(22 days)
Calibrators: The ARCHITECT ® DHEA-S Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma.
Controls: ARCHITECT® DHEA-S Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma.
For in vitro diagnostic use.
Calibrators: The ARCHITECT ® DHEA-S Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma.
Controls: The ARCHITECT ® DHEA-S Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of DHEA -S in human serum and plasma.
The provided document, K060027, is a 510(k) summary for the ARCHITECT® DHEA-S Calibrators and Controls. It describes the devices and claims substantial equivalence to a legally marketed predicate device (DPC IMMULITE® DHEA-SO4). However, it does not contain the acceptance criteria or a study demonstrating that the device meets specific performance criteria.
Instead, the submission focuses on comparing the new device's technological characteristics (intended use, methodology, assay protocols, matrix) to the predicate device to demonstrate substantial equivalence. It also lists differences such as the platform, traceability, standardization, calibration range/levels, and value assignment.
The FDA's response confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. This type of submission relies on demonstrating similarity to an already approved device rather than presenting new clinical performance data against specific acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document does not include such information.
§ 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.