(33 days)
nRBC-Chex for ADVIA® is an assayed whole blood control designed to evaluate the accuracy and precision of the Siemens Healthcare Diagnostics Inc. hematology analyzers in the measurement of the nucleated red blood cell parameter. Refer to product assay sheet.
nRBC-Chex for ADVIA® is stabilized suspension of human and animal blood, in a solution containing biological salts and anti-microbial preservatives. The product is packaged in plastic vials containing 4ml. The closures are polypropylene screw caps with polyethylene liners. There are two different levels. Level 1 has a low count and Level 2 has a higher count. The vials will be packaged in a two (2) or twelve (12) welled vacuum formed "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 - 10°C.
The provided text describes a 510(k) summary for the device "nRBC-Chex for ADVIA®," an assayed hematology control. It details the device's intended use, comparison to a predicate device, and the studies conducted to establish its performance.
Here's an analysis of the acceptance criteria and study information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the "Conclusions Drawn From Tests," and the reported performance is from the "Discussion of Tests and Test Results." Since specific numerical criteria (e.g., "± 5% reproducibility") are not explicitly stated, the acceptance is inferred from the affirmative statements about the device's performance meeting claims.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Closed Vial Stability: Device maintains performance for 45 days. | "nRBC-Chex for ADVIA® meets the claim of a 45 day closed vial stability." and "It meets the claim of a 45 day closed vial... stability." |
| Open Vial Stability: Device maintains performance for 14 days. | "It meets the claim of ... a 14 day open vial stability." |
| Run-to-Run Reproducibility: Device is consistently reproducible. | "All testing showed that nRBC-Chex for ADVIA® is consistently reproducible..." and "Reproducibility studies and Closed Vial Stability results confirm lot-to-lot consistency in the manufacture of nRBC-Chex for ADVIA®." |
| Site-to-Site Recovery of Values: Demonstrates consistent recovery across different sites. | "All testing showed that nRBC-Chex for ADVIA® is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed." (Direct performance for "Site to Site recovery of values" is not explicitly detailed but is covered under the general statement of "All testing showed that nRBC-Chex for ADVIA® is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed.") |
| Substantial Equivalence: Device is substantially equivalent to the predicate. | "All testing showed that nRBC-Chex for ADVIA® is ... substantially equivalent to the predicate product..." |
| Effectiveness as QC Material: Effective for evaluating accuracy and precision on specified analyzers. | "nRBC-Chex for ADVIA® is an effective quality control material for evaluating the accuracy and precision of the Siemens Healthcare Diagnostics Inc. ADVIA® 2120 in its measurement of the nucleated red blood cell parameter." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data). The studies mentioned (Closed Vial Stability, Open Vial Stability, Run to Run Reproducibility, Site to Site recovery of values) would typically involve multiple runs and vials, but the specific numbers are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this device is an assayed hematology control, "ground truth" is established through measurements by calibrated analytical instruments, rather than human expert opinion. The document does not mention the involvement of human experts for establishing ground truth for the performance studies.
4. Adjudication Method for the Test Set
Not applicable. As a quality control material, the performance is assessed against established measurement principles and instrumental accuracy, not through human adjudication of diagnostic outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or interpretation devices where human readers are involved. This device is a quality control material for automated hematology analyzers, so expert interpretation of cases is not relevant.
6. If a Standalone Study Was Done
Yes, the described studies (Closed Vial Stability, Open Vial Stability, Run to Run Reproducibility, and Site to Site recovery of values) represent standalone performance evaluations of the nRBC-Chex for ADVIA® device itself, in conjunction with the specified hematology analyzers. The goal was to demonstrate its intrinsic performance as a control material. There is no mention of human-in-the-loop performance being evaluated.
7. The Type of Ground Truth Used
The ground truth for evaluating the performance of "nRBC-Chex for ADVIA®" would be based on instrumental measurements and reference methods. As an assayed hematology control, its values are established by careful measurement on reference analyzers or by comparing to reference materials, ensuring accuracy and precision. The document states it's "designed to evaluate the accuracy and precision" of hematology analyzers, implying its own values are established precisely.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. This device is a consumable quality control material, and its development would involve formulation and testing, not a machine learning training phase.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of device development described here. The ground truth for the assayed values of the control material itself would be established through extensive laboratory testing, calibration, and validation using reference methods and highly accurate analyzers.
§ 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.