(51 days)
iQ® Body Fluids Controls are intended for use on iQ® Series analyzers, with the optional iQ® Body Fluids Module installed, as a control for evaluating body fluid RBC and nucleated cell counts. The device will consist of two levels of red blood cells and nucleated cells.
iQ Body Fluids Control is a stabilized suspension of human red blood cells and simulated white blood cells in a solution containing biological salts and anti-microbial preservatives. The product is packaged in glass vials containing 8ml. The closures are polypropylene screw caps with polyethylene liners. Four vials are included in a set. Two vials are level 1 with a low cell count and the other two vials are level 2 with a higher concentration of cells. The vials are further packaged in a six (6) welled vacuum formed "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 – 10°C.
Here's an analysis of the acceptance criteria and study information for the iQ® Body Fluids Control device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not explicitly state numerical acceptance criteria (e.g., minimum accuracy percentages, specific standard deviations). Instead, it describes general performance categories and concludes qualitative success.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Closed Vial Stability | "All testing showed that iQ Body Fluids Control is consistently reproducible and stable for the closed vial stability claim." |
| Open Vial Stability | "All testing showed that iQ Body Fluids Control is consistently reproducible and stable for the closed vial stability claim." (Note: The text specifically mentions "closed vial stability claim" after discussing open vial stability, implying open vial stability was also met, but the wording is slightly ambiguous.) |
| Alternate Site Testing | "All testing showed that iQ Body Fluids Control is consistently reproducible and stable for the closed vial stability claim." (Same note as above.) |
| Run-to-Run Reproducibility | "All testing showed that iQ Body Fluids Control is consistently reproducible and stable for the closed vial stability claim." (Same note as above.) |
| Overall Safety and Effectiveness | "iQ Body Fluids Control is a safe and effective product useful for controlling the Iris Diagnositc Body Fluid Module. It will perform as claimed when used in accordance with the package insert." |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not specify the sample size used for the test sets in any of the studies (closed vial stability, open vial stability, alternate site testing, or run-to-run reproducibility).
The data provenance is internal to Streck as the manufacturer. There is no information about the country of origin of the data or whether the studies were retrospective or prospective. Given these are stability and reproducibility studies for a control material, they would inherently be prospective in nature, conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable in the context of this device. The iQ® Body Fluids Control is a quality control material, not a diagnostic device that interprets medical images or patient data requiring expert consensus or ground truth establishment in the traditional sense. The "ground truth" for a control material would be its manufacturing specifications and target values, verified through laboratory assays.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reason as point 3. There is no expert adjudication involved in determining the performance of a hematology control material. Its performance is assessed against established laboratory standards and its own pre-defined target values and acceptable ranges.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that assist human readers in interpreting clinical cases (e.g., radiologists reading medical images). The iQ® Body Fluids Control is a quality control material for an analyzer, not a device used by human readers for diagnostic interpretation.
Effect Size: N/A, as no MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not directly applicable in the common sense of algorithm-only performance for a diagnostic device. However, the studies conducted (closed vial stability, open vial stability, alternate site testing, and run-to-run reproducibility) represent "standalone" performance of the control material itself when run on the iQ® Series analyzers. The device (the control material) is used independently by the analyzer to verify its performance specifications. There is no "human-in-the-loop" component for the control material's own performance evaluation; its function is to assess the analyzer's performance.
7. The Type of Ground Truth Used:
The "ground truth" for the iQ® Body Fluids Control would be its reference values and acceptable ranges established through rigorous assaying and manufacturing processes. These values are determined by:
- Manufacturer-defined specifications: The expected concentration of red blood cells and simulated white blood cells based on the formulation.
- Laboratory assay methods: The control material is tested using validated laboratory methods on suitable reference instruments to establish its target values and expected variability.
- Statistical analysis: To define the acceptable ranges for the control material's performance over its claimed stability period.
It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set:
This information is not applicable as the iQ® Body Fluids Control is a chemical reagent/biological control material, not an AI/machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is 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.