(34 days)
The "Wiener lab. Standatrol S-E 2 niveles" 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. It may also be used for proficiency testing in interlaboratory surveys. This quality control material is used for monitoring accuracy and precision both for manual techniques and assays on automated clinical chemistry analyzers.
Standatrol S-E 2 niveles consists of lyophilized human serum containing the analytes usually determined in clinical chemistry laboratories. The exact concentrations and acceptable ranges of the components are lot-specific and are provided in the product insert.
The provided text describes the Wiener lab. Standatrol S-E 2 niveles, a quality control material, and its substantial equivalence to a predicate device, ROCHE Precinorm U and Precipath U. It does not contain information about studies proving the device meets specific acceptance criteria in the way a diagnostic device performance study would. Instead, the focus is on demonstrating "substantial equivalence" to a legally marketed predicate device.
Here's an attempt to answer based on the provided text, acknowledging that some requested information for a typical diagnostic device performance study is not present:
This submission demonstrates the substantial equivalence of the "Wiener lab. Standatrol S-E 2 niveles" to existing predicate devices, rather than a study proving the device meets specific performance criteria through novel testing.
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A table of acceptance criteria and the reported device performance
The document does not present explicit acceptance criteria or reported device performance in terms of sensitivity, specificity, accuracy, etc. for the Wiener lab. Standatrol S-E 2 niveles. Instead, it provides a comparative table highlighting similarities and some minor differences with the predicate device, ROCHE Precinorm U and Precipath U, to establish substantial equivalence.
Feature / Characteristic Predicate Device (ROCHE Precinorm U and Precipath U) Wiener LAB. Standatrol S-E 2 niveles Acceptance (based on equivalence) Intended Use For quality control in the quantitative determination of substrates, electrolytes, lipids, enzymes and proteins. Intended for use as assayed control material for automated and manual clinical chemistry methods. Equivalent (minor wording difference, same underlying purpose) Format Lyophilized pooled human sera with constituents added as required to obtain desired components levels. Lyophilized pooled human sera with constituents added as required to obtain desired components levels. Equivalent Stability (Provided Reagents) Stable in refrigerator (2-8°C) until expiration date. Stable in refrigerator (2-10°C) until expiration date. Equivalent (slight temperature range difference but within typical refrigerated storage) Stability (Reconstituted) Stable for 12 hours at 25°C, 5 days at 4°C or 1 month frozen (-20°C), with exceptions noted in label. Stable for 5 days at 2 - 10°C or 1 month frozen (-20°C), with exceptions noted in label. Equivalent (differences are noted in product labeling) Levels Two Levels. Two Levels. Equivalent Constituent Analytes and Enzymes Includes a list of 25 analytes/enzymes. Includes a list of 24 analytes/enzymes (missing total Iron-binding capacity, other electrolytes, other enzymes present in predicate; adds HDL-Cholesterol). Substantially Equivalent (minor differences in specific analytes, but overall scope of use is similar) -
Sample size used for the test set and the data provenance
The document does not describe a "test set" for performance evaluation in the typical sense of a diagnostic device. The evaluation is based on comparing the characteristics of the new device to a predicate device. There is no mention of a specific sample size of materials tested from different countries or whether the comparison was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" for a test set was established by experts in this context. The claim is based on the characteristics of the control material itself and its similarity to an established product.
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Adjudication method for the test set
Not applicable. No adjudication method for a test set was described.
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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
Not applicable. The device is a quality control material, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a quality control material, not an algorithm.
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The type of ground truth used
The concept of "ground truth" as typically used in diagnostic device studies (e.g., pathology, outcomes data) is not directly applicable here. The "evidence" for substantial equivalence is derived from a direct comparison of the physical and functional characteristics of the new device with the predicate device, as presented in the comparative table. This relies on the established and accepted performance and safety profile of the predicate device.
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The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no training set.
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How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.