(25 days)
C.f.a.s. PUC is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
Precinorm ® PUC (Proteins in Urine/CSF) is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. Precipath ® and present in Urine/CSF) is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
C.f.a.s. PAC is a liquid, ready-for-use calibrator consisting of a buffered aqueous solution with biological materials added as required to obtain desired component levels. Values for constituent analytes are provided in the product labeling.
Precinorm ® PUC/ Precipath ® PUC is a liquid ready-for-use control based on a buffered aqueous solution. Concentrations of control components have been adjusted to represent normal and pathological ranges. Values for constituent analytes are provided in the product labeling.
This looks like a 510(k) Pre-market Notification for a medical device. The provided text is a summary of the similarities between a new device and an existing "predicate" device, which is the basis for claiming "substantial equivalence" to qualify for FDA approval.
However, the provided document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria. Instead, it focuses on demonstrating that the new devices (C.f.a.s. PUC, Precinorm® PUC, and Precipath® PUC) are substantially equivalent to their previously cleared predicate devices by highlighting their shared intended use, format, stability, and the analytes they measure.
The key information is that the new devices have added Immunoglobulin G to the list of constituent analytes compared to their predicates. The company is asserting that despite this addition, the new devices are still substantially equivalent.
Therefore, many of the questions you've asked cannot be answered directly from the provided text, as it's not a study report detailing performance against specific criteria, but rather a regulatory submission for substantial equivalence.
Here's an attempt to answer based on the information provided and what can be inferred:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria or reported device performance in the way a clinical study report would. The "performance" being demonstrated here is the substantial equivalence to predicate devices. The implicit acceptance criterion for this submission is that the modifications (addition of Immunoglobulin G as an analyte) do not raise new questions of safety and effectiveness, and the device performs as expected for a calibrator/quality control.
| Acceptance Criteria (Implied for Substantial Equivalence Claim) | Reported Device Performance (Summary of Similarities) |
|---|---|
| C.f.a.s. PUC: | |
| - Intended Use is the same as predicate. | - Same: Calibration of quantitative Roche methods on Roche clinical chemistry analyzers. |
| - Format is the same as predicate. | - Same: Liquid, ready-for-use calibrator, buffered aqueous solution, biological materials. |
| - Stability is the same as predicate. | - Same: Unopened stable at 2-8°C until expiration; Opened stable at 2-8°C for 4 weeks. |
| - Level is the same as predicate. | - Same: Single level. |
| - Constituent Analytes are similar or safely expanded. | - Added Immunoglobulin G (IgG) to Albumin and Total protein. The submission implies this addition does not change substantial equivalence from the predicate which had only Albumin and Total protein. Although not explicitly stated as performance, the implication is that the device accurately calibrates for IgG. |
| Precinorm® PUC / Precipath® PUC: | |
| - Intended Use is the same as predicate. | - Same: Quality control by monitoring accuracy and precision for quantitative methods. |
| - Format is the same as predicate. | - Same: Liquid, ready-for-use control, buffered aqueous solution, concentrations adjusted for normal and pathological ranges. |
| - Stability is the same as predicate. | - Same: Unopened stable at 2-8°C until expiration; Opened stable at 2-8°C for 4 weeks. |
| - Constituent Analytes are similar or safely expanded. | - Precinorm®: Added Immunoglobulin G (IgG) to Albumin, Creatinine, Total Protein. |
- Precipath®: Added Immunoglobulin G (IgG) to Albumin, Creatinine, Total Protein, Immunoglobulin A, Immunoglobulin M.
The submission implies this addition does not change substantial equivalence from the predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. This document isn't a study report with test set details. For a calibrator/control device, testing typically involves assessing accuracy, precision, linearity, and stability, but the details of such assessments are not included in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. This device is a calibrator and control, not an interpretative diagnostic device that would require expert "ground truth" establishment in the context of clinical images or patient data. The "ground truth" for calibrators and controls is established through rigorous analytical methods to assign target values to the analytes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. As above, this type of adjudication is relevant for diagnostic devices that interpret patient data, not for calibrators/controls that undergo analytical validation.
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 information is not applicable and not provided. MRMC studies are used for diagnostic devices, particularly imaging AI, not for calibrators/controls. This device does not involve human readers' interpretation or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. There is no "algorithm" in the sense of AI performance for this type of device. The device's performance relates to its chemical and physical properties as a calibrator/control.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for calibrators and controls is established through assigned values derived from highly accurate and precise analytical reference methods, often traceable to international reference materials. While the specific methods used to assign values for C.f.a.s. PUC, Precinorm® PUC, and Precipath® PUC are not detailed in this summary, it would typically involve:
- Reference materials: Using certified reference materials or reference measurement procedures to ensure accuracy.
- Method validation: Thorough validation of the methods used for value assignment.
- Traceability: Ensuring traceability of assigned values to higher-order reference measurement systems.
8. The sample size for the training set
This information is not applicable and not provided. This device is not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided. As there is no training set, this question is not relevant.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.