(22 days)
R&D LH-nRBC Hematology Control is a tri-level control for use in monitoring the performance of Coulter® hematology instruments and other auxiliary methods. Refer to assay sheet for specific instrument models.
This control is a tri-level control for use in monitoring the performance of Coulter® hematology instruments and other auxiliary methods.
Here's an analysis of the provided text regarding the R&D LH-nRBC Hematology Control, formatted to address your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remaining within the assay range over the life of the product. | "R&D LH-nRBC Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product." |
| Precision (indicated by standard deviation and % CV's) | "R&D LH-nRBC Hematology Control has demonstrated precision as indicated by the small standard deviation and % CV's obtained during laboratory testing." |
| Closed Vial Stability | "Expiriation dating has been established at 75 days (closed vial) when stored at 2 - 8° C and handled according to instructons for use." |
| Open Vial Stability | "Expiriation dating has been established at... 14 days (open vial) when stored at 2 - 8° C and handled according to instructons for use." |
| Substantial Equivalence to Predicate Device | "Laboratory testing of 3 validation lots has shown R&D LH-nRBC Hematology Control to have substantial equavalence in performance, precision and stability to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Laboratory testing of 3 validation lots." However, it does not explicitly state the specific sample size (e.g., number of test runs, number of instruments, or number of individual control vials/measurements) for each lot.
The data provenance is not explicitly stated in terms of country of origin. The study was conducted by R&D Systems, Inc., which is located in Minneapolis, MN, USA. The nature of the study (retrospective or prospective) is not specified, but the description of "laboratory testing of 3 validation lots" suggests a controlled, prospective study designed for validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for this type of device (a quality control mixture) is typically established by the inherent properties of the control material and its performance on standardized instruments, rather than human expert interpretation.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. Adjudication methods are typically used when human interpretation is involved in establishing ground truth, such as in image analysis or clinical diagnosis studies. For a hematology control, "acceptance criteria" are quantitative and directly measured by instruments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results, where the goal is to assess how a device affects human reader performance. This device is a quality control material for instruments, not a diagnostic device for human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in essence, a standalone performance assessment was done. The "device" in this context is the control mixture itself, which is designed to perform consistently on automated hematology instruments. The testing described focuses on the control's intrinsic performance (stability, precision, staying within assay range) when run on these instruments, without human interpretive input altering the results being assessed. The phrase "laboratory testing of 3 validation lots" and the reporting of "small standard deviation and % CV's" directly reflect the standalone performance of the control.
7. The Type of Ground Truth Used
The ground truth for this device is based on pre-defined assay ranges and established precision metrics for hematology instruments. The control is designed to produce expected values within these ranges and with acceptable precision. The "ground truth" is not derived from expert consensus, pathology, or outcomes data in the usual diagnostic sense, but rather from the known performance characteristics required for a reliable quality control product.
8. The Sample Size for the Training Set
This information is not provided and is largely not applicable in the conventional sense for this type of device. A quality control material like this does not typically have a "training set" in the way an AI algorithm would. Its formulation and expected performance are established through chemical and biological engineering, and then validated through testing. There might have been R&D formulation studies or preliminary testing, but these aren't described as a "training set" in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" and its associated ground truth is not explicitly applicable or described for this device. The "ground truth" for the control's design and intended performance would have been established through a combination of:
- Manufacturer specifications: The R&D team designing the control would define what constitutes "in range" and "precise" performance based on the requirements of the hematology instruments it's intended to monitor.
- Instrument manufacturer's specifications: The control is designed for "Coulter® hematology instruments," so the performance characteristics and acceptable variations of these instruments would inform the control's ground truth.
- Industry standards: General good manufacturing practices and standards for quality control materials for IVD devices would guide establishment of acceptable performance.
§ 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.