(27 days)
Liquichek Hematology Control (A) is an assayed whole blood control for evaluating precision of hematology Instruments that provide a white blood cell differential.
Liquichek Hematology Control (A) is a suspension of stabilized human white colls, simulated Liquichek Hernalorogy Continer (A) is a suspention of cells. This product onnains soluble human plateles of animal ongin, and lifestablity of the cellular components. This product is provided in liquid form.
Here's an analysis of the provided text regarding the K041457 submission for the Liquichek Hematology Control (A), focusing on acceptance criteria and supporting studies:
This submission is for a medical device that serves as a quality control mixture for hematology instruments. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a novel clinical benefit or diagnostic accuracy in humans. Therefore, the "acceptance criteria" and "study" are interpreted in the context of stability and performance within a laboratory setting for quality control.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are demonstrated through stability studies. The reported performance directly addresses these stability claims.
| Acceptance Criteria | Reported Device Performance (Summary of Study Results) |
|---|---|
| Open Vial Stability | All analytes are stable for 7 days when stored at 2 to 8°C. |
| Shelf Life | 60 days when stored at 2 to 8°C. |
Note: The document states that "All supporting data is retained on file at Bio-Rad Laboratories." This implies that the detailed results backing these claims are available but not explicitly presented in this summary document. The "performance claims were established using the Abbott Cell-Dyn 3000," which is the instrument used to test the control's stability for the specified analytes.
Detailed Information Regarding the Study:
Given that this is a quality control device submission, many of the typical clinical study parameters (like human patient sample sizes, expert qualifications for ground truth, MRMC studies) are not applicable. The study conducted here focuses on the stability and performance of the control solution itself.
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated in the provided summary. The stability studies would involve multiple units/vials of the Liquichek Hematology Control (A) tested at various time points over 7 days (open vial) and 60 days (shelf life). The instrument used was the Abbott Cell-Dyn 3000.
- Data Provenance: Not explicitly stated beyond Bio-Rad Laboratories, Irvine, California (the submitter). Given it's a control manufactured by Bio-Rad, the studies likely originate from their internal testing facilities. It is a prospective study as it involved testing the stability of the manufactured control over time.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable directly. For a quality control material, the "ground truth" would be the known or assigned values for each analyte in the control solution. This is established through rigorous internal testing and calibration by the manufacturer, rather than by human expert interpretation for individual cases. The "experts" in this context would be the laboratory personnel and scientists involved in the formulation, characterization, and testing of the control material.
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Adjudication Method for the Test Set:
- Not applicable. Adjudication typically refers to resolving discrepancies among human readers or interpretations of diagnostic results. For a quality control device's stability study, the performance is measured against predefined analytical specifications or established target values, and any deviations would be handled through standard laboratory quality control processes, not through expert adjudication in the medical diagnostic sense.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. An MRMC study is relevant for comparing the diagnostic accuracy of a device (often image-based or involving human interpretation) with and without AI assistance across multiple readers and cases. This device is a diagnostic control, not a diagnostic device that humans interpret.
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If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done:
- Yes, effectively. The "study" for this device involved testing the stability of the control solution on a hematology analyzer (Abbott Cell-Dyn 3000). This is essentially a standalone performance evaluation of the control material, as it does not involve human interpretation of its results for diagnostic purposes. The instrument reads the control, and its values are compared against expected ranges.
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The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for a quality control material is its assigned value or target range for each analyte. These values are established by the manufacturer (Bio-Rad Laboratories) through extensive characterization and calibration using reference methods and/or validated master lot values. It is based on analytical measurements and metrological traceability, not expert consensus on individual cases.
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The Sample Size for the Training Set:
- Not applicable. This device is a quality control material and is not an AI algorithm or a diagnostic device that requires a "training set" in the machine learning sense. Its performance is characterized through direct analytical testing for stability and equivalence to a predicate.
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How the Ground Truth for the Training Set Was Established:
- Not applicable. As stated above, there is no "training set" in the context of this device. The ground truth for the control material itself (its assigned values) is established through manufacturing and assay processes by Bio-Rad Laboratories.
§ 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.