(37 days)
HemoCue HemoTrol control is compared to the HemoCue Whole Blood Control, manufactured for HemoCue by Streck Laboratories, Inc., 14306 Industrial Road, Omaha, Nebraska, 68144. Product descriptions, intended use and assay values for this product are included for comparison.
These two products are similar in matrix, chemical composition, technological characteristics, intended use, and packaging specifications.
This document describes a 510(k) submission for the HemoCue HemoTrol control solution. It focuses on demonstrating substantial equivalence to an existing device, not on the performance of a diagnostic device that detects a disease or condition. Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable.
However, I can extract and interpret the available information in the context of demonstrating substantial equivalence for a control solution.
Here's an adaptation of your requested format based on the provided text:
Acceptance Criteria and Study for HemoCue HemoTrol Control Solution
The objective of the studies described is to demonstrate "substantial equivalence" of the HemoCue HemoTrol control solution to the predicate device, HemoCue Whole Blood Control (manufactured by Streck Laboratories). The acceptance criteria are implicitly related to the predicate device's performance and established norms for control solutions (e.g., stability, precision, compatibility).
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a control solution and the provided text, the "acceptance criteria" are implied by the comparison to the predicate device. The performance is reported in terms of demonstrating comparability rather than meeting specific clinical thresholds for diagnosing a condition.
| Acceptance Criteria (Implied) | Reported Device Performance (HemoCue HemoTrol) |
|---|---|
| Shelf Life Stability: Maintain intended assay values over time under specified storage conditions. | Six shelf life validation time studies conducted at 2-8℃ and/or 25℃, over periods ranging from 0 to 876 days (approximately 2.4 years), incorporating a variety of production lots. |
| (Performance indicates successful stability for these durations.) | |
| Open Vial Stability: Maintain intended assay values after opening for specified periods and temperatures. | Open vial stability studies conducted at room temperature and 2-8℃. |
| (Performance indicates satisfactory open vial stability under these conditions.) | |
| Compatibility and Non-interference: Function correctly with the intended analyzer without interference. | Compatibility and non-interference studies with the "intended analyzer" (HemoCue B-Hemoglobin analyzers). |
| (Performance indicates compatibility and no interference.) | |
| Precision: Demonstrate comparable precision to the predicate device. | A precision study compared HemoCue HemoTrol to HemoCue Whole Blood Control (Streck) at three (3) levels, measured on three (3) different HemoCue B-Hemoglobin analyzers, in replicates of 10. |
| (Performance indicated "comparable precision" to the predicate device.) | |
| Accuracy: Demonstrate comparable accuracy to the predicate device. | Not explicitly detailed as a separate study with specific results, but "comparable precision and accuracy" is stated as an overall outcome when compared to the Streck product. |
| (Performance indicated "comparable accuracy" to the predicate device, likely derived from the precision study and comparison to established values.) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set:
- Shelf Life Studies: "a variety of production lots" were used over periods ranging from 0 to 876 days. The exact number of lots or individual units within each lot is not specified.
- Precision Study: Three (3) levels of HemoTrol were tested, and each level was subjected to "replicates of 10" measurements. This implies a total of 30 measurements per analyzer type for HemoTrol (3 levels x 10 replicates). The same would apply to the predicate device for comparison. The study was conducted on three (3) different HemoCue B-Hemoglobin analyzers.
- Data Provenance: The document implies the studies were conducted by HemoCue or their contractors. The predicate device's manufacturer (Streck Laboratories, Inc.) is located in Omaha, Nebraska, USA. The data provenance (country of origin) for the studies themselves is not explicitly stated but would likely be where HemoCue (originating from Sweden) or its US operations conducted the testing. The data is prospective in nature, as these are controlled laboratory tests conducted to evaluate the product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable to a control solution's substantial equivalence submission. "Ground truth" in this context would generally refer to the established assay values for the control solution, which are determined by the manufacturer through precise analytical methods, not by expert consensus in the typical sense of clinical image interpretation or diagnosis. The predicate device's assay values serve as the comparative ground for demonstrating equivalence.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1) are typically used in clinical studies where human interpretation of medical images or patient data is involved to resolve discrepancies. For analytical performance studies of a control solution, the results are quantitative measurements, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. MRMC studies are relevant for evaluating diagnostic devices where human readers interpret medical cases. This submission is for a control solution, which is used to verify the performance of an analytical instrument, not a diagnostic device interpreted by human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not directly applicable. The "device" in this submission is a chemical control solution, not an algorithm or an AI system. The performance evaluated is that of the control solution itself when measured by an analytical instrument (HemoCue B-Hemoglobin analyzers), which operates without human interpretation in the measurement process. The studies focused on the performance of the material (HemoTrol) itself, such as its stability and its ability to produce consistent, comparable results on the analyzers.
7. The Type of Ground Truth Used
The "ground truth" for these studies is the established analytical values or expected performance characteristics of both the HemoCue HemoTrol and its predicate device, HemoCue Whole Blood Control (manufactured by Streck Laboratories).
- For shelf-life and open-vial stability, the ground truth is the expected stability profile and maintenance of established assay values over time.
- For precision, the ground truth is the inherent variability and reproducibility of the measurements, compared to the known precision of the predicate device.
- For accuracy, the ground truth is the proximity of the HemoTrol's measured values to its established target values and consistency with the predicate device's established values.
This is based on analytical laboratory data and pre-defined specifications, not expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The HemoCue HemoTrol is a chemical control solution.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as 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.