(16 days)
Elecsys CalCheck HCG is intended for use in the quantitative verification of the calibration curve established by the Elecsys HCG reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.
The Elecsys CalCheck HCG is a three level single analyte set of lyophilized, human based materials. After reconstitution they are assayed in triplicate and the results are compared to the target values.
This document describes a device for in vitro diagnostic (IVD) use, specifically a calibration verification material. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for regulatory purposes. It does not contain information about a clinical study evaluating the device's performance against acceptance criteria in the way one would describe for a diagnostic algorithm or imaging device.
Therefore, many of the requested categories are not applicable to the information provided.
Here's an analysis based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the conventional sense for a diagnostic device. This is a calibration verification material. The "performance" is its ability to verify a calibration curve, which is assessed during the manufacturing and validation of the product itself, not through a clinical study with patients. The 510(k) process for such devices focuses on demonstrating that the new device performs "as intended" and is substantially equivalent to a legally marketed predicate.
The summary states: "After reconstitution they are assayed in triplicate and the results are compared to the target values." This implies an internal quality control process to ensure the material meets its specifications, rather than external acceptance criteria from a clinical trial.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the 510(k) summary (likely internal specifications for target values and control limits) | The device is designed to be assayed in triplicate and compared to target values to verify calibration curves. The document asserts substantial equivalence, implying it meets performance comparable to the predicate. |
Non-Applicable Sections for this type of 510(k) Submission:
The following sections are related to clinical studies and algorithm performance, which are not present in this 510(k) summary for a calibration verification material:
2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" here in the context of a clinical study with patient data.
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 an IVD calibration material is established by highly controlled analytical methods and target value assignments during manufacturing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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-powered diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the clinical sense. The "ground truth" for a calibration verification material refers to its assigned target values, which are determined through rigorous analytical and manufacturing processes, traceable to reference methods where applicable.
8. The sample size for the training set: Not applicable. This is not an AI/algorithm-driven device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.
Summary of Relevant Information from the Provided Text:
- Intended Use: Elecsys CalCheck HCG is intended for use in the quantitative verification of the calibration curve established by the Elecsys HCG reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.
- Device Description: A three-level, single-analyte set of lyophilized, human-based materials. After reconstitution, they are assayed in triplicate, and results are compared to target values.
- Predicate Device: Tosoh Medic AIA-Pack HCG Calibration Verification Test Set, K924862.
- Substantial Equivalence: The submission claims substantial equivalence to the predicate device, emphasizing that the intended use is the same: to verify the calibration curve for their labeled analytes on automated immunoassay analyzers.
In essence, this 510(k) summary is for a quality control material used to assess the performance of other diagnostic devices (immunoassay analyzers), not a diagnostic device itself that would typically undergo the kind of clinical performance study described in your template.
§ 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.