(83 days)
The Exalenz BreathID® Hp System is intended for use to continually and non-invasively measure changes in the 1302 / 1202 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The Exalenz BreathID® Hp System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. The Exalenz BreathID® Hp System consists of the IDkit:Hp™ and the BreathID® Hp test device.
The device is for use by trained health care professionals. To be administered under a physician's supervision.
The modified BreathID® Hp System is a non-invasive breath test system for detecting the presence of Helicobacter pylori (H. pylori). The system consists of an electro-optical medical device with embedded software designed to measure and compute the changes in the ratio between 1302 and 1202 concentrations in the patient's exhalation and a test kit. The test kit consists of:
- IDcircuit™ Oridion Nasal FilterLine™ (nasal cannula) (K980325)
- A 75mq 13C-urea tablet
- A 4.3g package of powdered Citrica (citric acid)
- Drinking straw
- Package Insert (Instructions for Use)
The modified BreathID® Hp System measures and computes the ratio between 1302 and 1202 in the patient's exhalation before and after the ingestion of 13C-urea. The change in the 1302 / 1202 ratio before and after ingestion of 13C-urea is referred to as the Delta over Baseline (DOB).
The basis of the 13C measurement method for both the modified versions of the BreathID® System is a technology called Molecular Correlation Spectroscopy™ (MCS™), MCS™ is based on the concept of optical absorption of specific radiation emitted from CO2 discharge lamps.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core of the acceptance criteria for substantial equivalence in the clinical validation centered on the agreement between the modified BreathID® Hp System and its predicate device (unmodified BreathID® System) for H. pylori diagnosis.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Positive Percent Agreement: ≥ 95% | 100% [95% Cl (81.6, 100)] |
| Negative Percent Agreement: ≥ 95% | 97% [95% Cl (89.0, 99.1)] |
| Comparative Validation (Analytical): | |
| Pearson's Correlation Coefficient (r) | r = 0.9944 (95% Cl: [0.9904, 0.9966]) |
| p-value | p |
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).