(30 days)
COULTER LIN-C linearity controls are intended to verify the reportable range 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.
LIN-C linearity controls are stabilized human blood components from which repeated measurements are made to verify the reportable range of Beckman Coulter hematology systems.
Acceptance Criteria and Study for COULTER® LIN-C® Linearity Control (K061064)
This submission describes the COULTER® LIN-C® Linearity Control, a device intended to verify the reportable range of COULTER hematology analyzers. The primary focus of this 510(k) is on the additional levels of this control covering an extended cellular component range. Therefore, the "device" in question refers to these additional levels of the linearity control.
The document does not explicitly state specific numerical acceptance criteria for the device's performance. Instead, it relies on the concept of "substantial equivalence" to a predicate device. The performance data section broadly states: "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution."
However, the nature of a linearity control implies certain performance characteristics, primarily stability and the ability to accurately represent the linearity of the analytical system within its reportable range.
1. Table of Acceptance Criteria and Reported Device Performance
Given the lack of explicit quantitative acceptance criteria in the provided document, we infer the criteria based on the device's function and the summary provided.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | The additional levels of COULTER LIN-C linearity controls are "essentially identical" to the current COULTER LIN-C linearity controls (K955334), with the exception of the additional levels covering an extended cellular component range and the analyzers on which it may be used. |
| Stability (Open Vial) | Supports claims of 7 open vial days. |
| Stability (Closed Vial) | Supports claims of 120 closed vial days. |
| Verification of Reportable Range | Intended to verify the reportable range of COULTER hematology analyzers. (Performance data implicitly supports this through the substantial equivalence claim). |
| Safety and Effectiveness | "Supports a finding of substantial equivalence to products already in commercial distribution." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states "data in the Premarket Notification on safety and effectiveness."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device (a quality control mixture) does not typically involve human experts establishing "ground truth" in the way an imaging device or diagnostic test might. Instead, the "ground truth" for a linearity control would be established by reference methods or highly calibrated instruments. The document does not provide any information on the number or qualifications of experts involved in establishing ground truth, as it's not directly applicable in the conventional sense for this product.
4. Adjudication Method
Not applicable for this type of device. The performance of a linearity control is assessed through objective measurements on hematology analyzers, not through human interpretation or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are typically performed for devices where human readers interpret results (e.g., medical imaging). This device is a quality control material, not a diagnostic interpretation tool for human readers.
6. Standalone Performance Study
Yes, a standalone performance study was implicitly done to support the stability claims and demonstrate substantial equivalence. The "Summary of Performance Data" states: "Stability studies of COULTER LIN-C linearity controls support the Beckman Coulter stability claims of 7 open vial days and 120 closed vial days." This indicates direct testing of the control material's stability characteristics. The overall "safety and effectiveness" data also falls under standalone performance, as it pertains to the device itself.
7. Type of Ground Truth Used
The "ground truth" for a linearity control would involve measurements obtained from calibrated reference instrumentation or validated methods against which the control material's behavior is compared to ensure it performs as expected across the analytical range. The document does not explicitly state the specific type of ground truth, but for linearity controls, it would generally be analytical measurements using established and accurate laboratory techniques.
8. Sample Size for the Training Set
The document does not provide information on the sample size for a training set. This is likely because the development of a linearity control involves formulation and characterization rather than a typical machine learning "training" process.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the typical sense of a "training set" for an algorithm. The ground truth for the development and characterization of the linearity control would have been established through extensive laboratory testing using validated methodologies and reference materials to accurately determine the expected values and stability characteristics across its intended range.
§ 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.