(51 days)
e-CHECK (XE)™ is intended to be used as a control for complete blood cell count (CBC), white blood cell differential, reticulocyte and nucleated red blood cell (NRBC) parameters on Sysmex XE - series instruments.
e-CHECK (XE) is a suspension of stabilized human and animal blood packaged in dlass vials, containing 4.6 mL volumes. Closures are injection molded polypropylene screw top caps. The device will consist of three levels: Low CBC/High Retic (Low Level), Normal CBC/Intermediate Retic (Normal Level), and High CBC/Low Retic (High Level).The vials are packaged in a welled vacuum formed clam-shell container with the package insert and assav sheet.
Here's an analysis of the provided text regarding the e-CHECK (XE)™ device, structured according to your requested information.
It's important to note that the provided 510(k) summary is for a hematology control mixture, not an AI-powered diagnostic device. Therefore, many of the typical acceptance criteria and study methodologies you'd expect for an AI device (like sensitivity, specificity, human reader improvement for MRMC studies, or ground truth established by expert consensus on images) are not applicable here. The focus for this control device is on its stability and reproducibility in mimicking human blood parameters for calibration and quality control of laboratory instruments.
Device: e-CHECK (XE)™ (Assayed hematology control)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Lot to Lot Reproducibility (consistent performance across manufacturing batches) | Study results showed e-CHECK (XE) to be consistently reproducible |
| Long Term Stability (performance over the product's shelf life) | Study results showed e-CHECK (XE) to be stable for the entire product dating |
| Open Vial Stability (performance after opening the vial for use) | Study results showed e-CHECK (XE) to be stable. |
| Substantial Equivalence to Predicate Device (e-CHECK) | Study results showed e-CHECK (XE) to be substantially equivalent to the predicate products |
| Fulfillment of Intended Use (control for CBC, WBC diff, reticulocyte, NRBC parameters on Sysmex XE-series) | e-CHECK (XE) is a safe and effective product, which fulfills its intended use when used as instructed in the product package insert. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not explicitly state the sample sizes used for the studies (Lot to Lot Reproducibility, Long Term Stability, and Open Vial Stability). It also does not specify the data provenance in terms of country of origin or whether it was retrospective or prospective, though general "study results" are mentioned, implying prospective testing of manufactured lots.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable or provided in the context of this device. For a hematology control mixture, the "ground truth" is typically established by certified laboratory reference methods and the specific parameters measured on the Sysmex XE-series instruments. It's not about expert interpretation of complex data like medical images.
4. Adjudication Method for the Test Set
This information is not applicable or provided. Adjudication methods like 2+1 or 3+1 are used for expert consensus on subjective assessments, which is not relevant for a hematology control.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not done. This is a hematology control device, not an AI-powered diagnostic tool, so reader performance improvement with AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical control substance, not an algorithm. Its performance is measured directly by laboratory instruments when the control is run.
7. The Type of Ground Truth Used
The "ground truth" for this type of device is implicitly based on:
- Reference Methods: The established values for CBC, white blood cell differential, reticulocyte, and NRBC parameters on the relevant Sysmex XE-series instruments, determined through highly accurate and calibrated laboratory methods.
- Predicate Device Performance: Performance data from the existing e-CHECK predicate device serves as a baseline for substantial equivalence.
- Stability Definitions: Defined limits for acceptable variation over time and under different handling conditions.
8. The Sample Size for the Training Set
This information is not applicable or provided. The concept of a "training set" applies to machine learning algorithms. This device is a manufactured biological control.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided. As mentioned above, there's no "training set" in the context of this device. The development of such a control material involves formulation, stabilization, and then extensive testing to characterize its properties against established laboratory standards to ensure it consistently delivers expected values on the target instruments.
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.