(187 days)
Body Fluid Control is a hematology quality control material used to monitor the performance and verify the measuring range of the body fluid cycle of the UniCel® DxH 800 COULTER Cellular Analysis System. Refer to the System HELP or Instructions for Use.
The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor performance, and verify the measurable range. This product can also be used to establish your own laboratory mean.
Body Fluid Control is a reference product prepared from treated, stabilized human erythrocytes suspended in an isotonic medium. Body Fluid Control also contains a stabilized, platelet-sized component, and fixed erythrocytes to simulate leukocytes. Body Fluid Control confirms and monitors instrument accuracy and precision performance by providing measurements during counting.
This submission (K082162) is for the COULTER® Body Fluid Control, a hematology quality control material. It is a control product, not a diagnostic device that performs measurements on patient samples with an AI component. Therefore, the typical acceptance criteria and study designs involving AI-driven performance metrics, ground truth establishment, and expert adjudication are not applicable here.
Instead, the "performance" of this device relates to its stability and its ability to consistently monitor the accuracy and precision of instruments like the UniCel® DxH 800 COULTER Cellular Analysis System. The study mentioned focuses on the control material's stability, not its diagnostic accuracy in identifying medical conditions.
Here's an breakdown of the provided information in the context of a quality control device:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" in the way a diagnostic device might have performance thresholds (e.g., sensitivity, specificity). For a quality control material, acceptance is based on its stability and its ability to provide consistent "assigned values and expected ranges" for monitoring an instrument's performance.
| Acceptance Criteria (Implied for a QC Material) | Reported Device Performance (from text) |
|---|---|
| Stability (Closed Vial) | 120 days |
| Stability (Open Vial) | 16 days (for 18 events) |
| Ability to monitor instrument accuracy and precision. | "Body Fluid Control confirms and monitors instrument accuracy and precision performance by providing measurements during counting." |
| Ability to verify measuring range. | "The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor performance, and verify the measurable range." |
| Substantial Equivalence to Predicate | Found substantially equivalent to COULTER® 5C® Cell Control (Cleared as COULTER® PX Cell Control) (K912133 & K060464). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Stability studies of Body Fluid Control." It does not specify the sample size used for these studies, nor the country of origin, or if they were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. For a quality control material, the "ground truth" would be established by reference methods or manufacturing specifications to determine the assigned values and expected ranges for the control. The document does not detail this process but implies that "assigned values and expected ranges on the TABLE OF EXPECTED RESULTS" are provided with the product.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device is not an AI algorithm requiring adjudication of its output.
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 a diagnostic device or an AI assistant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for a quality control material like this would be the reference values and expected ranges established during its manufacturing and characterization process. These values are determined through rigorous testing with calibrated instruments and established methodologies to ensure the control material is stable and provides consistent results within specified analytical ranges. The document states, "The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor performance, and verify the measurable range."
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of 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.