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510(k) Data Aggregation
(22 days)
LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563
Lyphochek® Whole Blood 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.
Lyphochek® Whole Blood Control is prepared from human whole blood, with pure chemicals, and stabilizers added. The control is provided in lyophilized form for increased stability.
The provided text is a Premarket Notification (510(k)) for the Lyphochek® Whole Blood Control, which is a quality control material used for laboratory analytes. This type of device is not an AI/ML device and therefore the questions regarding acceptance criteria and studies that prove the device meets acceptance criteria in the context of AI/ML are not directly applicable.
The document focuses on demonstrating substantial equivalence to a previously marketed predicate device (K980871) by showing similar intended use, form, and matrix, while highlighting the addition of a new analyte (Sirolimus).
However, I can extract the information related to the device's performance based on the type of product it is (a quality control material).
Description of Device and Basis for Approval
The Lyphochek® Whole Blood Control is a lyophilized human whole blood-based control material intended to monitor the precision of laboratory tests for various analytes. The 510(k) submission seeks to establish substantial equivalence to a previously cleared device (K980871), with the primary difference being the inclusion of Sirolimus as an additional analyte.
The approval is based on demonstrating that the new device has the same intended use, fundamental technology (lyophilized human whole blood matrix), and comparable performance (stability) to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
For a quality control material like Lyphochek® Whole Blood Control, 'acceptance criteria' typically relate to its stability and ability to maintain the target values for analytes over time.
| Characteristic | Acceptance Criteria (Performance Claim) | Reported Device Performance (Summary of Performance Data) |
|---|---|---|
| Reconstituted Stability | All analytes stable for 14 days at 2°C to 8°C. Exception: Red Cell Folate stable for 3 days at 2°C to 8°C. | "Once the control material is reconstituted, all analytes will be stable for 14 days at 2℃ to 8 ℃ with the following the exception: Red Cell Folate will be stable for 3 days at 2°C to 8°C." This directly matches the claim/criterion. |
| Shelf Life (Unopened) | Three years and three months when stored at 2°C to 8°C. | "Three years and three months when stored at 2 to 8 °C." This directly matches the claim/criterion. "Real time studies will be ongoing to support the shelf life of this product. All supporting data is retained on file at Bio-Rad Laboratories." This indicates a commitment to ongoing validation. |
| Frozen Stability (after reconstitution) | All analytes stable for 30 days when stored tightly capped at -10°C to -20°C. | The table of similarities and differences states: "After reconstituting and freezing the control, all analytes will be stable for 30 days when stored tightly capped at -10 to -20°C." This matches the claim/criterion. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Stability studies have been performed to determine the reconstituted stability and shelf life for the Lyphochek® Whole Blood Control." It also mentions, "All supporting data is retained on file at Bio-Rad Laboratories."
- Sample size for the test set: Not explicitly stated in the provided summary. However, for real-time stability studies of a diagnostic reagent, a statistically significant number of vials/lots would be tested over time.
- Data provenance: Not explicitly stated, but as Bio-Rad Laboratories is a US-based company, it is likely tested in the US. The studies are prospective in nature, as they involve monitoring the product over time to establish stability claims.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This question is not applicable. The device is a quality control material, not a diagnostic device that requires expert interpretation for a "test set ground truth." The "ground truth" for a control material is its chemical composition and stability, which is determined through analytical reference methods and validated manufacturing processes, rather than expert consensus on clinical findings.
4. Adjudication Method for the Test Set
This question is not applicable for the same reasons as #3. Adjudication methods (e.g., 2+1) are for interpreting complex clinical data, not for verifying the stability of a chemical reagent.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
This question is not applicable. An MRMC study is designed to evaluate the effectiveness of an AI system, often in imaging, by comparing human reader performance with and without AI assistance across multiple cases and readers. The Lyphochek® Whole Blood Control is a laboratory reagent, not an AI/ML diagnostic system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
This question is not applicable, as the device is not an algorithm or AI/ML system.
7. The Type of Ground Truth Used
The "ground truth" for a quality control material like this would be established through:
- Quantitative analytical methods: Using highly accurate and precise analytical instruments and reference methods to precisely determine the concentration of each analyte within the control material at different time points and under different storage conditions.
- Reference material traceability: Ensuring the values are traceable to international or national reference materials where available.
- Manufacturing specifications: The material is manufactured to specific chemical formulations, and its performance is assessed against these established specifications.
8. The Sample Size for the Training Set
This question is not applicable. The device is not an AI/ML system, and therefore does not have a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8.
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