(51 days)
CLINIQA Liquid QC™ Bilirubin Controls Levels 1, 2 & 3 are intended for use as an assayed quality control material. Three assayed levels of Total and Direct Bilirubin are provided.
CLINIQA LiniCAL™ Bilirubin Calibration Verifiers Levels A – E for Olympus AU Systems™ are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems™ for Total and Direct Bilirubin at five useful concentrations.
CLINIQA Liquid QC™ Bilirubin Controls Levels 1, 2 & 3 are intended for use as an assayed quality control material. Three assayed levels of Total and Direct Bilirubin are provided.
CLINIQA LiniCAL™ Bilirubin Calibration Verifiers Levels A – E for Olympus AU Systems™ are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems™ for Total and Direct Bilirubin at five useful concentrations.
The provided text is a 510(k) premarket notification approval letter for CLINIQA Liquid QC™ Bilirubin Controls Levels 1, 2 & 3 and CLINIQA LiniCAL™ Bilirubin Calibration Verifiers Levels A-E for Olympus AU Systems™.
This document does not describe a study that proves the device meets acceptance criteria in the way typically expected for an AI/CADe device or a new diagnostic tool with performance metrics like sensitivity, specificity, or AUC. Instead, this is an approval for quality control materials and calibration verifiers.
The approval for these types of devices is based on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than a clinical efficacy study with acceptance criteria and performance metrics against a ground truth in the same manner.
Therefore, many of the requested elements (e.g., sample size for the test set, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not applicable to this specific type of device and approval process.
However, I can extract the "indications for use" which define the intended function of the device.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this approval is for quality control materials and calibration verifiers based on substantial equivalence, there are no specific performance "acceptance criteria" or "reported device performance" in terms of clinical sensitivity/specificity provided in this document. The "performance" in this context is their ability to function as intended: to serve as assayed quality control materials or calibration verifiers.
| Acceptance Criteria (Implied by Indications for Use and Substantial Equivalence Determination) | Reported Device Performance (Implied by Substantial Equivalence and Approval) |
|---|---|
| CLINIQA Liquid QC™ Bilirubin Controls: Intended for use as an assayed quality control material. Three assayed levels of Total and Direct Bilirubin are provided. | The device is deemed substantially equivalent to legally marketed predicate devices for its intended use as assayed quality control material for Total and Direct Bilirubin. |
| CLINIQA LiniCAL™ Bilirubin Calibration Verifiers: Assayed, liquid, quality control products used to evaluate the performance of the Olympus AU Systems™ for Total and Direct Bilirubin at five useful concentrations. | The device is deemed substantially equivalent to legally marketed predicate devices for its intended use as assayed, liquid, quality control products to evaluate Olympus AU Systems™ performance for Total and Direct Bilirubin at five concentrations. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The approval is not based on a clinical test set in the conventional sense for diagnostic performance. Substantial equivalence typically relies on comparing the device's characteristics (e.g., formulation, intended use, manufacturing process) to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth in the clinical diagnostic sense is not established for this type of device's approval.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication method described.
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/CADe device, and no MRMC study was conducted or is relevant to this approval.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For quality control materials, ground truth would refer to the traceable values of the analytes themselves, established through reference methods and certified reference materials, rather than clinical outcomes or expert consensus on patient cases. However, this level of detail regarding the establishment of values for the controls/calibrators is not part of the 510(k) summary provided. The approval is for the product's function as a control/verifier based on substantial equivalence.
8. The sample size for the training set:
- Not Applicable. No training set is relevant for this type of device approval.
9. How the ground truth for the training set was established:
- Not Applicable. No training set is relevant for this type of device approval.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.