(42 days)
Cell-Chex Auto is an assayed whole blood control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples.
Cell-Chex Auto 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 plastic vials containing 4ml. The closures are polypropylene screw caps with polyethylene liners. There are three different levels, Level 1 with a very low count, Level with a low count, and a Level 3 with a higher count. The vials will be packaged in a six (6) or twelve (12) welled vacuum formed "clam-shell" container with the package insert / assay sheet. The product must be stored at 2 - 10°C.
The provided text describes the 510(k) summary for the Cell-Chex Auto device. However, it does not contain specific acceptance criteria with numerical targets or a detailed study report that proves the device meets those criteria in the typical format of a clinical trial or performance study comparing against a gold standard with statistical measures.
Instead, the submission focuses on stability and reproducibility studies to demonstrate substantial equivalence to a predicate device.
Here's an attempt to extract the requested information based on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Specified" due to the nature of this particular 510(k) submission:
Acceptance Criteria and Device Performance
The acceptance criteria are implied to be "consistent reproducibility" and "stability for the shelf life claimed," demonstrating substantial equivalence to the predicate device, iQ® Body Fluids Control (K051706). No specific numerical acceptance criteria (e.g., a target coefficient of variation, accuracy percentage, or confidence intervals) are explicitly stated in the provided text.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Closed Vial Stability: Demonstrated stability for a specified period. | "75 days closed vial stability" (Improved from predicate's 159 days, but still a defined stability period). The study conclusion states it meets "the claim of a 75 day closed vial stability." |
| Open Vial Stability: Demonstrated stability after opening. | "30 day open vial stability." The study conclusion states it meets "the claim of... a 30 day open vial stability." |
| Run to Run Reproducibility: Consistent performance across multiple runs. | "consistently reproducible," "consistent run-to-run performance," and "Reproducibility studies... [show] consistency in the manufacture of Cell-Chex Auto." No specific quantitative metrics (e.g., CV%) are provided in this summary. |
| Site to Site Recovery of Values: Consistent performance across different testing sites. | "All testing showed that Cell-Chex Auto is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed." This implies acceptable recovery of values, but no specific data or metrics are presented. |
| Substantial Equivalence to Predicate | Implied Performance: "All testing showed that Cell-Chex Auto is... substantially equivalent to the predicate product." The comparison highlights similarities (assayed control, 30-day open vial stability, automated body fluid controls) and a difference (closed vial stability duration). No specific comparison data (e.g., bias, correlation) is provided. |
Detailed Study Information:
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified in the provided text. The submission mentions "four types of studies" but does not detail the number of samples or runs performed for each.
- Data Provenance: Not specified (e.g., country of origin). The studies were conducted by the manufacturer, Streck.
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Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This device is a quality control material, not a diagnostic device that requires expert interpretation of results to establish ground truth for a test set. Its performance is evaluated based on its own stability characteristics and reproducibility when run on instruments, likely against a reference assay or manufacturer's target values rather than expert-derived ground truth.
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Adjudication Method for the Test Set:
- Not Applicable. (See point 2).
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is typically for evaluating diagnostic imaging or pathology devices where multiple readers interpret cases. Cell-Chex Auto is a quality control material.
- Effect Size: Not applicable.
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Standalone Performance (Algorithm Only without Human-in-the-Loop Performance) Study:
- Yes, implicitly. The studies described (Closed Vial Stability, Open Vial Stability, Run to Run Reproducibility, and Site to Site recovery of values) assess the performance of the control material itself. While hematology instruments are involved, the focus is on the inherent characteristics of the Cell-Chex Auto product rather than a diagnostic algorithm or human interpretation. The "results consistency in the manufacture of Cell-Chex Auto" and its stability are the key performance indicators.
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Type of Ground Truth Used:
- Manufacturer's Reference Values / Established Stability Protocols: For a quality control material, the "ground truth" for stability and reproducibility studies typically refers to the manufacturer's established target values or range for the control material, and the adherence to pre-defined stability protocols (e.g., measuring values over time at specified conditions and comparing them to initial values or expected ranges). It is not pathology, expert consensus, or outcomes data in this context.
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Sample Size for the Training Set:
- Not Applicable. This device is a quality control material, not an AI/ML algorithm that requires a "training set." Its development involves formulation, manufacturing process control, and performance testing, not algorithmic training.
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How the Ground Truth for the Training Set was Established:
- Not Applicable. (See point 7).
§ 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.