(44 days)
It is an established laboratory procedure to use a stable control to monitor the performance of diagnostic tests. HCT Extended Hematology Control is an assayed control designed to monitor values obtained from automated, semi-automated and manual methods. For in vitro Diagnostic Use Only
HCT Extended Hematology Control is an in vitro diagnostic reagent composed of human erythrocytes suspended in a plasma-like fluid with preservatives. It is an assayed whole blood control designed to monitor values obtained from automated, semi-automated and manual methods. It is sampled in the same manner as a patient specimen.
Here's an analysis of the provided text regarding the acceptance criteria and study for the HCT Extended Hematology Control:
Please note: The provided text is a 510(k) summary for a diagnostic test control (Hematology Quality Control Mixture), not an AI/ML powered device. Therefore, many of the typical acceptance criteria and study design elements found in AI/ML performance studies (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable or explicitly mentioned in detail in this type of submission. The focus for a control device is typically on demonstrating stability, precision, and equivalence to a predicate device.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Stability & Performance | Remaining within the assay range over the stated life of the product. | "The HCT Extended Hematology Control passed the acceptance criteria of remaining within the assay range over the stated life of the product." "substantial equivalence in performance, precision and stability to the predicate device." |
Study Details
-
Sample size used for the test set and the data provenance:
- Sample Size: The document states that "Laboratory testing of 3 validation lots" was performed. This refers to manufacturing lots of the control material, not a dataset of patient samples. The number of individual test runs or replicates within these lots is not specified.
- Data Provenance: Not explicitly stated, however, as a laboratory control, the testing would have been conducted internally by R&D Systems, Inc. The document does not refer to patient data from a specific country or whether it was retrospective or prospective in the context of typical AI/ML studies.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not stated. For a hematology control, "ground truth" is typically established by the manufacturer through precise analytical methods and quality control procedures, not by expert review of individual cases. The "assay range" is determined by the expected values on various instruments.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. This concept is not relevant for a quality control material where performance is assessed analytically against predefined ranges, not through subjective interpretation requiring adjudication.
-
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:
- No. This is not an AI/ML device and therefore no MRMC study was performed. The device is a diagnostic reagent (control), not an AI-assisted interpretation tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device. Its "performance" refers to its analytical characteristics (stability, precision) when tested in a laboratory setting using standard laboratory instruments.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Manufacturers' established assay ranges and analytical precision. The "ground truth" for a control device is its expected value range and stability, which is determined by the manufacturer based on analytical testing, calibration to reference methods (if applicable), and established quality control principles.
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device that requires a training set.
Summary Context:
This 510(k) pertains to a hematology quality control product. Its purpose is to ensure laboratory instruments are performing correctly by providing a known sample with expected assay ranges. The "study" described is a validation of the control's performance, precision, and stability against the manufacturer's established criteria and in comparison to a previously cleared predicate device. The core requirement for clearance is demonstrating "substantial equivalence" to the predicate, meaning it performs similarly and has the same intended use and technological characteristics. The provided text confirms that the device passed its internal acceptance criteria, primarily revolving around maintaining its assay range over its specified lifespan.
§ 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.