(29 days)
nRBC-Chex for LH is an assayed whole blood control designed to evaluate the accuracy and precision of the Beckman Coulter® LH 750 in its measurement of the nucleated red blood cell parameter.
nRBC-Chex for LH 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 six (6) or twelve (12) welled vacuum formed "clam-shell" container with the package in a sk (v) product must be stored at 2 - 10°C.
The provided text describes a medical device called "nRBC-Chex for LH," which is an assayed whole blood control. The document focuses on establishing the substantial equivalence of this device to a predicate device for its intended use, rather than detailing specific acceptance criteria for a novel diagnostic algorithm's performance in a clinical study.
Therefore, many of the requested sections about acceptance criteria, sample sizes for test sets, expert involvement, and ground truth establishment, which typically apply to studies evaluating the performance of a diagnostic device (like an AI algorithm), are not directly applicable or explicitly stated in this 510(k) summary for a quality control material.
However, I can extract information related to the studies conducted to establish the performance and stability of the nRBC-Chex for LH control material.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of acceptance criteria in the way one would for a diagnostic test's sensitivity/specificity. Instead, it describes general claims and confirms stability and reproducibility.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Consistency/Reproducibility | "All testing showed that nRBC-Chex for LH is consistently reproducible..." |
| "Reproducibility studies and Closed Vial Stability results confirm lot-to-lot consistency in the manufacture of nRBC-Chex for LH." | |
| Stability (Closed Vial) | "meets the claim of a 75 day closed vial" (Note: Product description states 7 days, summary states 75 days, this is a discrepancy in the provided text. I will use the summary's claim for this table.) |
| "All testing showed... stable for the shelf life claimed." | |
| Stability (Open Vial) | "meets the claim of ... a 14 day open vial stability" |
| Substantial Equivalence to Predicate | "All testing showed that nRBC-Chex for LH is ... substantially equivalent to the predicate product" |
| Effectiveness as QC Material | "nRBC-Chex for LH is an effective quality control material for evaluating the accuracy and precision of the Beckman Coulter LH 750 in its measurement of the rucleated red blood cell parameter." |
2. Sample size used for the test set and the data provenance:
- Test Set Size: Not explicitly stated. The document mentions "Four types of studies were conducted," but details on the number of samples, runs, or lots used in each study (Closed Vial Stability, Open Vial Stability, Run to Run Reproducibility, and Site to Site recovery of values) are not provided.
- Data Provenance: Not specified. There is no mention of the country of origin or whether the studies were retrospective or prospective. Given the nature of a quality control material, the studies would likely be prospective laboratory experiments conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the device is a control material, not a diagnostic device requiring expert interpretation of clinical data for ground truth establishment. The "ground truth" for a control material would be its manufactured, assayed values, determined by standardized laboratory methods, not by expert consensus on clinical cases.
4. Adjudication method for the test set:
- Not applicable. This device is a control material, and its performance is evaluated against defined parameters, not through adjudication of clinical cases.
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 diagnostic device, nor does it involve human readers interpreting cases. It is a quality control material for a hematology analyzer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical control material, not an algorithm. Its "standalone" performance refers to its intrinsic stability and reproducibility when measured by the target instrument (Beckman Coulter LH 750). The studies conducted (Closed Vial Stability, Open Vial Stability, Run to Run Reproducibility, and Site to Site recovery of values) can be considered evaluations of its standalone performance as a control material.
7. The type of ground truth used:
- For a control material like nRBC-Chex for LH, the "ground truth" refers to the assigned target values for the nucleated red blood cell parameter. These values would be established during the manufacturing and assaying process, typically through highly precise and accurate reference methods. The document doesn't explicitly detail how these specific target values are established but implies they are part of the "assayed" nature of the control.
8. The sample size for the training set:
- Not applicable. This is a physical control material, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set is involved.
§ 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.