(17 days)
This product is intended for in vitro diagnostic use as a control product to assess the analytical performance of clinical chemistry systems using methods for the quantitative measurement of ammonia, ethanol, and lactate. It is intended to provide the necessary control material required by inspection agencies for the evaluation of system performance. In addition, it will provide assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies.
DOCUMENT Ammonia, Ethanol, Lactate Assayed Controls consist of three levels of an aqueous matrix containing ammonia, ethanol, and lactate. The formulation design provides a liquid matrix intended for use on automated, semi-automated, and manual clinical chemistry systems for the determination of ammonia (AMM), ethanol (ALC), and lactate (LAC).
The provided 510(k) summary describes the "DOCUMENT® Ammonia, Ethanol, Lactate Assayed Control" and its comparison to predicate devices, but it does not contain the level of detail requested for acceptance criteria and a study demonstrating device performance as would be expected for an AI/ML medical device.
This document is for an assayed control product, which is a material used to check the accuracy and precision of laboratory tests, not a diagnostic device that performs an analysis on patient samples. Therefore, many of the requested elements (like sample size for test sets, ground truth by experts, MRMC studies, standalone performance of an algorithm) are not applicable to this type of device.
However, I can extract the relevant information and indicate where details are missing or not applicable.
Acceptance Criteria and Study for DOCUMENT® Ammonia, Ethanol, Lactate Assayed Control
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | To assess analytical performance of clinical chemistry systems for ammonia, ethanol, and lactate; provide control material for inspection agencies; aid troubleshooting. | The product's characteristics are aligned with this intended use, providing an assayed control for the specified analytes. |
| Comparison to Predicate Devices | Behaves in a similar manner to predicate devices for assessing analytical performance. | "The results show that the DOCUMENT® Ammonia, Ethanol, Lactate Assayed Control behaves in a similar manner compared to the predicate devices..." |
| Inter-assay Precision (for analytes: Ammonia, Ethanol, Lactate) | Similar inter-assay precision to the predicate CASCO DOCUMENT® Ammonia/Ethanol (Protein-Based) Controls and Bio-Rad Liquichek Unassayed Chemistry Controls. | "...comparing the inter-assay precision... to that of CASCO DOCUMENT® Ammonia/Ethanol (Protein-Based) Controls and Bio-Rad Liquichek Unassayed Chemistry Controls." The document states this comparison demonstrated similar behavior. |
| Suitability for Use | Suitable for use as a control for ammonia, ethanol, and lactate. | "...and is suitable for use as a control for the listed analytes." |
| Product Specifications (e.g., Number of Levels, Type, Analytes, Volume, Matrix, Storage, Stability, Container) | Match or are equivalent to the described specifications (e.g., 3 levels, assayed, 3 analytes, 4mL aqueous, 2-8°C storage, 30 days open stability). | All specifications listed in the "Comparison to the Predicate Device" table are presented as the device's characteristics. |
Note: The document explicitly states "The equivalence for this product was carried out by comparing the inter-assay precision" and that the results demonstrated "similar manner" and "suitable for use." However, specific numerical acceptance criteria (e.g., "precision must be within X% of predicate") and the raw performance data (e.g., actual precision values) are not provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The study compared the new control product against predicate devices by assessing inter-assay precision, but the number of runs or samples used to determine this precision is not stated.
- Data Provenance: Not specified. It can be inferred that the testing was conducted internally by CASCO Standards as part of their product development and validation process. The country of origin is implicitly the USA (Yarmouth, ME), and the study would be considered prospective for the development of this specific control material.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is an assayed control product, not a diagnostic device that interprets patient data. The "ground truth" for a control material typically comes from the manufacturing process and metrological traceability, not expert interpretation of results. The stated analytes (ammonia, ethanol, lactate) are precisely measured chemical components.
4. Adjudication method for the test set
- Not Applicable. See point 3.
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 not an AI/ML diagnostic device, nor does it involve human readers or interpretation of complex cases. It's a quality control material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm.
7. The type of ground truth used
- For a control product, the "ground truth" for the declared values of ammonia, ethanol, and lactate would be established through a rigorous analytical chemistry process, typically using highly accurate reference methods and potentially traceable reference materials. The summary does not detail the exact methodology for assigning the assayed values to the control material, but it's fundamentally based on quantitative chemical analysis, not expert consensus or pathology in a diagnostic sense.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set. The control material is manufactured and characterized.
9. 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.