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510(k) Data Aggregation
(98 days)
For In Vitro Diagnostic Use Only.
Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analysis of AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA.
This quality control product can be used as an objective judgment of the laboratory's procedures and personnel techniques. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing systems within the clinical range.
This document describes the Fujirebio Diagnostics Tumor Marker Control, a quality control product intended to monitor the precision of laboratory testing procedures for various tumor markers. It is a Class I, reserved medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative sense for the device's performance as a control material. Instead, its performance is measured by its equivalence to a predicate device in terms of intended use, analytes, matrix, form, and stability. The performance is reported by comparing its features and characteristics to those of the predicate devices.
| Feature / Criterion | Fujirebio Diagnostics Tumor Marker Control (Proposed Device) | Bio-Rad Lyphochek® Tumor Marker Plus Control (Predicate) / ARCHITECT HE4 Control Kit (Predicate for HE4) |
|---|---|---|
| Device Type | In vitro diagnostic | In vitro diagnostic |
| Classification | Class I, reserved | Class I, reserved |
| CFR section | 862.1660 | 862.1660 |
| Product Code | JJY | JJY |
| Product Usage | Clinical and Hospital laboratories | Clinical and Hospital laboratories |
| Intended Use | Assayed control serum to monitor the precision of laboratory testing procedures for AFP, CA15-3, CA19-9, CA125, CEA, Ferritin, HE4, PSA and Free PSA. | Assayed quality control serum to monitor precision for analytes listed in package insert (Lyphochek). Verification of accuracy and precision for ARCHITECT i System (HE4). |
| Matrix | Human Serum | Human Serum (Lyphochek); Protein buffer (ARCHITECT HE4) |
| Form | Lyophilized | Lyophilized (Lyphochek); Liquid (ARCHITECT HE4) |
| Analytes | AFP, CA 15-3, CA 19-9, CA 125, CEA, Ferritin, HE4, PSA, Free PSA | AFP, CA 15-3, CA 19-9, CA 125, CEA, Ferritin, PSA, Free PSA (Lyphochek); HE4 (ARCHITECT HE4) |
| Stability - Reconstituted at 2-8°C | 14 days at 2-8°C, except Free PSA (7 days) | 14 days at 2-8°C, except Free PSA (7 days) |
| Number of Levels | 2 | 3 |
| PSA Stability (reconstituted) | Total PSA - 14 days, Free PSA - 7 days | Total PSA – 7 days, Free PSA - 7 days |
| Reconstitution Volume | 3.0 mLs | 2.0 mLs |
| Additional Analytes | HE4 (Human Epididymis Protein 4) | ACTH, Aldosterone, Beta-2-Microglobulin, CA 27.29, Calcitonin, hCG, Prolactin, Prostatic Acid Phosphatase, and Thyroglobulin (Lyphochek) |
| Stability (unopened) | 18 months at 2-8°C | 3 years at 2-8°C (Lyphochek); 9 Months (ARCHITECT HE4) |
| Stability - Reconstituted at 2-8°C | CEA and Total PSA 14 days at 2-8°C | CEA 11 days at 2-8°C, Total PSA 7 days at 2-8°C |
| Stability - Reconstituted at <-20°C | All analytes are stable for 60 days when stored at <-20°C | All analytes are stable for 30 days when stored at <-20°C |
| Stability - Freeze/thaw | May be frozen and thawed repeatedly for up to 9 cycles | No claim made for freeze/thaw stability |
| Endogenous (Non-Spiked) analytes | CA 242 and CA 27.29* | None |
The acceptance criterion for this 510(k) submission is "Substantial Equivalence" to the predicate devices. The study provided is a comparative analysis demonstrating that the proposed device is substantially equivalent to the predicate devices despite some differences in specific characteristics, which are deemed not to raise new questions of safety or effectiveness.
2. Sample size used for the test set and the data provenance:
The document does not detail a specific "test set" in the context of patient samples or data. This is a quality control material, not a diagnostic test for patient samples. The "test set" implicitly refers to the control material itself, which was likely tested by the manufacturer to establish its stability, assigned values, and other characteristics compared to the predicate device.
Data provenance: Not explicitly stated, but assumed to be from internal laboratory testing of the control material (manufacturer's data). The country of origin of the data is not specified but would likely relate to the manufacturer's testing facilities (Fujirebio Diagnostics, Inc., Malvern, PA, USA and Fujirebio Diagnostics, AB, Gothenburg, Sweden). It would be prospective in nature, as the control material itself would be tested according to a protocol.
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):
Not applicable in this context. The "ground truth" for a quality control material is typically established through rigorous analytical testing to determine its assigned values and stability characteristics, often referencing established reference methods or certified reference materials, not through expert consensus in a clinical diagnostic sense. The document does not specify experts involved in establishing these analytical truths.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used in clinical studies where expert consensus is required for classification or diagnosis, which is not the case for a quality control material's analytical characterization.
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:
Not applicable. This device is a quality control material, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for a quality control material like this involves:
- Assigned Values: Established through multiple analyses using validated methods, potentially referencing international standards or reference materials for the specific analytes.
- Stability data: Determined by conducting real-time and accelerated stability studies of the product under various conditions.
- Matrix comparability: Demonstrated through analytical testing to ensure the control matrix behaves similarly to clinical samples in assays.
The document implies that these analytical ground truths were established through standard laboratory practices for quality control manufacturing but does not detail the specific methodologies or reference standards used.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set is used for this device.
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