(422 days)
KetoSens Blood ß-Ketone Monitoring System is intended to be used for the quantitative measurement of f-Ketone (beta-hydroxybutyrate) level in capillary whole blood samples drawn from the fingertip. The KetoSens Blood B-Ketone Monitoring Systems are for self-testing outside the body (for in vitro diagnostic use) in the home as an aid to monitor the effectiveness of diabetes control program. The system is not in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system is intended to be used by a single person and should not be shared.
The KetoSens Blood ß-Ketone Test Strips work with the KetoSens Blood ß-Ketone Meter to quantitatively measure Blood ß-Ketone in capillary whole blood samples drawn from the fingertip.
KetoSens Multi Blood p-Ketone Monitoring System is intended to be used for the quantitative measurement of f-Ketone (beta-hydroxybutyrate) level in capillary whole blood from the fingertip and venous EDTA whole blood. KetoSens Multi Blood ß-Ketone Monitoring System is intended for in vitro diagnostic use and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. The system is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. This system should only be used with single-use, auto-disabling lancing devices.
The KetoSens Multi Blood p-Ketone Test Strips work with Blood ß-Ketone Meter to quantitatively measure Blood B-Ketone in capillary whole blood samples drawn from the fingertip and venous whole blood drawn in professional healthcare settings.
The KetoSens Blood ß-Ketone Monitoring System/KetoSens Multi Blood ß-Ketone Monitoring System consists of a meter, single use test strips, and control solutions with two different B-Ketone concentrations ("Control A" and "Control B" ranges).
The KetoSens Blood ß-Ketone Monitoring System/KetoSens Multi Blood ß-Ketone Monitoring System is based on an electrochemical biosensor technology (electrochemical). The System measures the Blood ß-Ketone level in whole blood samples using a small electrical current generated in the test strips.
This document focuses on the KetoSens Blood β-Ketone Monitoring System and its validation studies. It describes various performance tests conducted to ensure the device meets specified criteria, primarily focusing on accuracy, precision, and usability.
Here's an organized breakdown of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a single table labeled "Acceptance Criteria." However, acceptance criteria are implicitly stated within the "System Accuracy Test" and "Consumer Study" results, and "Repeatability Test" and "Intermediate Precision Test" conclusions.
| Test Type | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Repeatability (Precision) | Pooled SD of concentrations 1, 2 should be 0.95). | Passed. Total r² = 0.9985 across 3 strip lots. |
| System Accuracy (Capillary Blood) | At ketone At ketone At ketone ≥ 1.5 mmol/L: 33/33 (100%) within ± 20 %. | |
| All 204 samples (100%) fell within specified ranges. | ||
| System Accuracy (Venous Blood) | At ketone At ketone At ketone ≥ 1.5 mmol/L: 35/35 (100%) within ± 20 %. | |
| All 204 samples (100%) fell within specified ranges. | ||
| Consumer Study (Accuracy) | Capillary blood accuracy to satisfy system accuracy requirements (as defined above). | Passed. |
General user tests: 185/185 (100%) within ± 0.3 mmol/L (for ketone Trained user tests: 185/185 (100%) within ± 0.3 mmol/L (for ketone Capillary: 124/124 (100%) within ± 0.3 mmol/L for Venous: 121/123 (98.4%) within ± 0.3 mmol/L for
§ 862.1435 Ketones (nonquantitative) test system.
(a)
Identification. A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.(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.