (GC/MS), were added to human urine to achieve specific drug analyte concentrations. This serves as the "ground truth" for the calibrator's assigned values.
• The "clinical significance" section reinforces this: "They are derived by adding known quantities (traceable to Gas Chromatography/Mass Spectrometry) of morphine (for opiate) to human urine to achieve each drug analyte concentration."

8. The Sample Size for the Training Set

This information is not applicable to this type of device. Calibrators are not "trained" in the way AI algorithms are. Their formulation and target values are determined by established analytical chemistry principles and traceability to reference methods.

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

Not Applicable. As there is no "training set" in the AI sense, there is no ground truth established for it. The ground truth for the calibrator's values is established as described in point 7 (metrological traceability to GC/MS).

In summary: The provided document pertains to an IVD calibrator seeking substantial equivalence to a predicate device. The information requested aligns with assessing AI diagnostic devices, which is a different category. Therefore, many of the questions are not directly applicable to a calibrator submission. The critical information for this device is its analytical performance and traceability to reference standards, which underpinned the FDA’s substantial equivalence determination.

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