(78 days)
The Beckman Coulter OP 300 Low and High Urine Controls, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for monitoring the quality control for OP 300 ng in the clinical laboratory.
The SYNCHRON® Systems OP 300 Low and High Urine Controls are intended for use on SYNCHRON Systems for the quality control of Opiate 300 ng. This product contains a 5.0 mL bottle of the Low Urine Control and a 5.0 mL bottle of the High Urine Control. The storage temperature for the calibrators is +2℃ to +8℃.
The SYNCHRON® Systems OP Low and High Urine Controls are ready-to-use human, urine-based, liquid controls. 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 document is a 510(k) premarket notification for a medical device: SYNCHRON® Systems OP 300 Low and High Urine Controls. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a comprehensive study report proving the device meets those criteria in the way a new, de novo device might.
Therefore, many of the requested fields cannot be directly answered from this regulatory submission. However, I can extract the available information and explain why other fields are not present.
Acceptance Criteria and Device Performance
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Preamble of Substantial Equivalence | The device is substantially equivalent to legally marketed predicate devices. | This is the overarching "acceptance criterion" for a 510(k) submission. |
| Opiate Level Identity | The opiate level between the candidate and predicate product is identical. Both contain 300 ng and 1000 ng opiate (morphine) analyte. | This is a key point of comparison for substantial equivalence. |
| Material Basis | Both candidate and predicate are human, urine-based, ready-to-use liquid calibrators. | Another key comparison point. |
| Stability Claim | Stress stability studies support an 18-month stability claim. | This is a performance claim made by the manufacturer and is supported by internal data, suggesting the device met a stability criterion. The specific acceptance criteria (e.g., within X% of initial value after 18 months) are not detailed. |
Detailed Study Information (Based on availability in the document):
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document refers to "stress stability studies" and "performance data" but does not quantify the number of samples or runs.
- Data Provenance: Not explicitly stated, though it would be internal Beckman Coulter data as part of their product development and validation process. The country of origin of the data is not mentioned, but the company is US-based. It would be prospective data generated during product development.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable or not stated. For an IVD control, "ground truth" is typically established by the manufacturing process itself (i.e., known concentrations of analytes), and verified by internal quality control and analytical methods. Expert consensus in the traditional sense (e.g., radiologists interpreting images) is not relevant for this type of device.
- Qualifications of Experts: Not applicable.
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Adjudication method for the test set:
- Not applicable/Not stated. Adjudication methods like 2+1 or 3+1 are typically for subjective interpretations, such as clinical image analysis. For an IVD control, the "ground truth" is analytical (known concentration), and performance is assessed against this known value using predetermined analytical methods.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This type of study is completely irrelevant for an in vitro diagnostic control. These controls are used to monitor the performance of analytical instruments (SYNCHRON Systems), not to assist human interpretation of medical images or data in the way AI algorithms do.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is based on the assumption of an AI/algorithm-driven device. The SYNCHRON® Systems OP 300 Low and High Urine Controls are reagents/controls for an analytical instrument. Their "performance" is their ability to perform consistently with known values over their claimed shelf life, within analytical specifications. The concept of "standalone performance" for an algorithm does not apply here. The device itself is the "standalone" control, whose performance is measured by the instrument it is used with.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for these controls is the known, analytically determined concentration of morphine added to the human urine matrix. The document states: "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." This indicates a highly analytical and quantitative method for establishing the "truth."
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The sample size for the training set:
- Not applicable/Not stated. This device is not an AI/ML algorithm that requires a "training set." It is a chemical control product.
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How the ground truth for the training set was established:
- Not applicable (no training set for this type of device). However, as noted in point 6, the ground truth (known concentration) for the manufactured product batches is established through precise addition of analytes, traceable to reference methods like Gas Chromatography/Mass Spectrometry (GC/MS).
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.