Search Results
Found 1 results
510(k) Data Aggregation
(27 days)
Liquichek TDM Is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes fisted in the package insert.
Liquichek™ TDM is prepared from human serum, with added constituents of nonhuman protein, drugs and preservatives. The control is provided in liquid form for convenience.
Here's a breakdown of the acceptance criteria and study information for the Liquichek™ TDM 1, 2, 3 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Open Vial Stability | Once thawed and opened, all analytes stable for 30 days when stored tightly capped at 2-8°C. Exceptions: T3 total and T3 free stable for 15 days; Diazepam stable for 24 hours. | "Once the control is thawed and opened, all analytes will be stable for 30 days when stored tightly capped at 2-8°C, with the following exceptions: Ta total and T3 free will be stable for 15 days and Diazepam will be stable for 24 hours days. Avoid repeated freezing and thawing of the quality control material." (Matches criteria) |
| Closed Vial Stability | When thawed and stored unopened at 2-8°C, all analytes stable for 180 days. Exceptions: Cortisol, Desipramine, T4 total and T3 free stable for 30 days. | "When the control material is thawed and stored unopened at 2-8° C all analytes will be stable for 180 days with the following exceptions: Cortisol, Desipramine, and T4 total and T3 free are stable for 30 days." (Matches criteria) |
| Shelf Life | 36 months when stored at -20°C or colder. | "Shelf Life: 36 months when stored at -20 °C or colder." (Matches criteria) |
| Substantial Equivalence | The new device (Liquichek™ TDM 1, 2, 3 with preservatives) should be substantially equivalent to the predicate device (Liquichek™ TDM 1, 2, 3 without preservatives) in terms of intended use, form, matrix, storage conditions (unopened frozen), analytes, storage (unopened thawed), and open vial claims, with the addition of preservatives. | The submission claims "substantial equivalence to the Liquichek™...in commercial distribution (K893682)." The comparison table explicitly shows that the "new device" (with preservatives) has the same intended use, form, matrix, storage (unopened frozen) and analytes as the "predicate device." Minor differences in specific analyte stability within the "unopened thawed" and "open vial claim" categories are noted, but these are addressed by the specific stability study findings. The FDA concludes with a "substantial equivalence determination." (Meets the implicit substantial equivalence criteria based on the provided comparison and FDA letter). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample size (number of control vials, number of tests conducted) used for the stability studies. It broadly refers to "stability studies" and "real time studies."
- Data Provenance: The studies were conducted by Bio-Rad Laboratories. The data is retained "on file at Bio-Rad Laboratories" in Irvine, California, USA. This indicates the data is likely retrospective but performed by the manufacturer. Specific country of origin for all data points (e.g., if external labs were used for any validation) is not detailed beyond Bio-Rad's location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device and study. The Liquichek™ TDM 1, 2, 3 is a quality control material. Its "ground truth" (i.e., its established analyte concentration and stability) is determined through analytical laboratory testing using established reference methods, not by expert consensus or interpretation of images/data by human experts. The performance data relates to the intrinsic stability of the chemical components within the control material, not human diagnostic accuracy.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in studies where human interpretation or diagnosis is involved and there's a need to resolve disagreements among experts. This is an analytical chemistry/device stability study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with/without AI
This is not applicable. This device is a quality control material, not an AI-powered diagnostic tool. Therefore, there are no "human readers," "AI assistance," or MRMC studies involved.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable. This is a laboratory control material, not an algorithm or software device.
7. The Type of Ground Truth Used
The "ground truth" for this device, which is a quality control material, is established by analytical laboratory measurements using reference methods for the various analytes. The stability studies evaluate whether the measured concentrations of these analytes remain within acceptable limits over time and under various storage conditions. The specific reference methods are not detailed in this summary but would be part of Bio-Rad's internal documentation.
8. The Sample Size for the Training Set
This is not applicable. As a quality control material, there is no "training set" in the context of machine learning or AI. The product's characteristics are developed through chemical formulation, manufacturing processes, and validated through stability testing.
9. How the Ground Truth for the Training Set Was Established
This is not applicable due to the absence of a training set. The "ground truth" for the product's performance (i.e., stability and assay values) is established through rigorous analytical testing and adherence to manufacturing specifications.
Ask a specific question about this device
Page 1 of 1