(34 days)
5C Cell Control is a hematology quality control material used to monitor the performance of COULTER hematology analyzers listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents (Refer to your Product Manuals or On-line Help System.)
The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor instrument performance. This product can also be used to establish your own laboratory mean.
5C Cell Control is a reference product prepared from treated, stabilized human erythrocytes in an isotonic, bacteriostatic medium. 5C Cell Control also contains a stabilized, platelet-sized component, and fixed erythrocytes to simulate leukocytes. By design, 5C Cell Control confirms and monitors instrument accuracy and precision performance by providing measurements for counting, sizing, hemoglobin determination and White Blood Cell differentiation using VCS technology.
The provided 510(k) summary (K060464) describes the addition of a new parameter (RDW-SD) to an existing device, the COULTER® 5C® Cell Control. It explicitly states that the control product formulation and manufacturing processes were not modified to obtain the additional parameter. Because the device itself (the control material) is not being altered and is simply being used to monitor a new, derived parameter, the submission focuses primarily on stability studies of the control material with the RDW-SD parameter, rather than a comparative effectiveness study of the control material against a separate ground truth for RDW-SD.
Therefore, many of the requested elements for a study that "proves the device meets the acceptance criteria" are not directly applicable or are not explicitly detailed in this type of submission. The acceptance criteria generally relate to the stability of the control material, and its ability to provide consistent RDW-SD values over time suitable for monitoring instrument performance.
Here's an attempt to answer based on the provided document, addressing each point as much as possible:
Acceptance Criteria and Reported Device Performance
The document states: "Stability studies of 5C Cell Control with RDW-SD parameter support the Beckman Coulter stability claims of 13 events within 13 days (open vial) and 95 days (closed vial)." This implies that the acceptance criteria for the "device" (the control material with the RDW-SD parameter) are its stability within these timeframes. The reported performance is that it meets these stability claims.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Stability: 13 events within 13 days (open vial) | Supported (meets claims) |
| Stability: 95 days (closed vial) | Supported (meets claims) |
Note: The specific numerical ranges or statistical measures used to demonstrate "stability" (e.g., coefficient of variation, deviation from target values) are not provided in this summary. These would typically be detailed in the full premarket notification but are summarized here by directly stating support for the claims.
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "stability studies" without detailing the number of control vials, lots, or measurements taken.
- Data Provenance: Not explicitly stated. It is implied to be from internal Beckman Coulter studies, likely conducted in their facilities. The country of origin is not specified, but Beckman Coulter is a US-based company, suggesting the studies would be conducted in the US or under US regulatory standards. The studies would be prospective in nature, as they are designed to test the stability of newly manufactured control material over time.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the conventional sense. For a quality control material like 5C Cell Control, "ground truth" for a parameter like RDW-SD is typically established by:
- Traceability to a reference measurement procedure: The instrument that measures RDW-SD is calibrated against reference methods or materials.
- Consensus values from multiple instruments: The manufacturer determines expected values and ranges for their control material by running it on multiple, well-calibrated instruments.
- There is no mention of human experts directly establishing a "ground truth" for RDW-SD values on the control material in the context of this 510(k) summary. The ground truth would be the expected or assigned values based on instrument performance and calibration.
- Not applicable in the conventional sense. For a quality control material like 5C Cell Control, "ground truth" for a parameter like RDW-SD is typically established by:
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Adjudication method for the test set:
- Not applicable. This is not a study requiring human interpretation or adjudication (e.g., image reading). The "test set" would be the measurements of RDW-SD from the control material over time. Data validity would be assessed by statistical methods against predefined acceptance criteria for stability.
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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:
- Not applicable. This device is a hematology quality control material, not an AI-assisted diagnostic tool or an imaging device requiring human readers or adjudication.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a control material for an automated hematology analyzer. The "algorithm" here would be the analyzer's software that calculates RDW-SD from the raw RBC histogram data. The stability studies assess the control's ability to consistently challenge this algorithm and the overall instrument performance. The human-in-the-loop is the laboratory technologist monitoring the results against the expected range.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the RDW-SD parameter of the 5C Cell Control is the assigned value and expected range provided by Beckman Coulter. These values are derived from extensive testing on their hematology analyzers (as mentioned, on a new COULTER hematology analyzer that is described as having a "510k submission pending" for its RDW-SD capability). This established value acts as the reference for monitoring instrument accuracy and precision, which is the intended use of the control. It's essentially a manufacturer-established reference value based on instrument performance and calibration.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
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How the ground truth for the training set was established:
- Not applicable.
§ 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.