(14 days)
R&D BODY FLUID Control is used to monitor total cell counts performed manually using a hemocytometer to validate the quantitation of red and white cells in patient body fluid samples.
This control is an assay control mixture for hemocytometer counts. R&D BODY FLUID Control is composed of WBCs and RBCs in a stabilizing medium. R&D BODY FLUID Control simulates cells and body fluids in morphology and count.
The provided text describes the 510(k) summary for the R&D Systems, Inc. BODY FLUID Control device. This device is a quality control mixture for hemocytometer counts, simulating cells and body fluids in morphology and count.
Here's an analysis of the acceptance criteria and study information provided:
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 BODY FLUID Control passed the acceptance criteria of remaining within the assay range over the life of the product." |
| Demonstrated precision. | "R&D BODY FLUID Control has demonstrated precision as indicated by the small standard deviation and %CV's obtained during laboratory testing." |
| Expiration dating established. | "Expiration dating has been established at 14 weeks in customers hands (closed vial) and 30 days, or 14 entries (open vial) when stored at 2 - 8° C and handled according to instructions for use." |
| Substantial equivalence in performance, precision, and stability to the predicate device (Spinalscopics Control). | "Laboratory testing of 3 validation lots have shown R&D BODY FLUID Control to have substantial equivalence in performance, precision and stability to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Laboratory testing of 3 validation lots" were used for the study. The specific number of individual samples or measurements within each lot is not specified.
- Data Provenance: The study was conducted through "laboratory testing," implying an internal validation study. The country of origin and whether the data was retrospective or prospective are not explicitly stated. However, given it's a 510(k) submission from a US-based company (Minneapolis, MN), it's highly likely to be prospective laboratory testing conducted in the US.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable / not provided for this device. The device is a quality control material, not a diagnostic device that interprets patient data. Its "ground truth" or reference values are inherent to the controlled composition of the product, verified through laboratory testing against established methods, rather than expert interpretation of images or patient cases.
4. Adjudication Method for the Test Set
This information is not applicable / not provided. As mentioned above, the study focuses on the performance characteristics of a quality control product, not on interpreting patient results where adjudication by experts might be needed for ground truth establishment. The performance is assessed against predefined assay ranges and comparison to a predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done.
- Effect Size: Not applicable, as no such study was conducted. This type of study is relevant for diagnostic devices where human readers interpret cases with and without AI assistance. This device is a quality control material.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, in spirit, a standalone performance was done. The device itself is a control material, and its performance (precision, stability, assay range adherence) was evaluated independently. There isn't an "algorithm" in the typical sense for an AI device, but the performance of the control material (analogous to the "algorithm" in terms of its function) was assessed directly. The intended use is to "monitor total cell counts performed manually using a hemocytometer," so the control itself doesn't involve an automated human-in-the-loop scenario, but rather provides a standard for a manual process.
7. Type of Ground Truth Used
The "ground truth" for this control device is its predefined target values and established assay ranges, determined during its development and manufacturing, and validated through laboratory testing. The study verified that the device remained within these expected ranges and demonstrated precision, and confirmed its "substantial equivalence" to the established performance of the predicate device.
8. Sample Size for the Training Set
This information is not applicable / not provided. This device is a quality control material, not an AI or machine learning algorithm that requires a "training set" in the traditional sense. Its formulation and performance characteristics are established through chemical and biological manufacturing processes and analytical testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable / not provided. As above, there is no "training set" for this type of device. The "ground truth" for the control's performance is established through manufacturing specifications, analytical methods, and comparison to an existing commercially available predicate device.
§ 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.