(35 days)
For IN VITRO diagnostic use as a calibrator in clinical chemistry assays for UIBC (Unsaturated Iron Binding Capacity). DC-UIBC-CAL may be used to check the linearity over the reportable patient range of UIBC assays.
DC-UIBC-CAL is a human based, lyophilized serum intended for use as a calibrator with Sekisui Diagnostics UIBC Assays. The concentrations and activities of the UIBC (Unsaturated Iron Binding Capacity) is optimized for the calibration of clinical chemistry systems - Beckman Coulter AU® Systems, Roche/Hitachi® Beckman Coulter SYNCHRON® Systems, and Cobas Mira®.
The DC-UIBC-CAL kit consists of the following:
Six vials with 10mL of lyophilized serum.
Human serum was used in the manufacture of this product. The human serum in this product has been prepared exclusively from the blood of donors tested individually and shown by FDAapproved methods to be free from HBsAg and antibodies to HCV and HIV. However, as no test method can rule out the potential risk of infection with absolute certainty, the material should be treated just as carefully as a patient sample. In the event of exposure, the directives of the responsible Health Authorities should be followed.
The provided text describes a 510(k) submission for a medical device called DC-UIBC-CAL, a calibrator for clinical chemistry assays. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than a full de novo performance study. As such, many of the typical elements requested for software-based AI/ML device studies are not present.
Here's an analysis based on the provided text, indicating where information is present and where it is not applicable or not provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" in the format typically seen for diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device.
The reported performance is primarily around stability and traceability/value assignment.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate | The information presented in the premarket notification demonstrates that the performance of the Sekisui Diagnostics modified DC-UIBC-CAL is substantially equivalent to the cleared predicate device. |
| Shelf Life Stability | Accelerated stability studies for shelf life were conducted, and acceptance criteria were met. The DC-UIBC-CAL is stable at 2-8 °C for 36 months or until the expiration date. Real-time studies are ongoing. |
| Open Vial Stability (Reconstituted) | Acceptance criteria were met. Reconstituted product is stable at 2-8 °C for 14 days. |
| Traceability of UIBC Values | UIBC values are traceable to NIST SRM 937. Sekisui verifies UIBC is within acceptable target range using Sekisui protocol. |
| Target Range Consistency Across Instruments | For UIBC-SL Reagent 153-10/30/50/90, the target range across Beckman Coulter AU, Beckman Coulter SYNCHRON, Roche/Hitachi, and Cobas Mira systems is 208 – 312 µg/dL. Specific target values are provided (e.g., 238 µg/dL for Beckman Coulter AU Systems). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document relates to a calibrator, not a diagnostic test for patient samples. Therefore, the concept of a "test set" for patient data, sample size, and data provenance (country, retrospective/prospective) as typically applied to diagnostic algorithms is not applicable here.
The stability studies would have involved multiple units of the calibrator product. The traceability and value assignment involved using two reagent lots on instruments. No specific sample sizes for these internal validation tests are provided.
The device itself is manufactured using human serum, and mentions that "Human serum was used in the manufacture of this product."
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. The device is a calibrator, not an interpretative AI/ML diagnostic device. Ground truth for a calibrator relates to its chemical composition and assigned values, which are established through metrological traceability to reference materials (like NIST SRM 937) and internal protocols, not through expert human review of diagnostic outputs.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable for a calibrator device.
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 is not an AI/ML diagnostic device for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a calibrator, a physical reagent device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the calibrator's UIBC concentration is established through metrological traceability to a reference material, specifically NIST SRM 937 (National Institute of Standards and Technology Standard Reference Material 937). Internal Sekisui protocols are also used for value assignment. This is a chemical/physical ground truth, not a clinical ground truth like pathology or patient outcomes.
8. The sample size for the training set
Not applicable. This is a calibrator, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.