(41 days)
The PSA Control is an in vitro diagnostic product intended to be used as a quality control product for the Prostate Specific Antigen (PSA) method on the aca® plus immunoassay system and Dimension® clinical chemistry system with the heterogeneous immunoassay module.
PSA Control is a frozen product containing human PSA-ACT in a bovine serum albumin base. The kit consists of twelve vials, six at each of two levels, containing 5 mL each.
This submission is for a quality control product, the Prostate Specific Antigen (PSA) Control, rather than a diagnostic or therapeutic medical device in the typical sense that would involve patient data, expert interpretations, or specific performance metrics like sensitivity and specificity. Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable.
The "study" in this context is a comparison of the new device to a predicate device to establish substantial equivalence.
Here's an adaptation of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Data Provenance / Comparison Method | Reported Device Performance |
|---|---|---|
| Intended Use Equivalence | Comparison of intended use to predicate device. | Intended use as a quality control product for PSA methods on the Dimension® RxL and aca® plus systems is equivalent to the predicate's use as a control. |
| Analyte Equivalence | Comparison of the analyte controlled for. | Both new device and predicate (aca® plus PSA Control) control for PSA-ACT. |
| Matrix Equivalence | Comparison of the base material. | Both new device and predicate (aca® plus PSA Control) use Bovine Serum Albumin (BSA) as the matrix. |
| Physical Form (Key Difference & Resolution) | Comparison of physical form (new device is frozen, predicate is liquid). The rationale for substantial equivalence implicitly accepts this difference without impacting safety or effectiveness for its intended use as a quality control. The submission explicitly states, "PSA Control is the aca® plus PSA Control with the expanded intended use for the Dimension® RxL clinical chemistry system and with a recommended storage temperature of -10 to -20°C." | The new device is frozen, the predicate is liquid. This difference in physical form is addressed by specifying a new recommended storage temperature (-10 to -20°C) for the new frozen product, and it is deemed substantially equivalent for its intended purpose. |
| Volume per Vial Equivalence | Comparison of content volume. | Both new device and predicate provide 5.0 mL per vial. |
| Number of Levels Equivalence | Comparison of the number of control levels provided. | Both new device and predicate provide 2 levels. (The new device provides "six at each of two levels"). |
| Manufacturing Process / Analyte Sourcing | Statement regarding manufacturing consistency. | "Both the PSA Control for the Dimension® RxL system and the aca® plus PSA Control are manufactured using the same matrix and contain PSA-ACT as the analyte source." This implies the manufacturing process for the core components is similar enough to maintain equivalence. |
| Expanded Intended Use (for new system) | Verification that the control product functions as intended with the new system. (While not explicitly detailed as a separate "study," the expansion of intended use implies internal testing was done to ensure compatibility and performance with the Dimension® RxL). | The expanded intended use specifically includes the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module, indicating it performed adequately for this intended application, otherwise it would not be included in the indications statement. No specific performance data for this expansion is provided in this summary. |
| Safety and Effectiveness Conclusion | Overall conclusion on equivalence. | "PSA Control for the Dimension® RxL system is substantially equivalent to the aca® plus PSA Control based on the comparison summarized above." This is the ultimate "performance" metric for a 510(k) submission of this type. |
Detailed Study Information (as applicable to this 510(k) submission):
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2. Sample Size Used for the Test Set and the Data Provenance:
- This is a premarket notification (510(k)) that establishes substantial equivalence based on comparison to a predicate device, rather than a clinical trial with a "test set" of patient data for performance evaluation.
- The "sample" here refers to the characteristics of the device itself and its predicate. The text states the new device consists of "twelve vials, six at each of two levels, containing 5 mL each." This describes the product's packaging.
- The "study" is a comparison of product specifications and characteristics, not a clinical study involving patients or a test set in the traditional sense.
- Data Provenance: The data comes from the specifications and characteristics of the new device (Dimension® RxL PSA Control) and its predicate (aca® plus PSA Control), provided by Dade International Inc. There is no mention of country of origin for validation data as it's a product comparison. It is considered a prospective submission of information about a new product for regulatory review.
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3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable. Ground truth for a quality control product's substantial equivalence is established by comparing its physical, chemical, and intended use characteristics to a legally marketed predicate, rather than through expert interpretation of clinical results. The "experts" involved are the manufacturer's R&D/regulatory personnel who designed and characterized the device, and the FDA reviewers who assessed the submission.
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4. Adjudication Method for the Test Set:
- Not applicable. There is no "test set" requiring adjudication in this type of submission. The comparison is objective, based on product specifications.
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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:
- Not applicable. This is a quality control product, not an AI-powered diagnostic device, and it does not involve human readers interpreting results.
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6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical quality control reagent, not an algorithm or AI system.
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7. The Type of Ground Truth Used:
- The "ground truth" for this substantial equivalence claim is the legally marketed predicate device (aca® plus PSA Control) and its established characteristics and performance. The new device's specifications (analyte, matrix, volume, levels, intended use) are compared directly to this predicate.
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8. The Sample Size for the Training Set:
- Not applicable. This is a quality control product comparison, not a machine learning model, so there is no training set in that context.
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9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set.
§ 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.