(46 days)
For the rapid,semi-quantitative determination of microalbuminuria. For In Vitro diagnostic use. For early detection and monitoring of the course of incipient nephropathy in diabetics and early detection and monitoring of hypertension.
Not Found
The provided document is a 510(k) summary for the DCLare™ ImmunoDip™ Stick for Microalbuminuria, indicating the FDA's determination of substantial equivalence. This type of document typically focuses on regulatory clearance and does not contain detailed information about the acceptance criteria and the comprehensive study design that would prove a device meets those criteria in the way a clinical trial report or a performance study summary would.
Therefore, the document does not contain the information requested to complete the table and answer the specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The document states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976... A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820)..."
This indicates that the device was cleared based on its substantial equivalence to a predicate device, rather than through a detailed demonstration against a set of predefined acceptance criteria through a specific study described in this letter. To find such information, one would typically need to consult the original 510(k) submission, which is not publicly available in its entirety in this format.
§ 862.1645 Urinary protein or albumin (nonquantitative) test system.
(a)
Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.