(322 days)
The AmniSure™ ROM (Rupture Of [fetal] Membranes) Test is a rapid, noninstrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal secretions of pregnant women. AmniSure detects PAMG-1 protein marker of the amniotic fluid in vaginal secretions. The test is for use by health care professionals to aid in the detection of ROM in pregnant women at > 34 weeks gestation when patients report signs, symptoms or complaints suggestive of ROM.
Not Found
The provided text is a 510(k) Premarket Notification from the FDA for a device called "AmniSure™ ROM (Rupture of [fetal] Membranes) Test". While it outlines the device's intended use and FDA approval, it does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria using only the information provided. The document primarily focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.
To answer your questions, I would need access to the actual study report or the detailed premarket notification submission that would contain 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.