(13 days)
The Boehringer Mannheim Precinorm and Precipath® RF Controls are used for the quality control of the Boehringer Mannheim Tinaquant RF assay.
The Boehringer Mannheim Precinorm and Precipath® RF Controls are manufactured using human serum albumin, Rheumatoid Factor, and stabilizers. The analyte is appropriately spiked into the control matrix to the correct control concentration levels. The controls are in process checked, and a value assignment process is done via a comparison to an analyte specific (and chemistry specific) calibrator.
Here's an analysis of the provided text regarding the Boehringer Mannheim Precinorm and Precipath® RF Controls:
Acceptance Criteria and Device Performance Study
Based on the provided document, the device described is a quality control product for an assay, not a diagnostic device that directly measures a patient's condition. As such, the typical metrics for diagnostic devices (sensitivity, specificity, AUC) or AI-powered devices are not applicable or described in this submission.
The "acceptance criteria" for this type of product are focused on its performance as a control material, primarily its ability to provide consistent and accurate values for quality control of the associated assay and its equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence | "Substantially equivalent to other products in commercial distribution intended for similar use." (Specifically, Behring N/T Rheumatology Control SL1, SL2 (K962373)) |
| Matrix Equivalence | "Similar matrix" to the predicate. |
| Dose Assignment | "Equivalent performance to the predicate device." |
| Stability | "Equivalent performance to the predicate device." |
| Manufacturing Process | "The controls are in process checked, and a value assignment process is done via a comparison to an analyte specific (and chemistry specific) calibrator." |
| Analyte Inclusion | Contains Rheumatoid Factor for its intended assay. |
Study Details:
The document describes a 510(k) premarket notification for a new quality control product. The "study" presented is primarily a comparison of the new device to a predicate device to demonstrate substantial equivalence, rather than a clinical trial or performance study with a large patient cohort in the traditional sense of a diagnostic device.
- Type of Study: Substantial Equivalence Comparison. This is a regulatory pathway where a new device is shown to be as safe and effective as a legally marketed predicate device.
- Proof of Equivalence: The document states, "Specific data on the performance of the controls have been incorporated into the draft labeling in attachment 5." However, this attachment with the specific performance data is not provided in the given text. The summary only gives high-level statements about "equivalent performance."
Further Breakdown based on the provided text:
2. Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document refers to "specific data on the performance of the controls" being in an attachment not provided. For a control material, this "test set" would likely involve multiple lots of the control, run across various instruments and reagent lots of the associated assay (Boehringer Mannheim Tinaquant RF assay).
- Data Provenance: Not specified, but generally, such comparison studies are conducted internally by the manufacturer. It's prospective in the sense that the new control material is evaluated against established methods and predicate controls.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the typical sense for this product. For a quality control material, the "ground truth" for its performance is typically established through reference methods, certified reference materials, and rigorous internal validation processes by qualified laboratory personnel, not expert clinical consensus on patient data. The "value assignment process" mentioned is how the expected values for the control are determined.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods are typically used when there's ambiguity in clinical interpretations or diagnostic outcomes. For a quality control material, performance is evaluated against predefined statistical limits and comparative analysis to a predicate.
5. 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. This is not an AI-powered diagnostic device, and therefore, an MRMC study or evaluation of human reader improvement with AI assistance is entirely irrelevant and not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical control material, not an algorithm.
7. The type of ground truth used:
- For the Precinorm and Precipath® RF Controls themselves: The "ground truth" (or target values) for the control material's analytes would be established through a "value assignment process" referenced in the description. This process involves "comparison to an analyte specific (and chemistry specific) calibrator." This implies a traceability to reference standards or highly characterized reference materials.
- For proving substantial equivalence: The predicate device's established performance and intended use serve as a comparative "ground truth."
8. The sample size for the training set:
- Not applicable. This product does not involve machine learning algorithms that require a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set is used.
§ 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.