(52 days)
The Quantimetrix GlycoHemosure is intended for the quality control of laboratory procedures for the quantitation of HbA1c.
The Quantimetrix GlycoHemosure is supplied liquid in glass bottles. It consists of humansource blood that was treated to give a stable liquid formulation of two distinct levels of HbA1c.
The provided text describes a 510(k) summary for the Quantimetrix GlycoHemosure, a quality control material for HbA1c quantitation. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for a medical device that makes diagnostic claims (e.g., sensitivity, specificity, accuracy).
Instead, the documentation focuses on the stability of the control material, which is a key performance characteristic for a quality control device.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Text) | Reported Device Performance |
|---|---|
| Shelf Life (2-8°C): Control material must maintain stability for a specified period. | At least 18 months shelf life (2-8°C). |
| Opened Vial Stability: Control material must maintain stability for a specified period after opening. | At least 30 days opened vial stability. |
Note: The text explicitly mentions "stability studies" were performed to "validate the shelf life claim and the opened vial claim." This implies that the acceptance criteria for these claims would be met if the control material remained within acceptable analytical ranges over these timeframes. However, the specific numerical acceptance limits (e.g., ±X% variation from initial value) are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The text states "Accelerated stability studies (25°C and 37°C) and real time studies (2-8°C) were performed."
- Sample Size: Not specified. This typically refers to the number of vials or batches tested.
- Data Provenance: Not specified, but implies internal testing by Quantimetrix Corporation. It is prospective testing for stability.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a control material, not a diagnostic device that requires expert interpretation for its "ground truth." Its performance relates to its internal stability and consistency over time, measured against a reference method.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication for the performance of a quality control material in this context. The "truth" for its stability is determined by analytical measurements against a defined reference.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is not relevant for a quality control material. MRMC studies are designed for diagnostic devices where human readers interpret results, and the study assesses how the device aids human performance.
6. Standalone Performance
Yes, implicitly. The stability studies evaluate the performance of the GlycoHemosure control material itself, without human interpretation or intervention beyond conducting the analytical measurements. The device's "performance" here is its inherent stability over time when measured using a standard HbA1c immunoassay.
7. Type of Ground Truth Used
The ground truth for the GlycoHemosure's stability is established by analytical measurement against a reference method or baseline value. The initial HbA1c concentration of the control material was determined using an immunoassay method (e.g., Dade HbA1c assay), and stability is assessed by comparing subsequent measurements to this initial value (or a derived reference) over time under different conditions.
8. Sample Size for the Training Set
Not applicable. Quality control materials fundamentally operate differently from AI/ML algorithms which require training sets. The GlycoHemosure is a prepared biological material with known concentrations, not an algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device. The quality control material itself serves as a "known" for laboratories to check the performance of their own HbA1c assays. Its own characteristics (concentration, stability) are established through analytical testing and manufacturing specifications.
§ 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.