(35 days)
Lyphochek Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
This is a lyophilized product prepared from human whole blood containing preservatives and stabilizers.
The Bio-Rad Laboratories Lyphochek Diabetes Control is a quality control material, not a diagnostic device that measures patient outcomes or makes clinical decisions. Therefore, the typical acceptance criteria and study designs involving diagnostic performance metrics like sensitivity, specificity, or reader studies are not applicable.
Instead, the "acceptance criteria" for this type of device revolve around its stability and its ability to consistently monitor the precision of laboratory testing procedures for specific analytes over time. The "study" that proves the device meets these criteria is a stability study.
Here's a breakdown of the information requested, adapted for a quality control material:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance/Evidence |
|---|---|---|
| Open Vial Stability | The control material must maintain its stated analyte values and demonstrate acceptable precision for 7 days when stored at 2 to 8°C after opening. | "Open vial Stability: 7 days at 2 to 8°C." The device maintained its intended performance characteristics for 7 days after opening, under recommended storage conditions, allowing laboratories to reliably monitor assay precision during this period. The specific details of how "acceptable precision" was defined and measured are not provided in this summary but would be part of the full stability study. |
| Shelf Life | The control material must maintain its stated analyte values and demonstrate acceptable precision for 3 years when stored unopened at 2 to 8°C. | "Shelf Life: 3 Years at 2 to 8°C." The device maintained its intended performance characteristics for 3 years when stored unopened, under recommended storage conditions, ensuring its usability for the stated period. The specific details of how "acceptable precision" was defined and measured are not provided in this summary but would be part of the full stability study. |
| Claimed Analytes | The device must reliably monitor the precision of laboratory testing procedures for the claimed analytes, specifically including Total Hemoglobin (which is the new claim). | The device's formulation is "exactly the same" as the predicate, which already had claims for Hemoglobin A1C, Hemoglobin A1, Hemoglobin F, and Total Glycated Hemoglobin. The new device adds a claim for Total Hemoglobin. The stability study implicitly validates the stability for this new analyte alongside the others. While specific data isn't shown, the FDA found it substantially equivalent based on the provided data. |
Important Note: The provided summary does not detail the specific metrics used to define "acceptable precision" for the analytes (e.g., specific coefficients of variation or acceptable biases) or the raw data from the stability studies. These would be found in the full submission to the FDA.
2. Sample Size Used for the Test Set and the Data Provenance
This is not applicable in the traditional sense for a quality control material's stability study.
- "Test Set": In a stability study for a QC material, the "test set" would be various lots of the manufactured control material that are subjected to different storage conditions and timepoints. The number of vials/aliquots tested at each time point would constitute the "sample size" for that specific test run. The document does not specify the number of lots or aliquots used in the stability studies.
- Data Provenance: Not specified, but generally, such studies are conducted internally by the manufacturer (Bio-Rad Laboratories in Irvine, California, USA) according to established quality system procedures and regulatory guidelines. It would be prospective, as the stability of newly manufactured batches is monitored over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable. For a quality control material, the "ground truth" for its analyte values is established through reference methods or highly accurate assays performed in a controlled laboratory setting by qualified analytical chemists or laboratory scientists during the manufacturing and characterization process. It's not based on expert consensus for interpretation like in diagnostic imaging.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert interpretations of diagnostic data. For a stability study, the data points are quantitative measurements of analyte concentrations, and any discrepancies would be resolved through re-testing, statistical analysis of replicates, or investigation of assay performance, not expert adjudication of qualitative interpretations.
5. 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
This is not applicable. This type of study is relevant for diagnostic devices, particularly those involving human interpretation, often assisted by AI. The Lyphochek Diabetes Control is a reagent used to monitor the precision of laboratory instruments, not a device that humans directly interpret for diagnostic purposes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable. This device is a physical control material, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the analyte values (e.g., the target values for Hemoglobin A1C, Total Hemoglobin, etc.) in the Lyphochek Diabetes Control would be established through a combination of:
- Reference Methods: Highly accurate and precise analytical methods (e.g., HPLC, mass spectrometry) that are traceable to international reference materials.
- Certified Reference Materials (CRMs): The control material would be assayed against CRMs to assign accurate target values for the analytes.
- Internal Characterization Studies: Extensive testing during manufacturing to determine the mean and acceptable range for each analyte in each lot.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of a quality control material stability study. The control material's characteristics are determined through analytical testing, not machine learning or algorithmic training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set. The "ground truth" for the control material's characteristics (analyte values and stability) is established through rigorous analytical testing using reference methods and comprehensive stability studies, as described in 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.