(52 days)
The Orion Diagnostica QuikRead CRP Verification Set is intended for verification of calibration and method validation of the QuikRead CRP System. For in vitro diagnostic use.
Not Found
This is a 510(k) premarket notification for a Class I quality control material (Orion Diagnostica QuikRead® CRP Verification Set). The provided document is an FDA clearance letter and the "Indications for Use" statement. It does not contain a study or data proving the device meets acceptance criteria.
The clearance letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. For Class I devices like this, detailed performance studies with acceptance criteria are typically not required as part of the 510(k) submission itself, as these are often well-established technologies. The focus is on demonstrating that the new device is substantially equivalent to an existing one.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: This is not present.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/present.
- Adjudication method: Not applicable/present.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable/present.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a verification set, not an algorithm.
- The type of ground truth used: Not applicable/present.
- The sample size for the training set: Not applicable/present.
- How the ground truth for the training set was established: Not applicable/present.
Summary based on the provided document:
The provided document is an FDA clearance letter for a Class I quality control material. It confirms that the Orion Diagnostica QuikRead® CRP Verification Set is substantially equivalent to predicate devices for its intended use of "verification of calibration and method validation of the QuikRead CRP System." However, the document does not include any performance study data, acceptance criteria, or details of ground truth establishment. For Class I devices, the 510(k) process primarily focuses on demonstrating substantial equivalence, rather than requiring extensive clinical performance studies that would typically involve acceptance criteria and ground truth validation as described in your request.
§ 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.