(100 days)
ANEMIA CAL is an in vitro diagnostic product for the calibration of the LOCI Vitamin B12 (B12)and LOCI Folate(FOL) methods on the Dimension(r) EXI(tm) integrated chemistry system and the Ferritin(FERR) method on the Dimension(r) clinical chemistry system.
ANEMIA CAL is a multi-analyte, liquid, frozen bovine serum albumin based product containing ferritin from human liver, Vitamin B12 and Folate
The provided text describes a 510(k) summary for an "Anemia Calibrator" device. However, it does not contain any information about acceptance criteria, device performance results from a study, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
The document focuses on:
- Manufacturer and device identification: Siemens Healthcare Diagnostics, Anemia Calibrator, Class II device.
- Intended Use: Calibration of Ferritin (FERR), LOCI Vitamin B12 (B12), and LOCI Folate (FOL) methods on the Dimension® EXL™ integrated chemistry system and Dimension® clinical chemistry system.
- Substantial Equivalence: Comparison to a predicate device (Dimension Vista® LOCI 4 Calibrator), highlighting similarities (intended use, form, constituents, traceability, levels, stability) and differences (system compatibility).
- FDA Clearance Letter: Official notification of substantial equivalence determination.
Therefore, I cannot provide the requested information. The input document simply does not contain the details necessary to answer those points.
§ 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.