(62 days)
The Audit™ MicroCV™ Procalcitonin Linearity Set is assayed quality control material consisting of five levels of Procalcitonin analyte in bovine serum albumin. The five levels demonstrate a linear relationship to each other for the Procalcitonin analyte. It is intended to simulate human patient serum samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for Procalcitonin. This product may be used as an assayed quality control material for Procalcitonin analyte.
The Audit™ MicroCV™ Procalcitonin Linearity Set is a bovine serum albumin, freeze dried, five level set of QC material, with each level containing one analyte: Procalcitonin. It is used to confirm the proper calibration, linear operating range, and reportable range of Procalcitonin. Level A has concentration near the lower limit level and Level E has concentrations near the upper limit level of instruments. Levels B – D are related by linear dilution of Level A and Level E.
The provided document describes a 510(k) summary for the Audit™ MicroCV™ Procalcitonin Linearity Set, a quality control material. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria for a new clinical diagnostic device. Therefore, much of the requested information regarding clinical studies, sample sizes, expert ground truth, and comparative effectiveness is not applicable or available in this specific document.
However, based on the information provided, here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) like a diagnostic device would. Instead, the "performance" here relates to the stability of the QC material, and the acceptance is based on demonstrating substantial equivalence to a predicate device for its intended use.
| Acceptance Criterion (Implicit based on product claims) | Reported Device Performance (Summary) |
|---|---|
| Open Vial Stability | Procalcitonin analyte is stable for 5 days when stored tightly capped at 2-8°C. |
| Shelf Life | One year at 2-8°C. (Real-time studies ongoing) |
| Linear Relationship | The five levels of Procalcitonin demonstrate a linear relationship to each other. |
| Substantial Equivalence to Predicate | Determined to be substantially equivalent to K042318 based on technical characteristics, intended use, and stability data. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of clinical performance evaluation using patient samples. The device is a quality control material. The stability studies carried out would involve batches of the QC material.
- Sample Size: Not specified in terms of clinical samples. Stability studies would have used multiple units/batches of the QC material.
- Data Provenance: Not explicitly stated as "country of origin" for clinical data. The studies were performed internally by Aalto Scientific, Ltd. (Carlsbad, CA, USA). The studies are "real-time studies," which indicates a prospective data collection for stability.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As this is a quality control material, the "ground truth" for its performance relates to its chemical stability and linearity, which are evaluated through laboratory-based analytical methods rather than expert clinical consensus.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" requiring clinical adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a quality control material, not a diagnostic device requiring MRMC studies for human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a laboratory reagent, not an algorithm.
7. The Type of Ground Truth Used
For the stability and linearity claims:
- Ground Truth: Laboratory analytical measurements (e.g., spectrophotometry, immunoassay to quantify Procalcitonin concentrations) performed on the QC material over time and across different dilutions. These measurements are typically compared against established analytical standards and internal specifications to confirm stability and linearity.
8. The Sample Size for the Training Set
Not applicable. This device is a quality control material and does not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
§ 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.