(40 days)
Liquichek Ethanol/Ammonia Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Liquichek Ethanol/Ammonia Control is prepared from bovine serum albumin with chemicals, stabilizers and preservatives added. This control is provided in liquid form for convenience.
The provided document is a 510(k) Premarket Notification for a Liquichek Ethanol/Ammonia Control, which is a quality control material used to monitor the precision of laboratory testing procedures. This is not a medical device that utilizes AI or machine learning, nor is it designed for diagnostic imaging or similar applications where the requested information (like MRMC studies, human reader improvement, or expert ground truth establishment) would be relevant.
Therefore, many of the requested categories about acceptance criteria and study design are not applicable to this type of product. The document describes a traditional medical device (a control solution) that undergoes stability testing, not a device that involves complex algorithms or human interpretation of outputs.
Here's a breakdown of the applicable information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" in the format typically seen for diagnostic devices (e.g., sensitivity, specificity thresholds). Instead, it describes "stability studies" performed to determine shelf-life and open-vial stability. The "reported device performance" is the claim of stability for these periods.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Stability of analyte levels within acceptable ranges over time. | Open Vial Stability: 20 days at 2 to 8°C on board Siemens Dimension Vista instrument |
| Shelf-life stability for the product. | Shelf Life Stability: 24 Months at 2 to 8°C |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of an algorithm or diagnostic evaluation. The stability studies likely involved multiple aliquots or batches of the control material over the specified periods.
- Sample Size: Not explicitly stated, but implies "replicate analyses" and "a representative sampling of this lot of product."
- Data Provenance: The studies were performed by the manufacturer (Bio-Rad Laboratories) and/or independent laboratories. No country of origin for the data is specified, but the manufacturer is based in Irvine, California, USA. The studies are prospective in nature, as they are establishing future stability claims.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This concept is not applicable to a quality control material. Ground truth in this context would refer to the true concentration of ethanol and ammonia, which is established by precise laboratory methods and analytical chemistry, not by human expert interpretation. The "value assignment" section states that mean values and ±3SD ranges were "derived from replicate analyses" by the manufacturer and independent laboratories.
4. Adjudication Method for the Test Set
This is not applicable. The "test set" in this context refers to samples used for analytical stability studies, not for the evaluation of a diagnostic algorithm's output that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. This type of study is designed for diagnostic devices that are interpreted by human readers, often with AI assistance. The Liquichek Ethanol/Ammonia Control is a quality control solution for laboratory instruments, not a device that human readers interact with in this manner.
6. Standalone Performance Study
This is not applicable in the sense of an algorithm operating independently. The "performance" of this device is its ability to maintain stable concentrations of ethanol and ammonia over time, which is assessed through laboratory testing of the control material itself (standalone in that sense, but not for an algorithm).
7. Type of Ground Truth Used
The ground truth for this device (the true values of Ethanol and Ammonia) is established through analytical testing and measurement using laboratory instruments specified in the value assignment section. It's based on precise chemical analysis, not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
This is not applicable. There is no "training set" as this device is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable.
§ 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.