(118 days)
The QuickVue Advance pH and Amines gll test contains two colorimetric tests intended for the qualitative detection of elevated vaginal fluid pH (pH ≥ 4.7) and the presence of volatile vaginal fluid amines. The test is intended for use by health care professionals as an aid in the diagnosis of bacterial vaginosis.
The QuickVue Advance pH and Amines gll test contains two qualitative, colorimetric tests for use in the characterization of a vaginal fluid sample: (1) a pH test that differentiates vaqinal fluid pH 4.7; and (2) a test that detects alkali volatilizable amines in vaginal fluid. The test is intended for use by health care professionals as an aid in the diagnosis of bacterial vaginosis.
Here's a breakdown of the acceptance criteria and study information for the QuickVue® Advance pH and Amines gll test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| pH Test: | |
| Differentiates vaginal fluid pH 4.7 | pH test produces a distinct greenish-blue plus sign against a yellow background and a greenish-blue procedural control dot for pH ≥ 4.7. For pH |
§ 862.1550 Urinary pH (nonquantitative) test system.
(a)
Identification. A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.(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.