(157 days)
The SPIFE Alkaline Hemoglobin system is intended for the qualitative and semi-quantitative determination of abnormal hemoglobins using agarose electrophoresis on the SPIFE Analyzer. The system is used as a screening method for in vitro diagnostic use.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter for the SPIFE Alkaline Hemoglobin Kit, indicating that the FDA has found the device substantially equivalent to a legally marketed predicate device.
The letter itself does not include:
- A table of acceptance criteria or reported device performance.
- Information on sample sizes for test or training sets, nor data provenance.
- Details on the number or qualifications of experts, or adjudication methods for ground truth.
- Whether MRMC or standalone studies were performed, or any associated effect sizes.
- The type of ground truth used.
Essentially, this document is the outcome of a regulatory review, not the detailed study report or performance data that would have been submitted as part of the 510(k) application. To answer your questions, I would need a different type of document, such as the full 510(k) submission or a peer-reviewed publication detailing the device's validation studies.
§ 864.7440 Electrophoretic hemoglobin analysis system.
(a)
Identification. An electrophoretic hemoglobin analysis system is a device that electrophoretically separates and identifies normal and abnormal hemoglobin types as an aid in the diagnosis of anemia or erythrocytosis (increased total red cell mass) due to a hemoglobin abnormality.(b)
Classification. Class II (performance standards).