(38 days)
The Assure 4 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
Assure 4 consists of a meter, test strips, and control solutions for use in measuring blood glucose as an aid to monitor the effectiveness of diabetes control. The Assure 4 measures electrical current generated by the interaction of glucose with glucose oxidase in its biosensor test strip. It uses a code chip for strip lot calibration.
The provided text describes the Assure 4 Blood Glucose Monitoring System and its modifications compared to the Assure 3, but does not include detailed acceptance criteria or a study proving the device meets specific performance criteria with numerical results.
The document K070088 is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting full study results against explicit acceptance criteria. While it mentions "Clinical testing was done with persons with diabetes in addition to in-house testing for precision, interferences, linearity, altitude effects, hematocrit effects, minimum sample volume, stability, control solution functionality, and temperature and humidity effects," it lacks the specific data, acceptance thresholds, sample sizes, and expert details requested.
Therefore, many of the requested fields cannot be fully populated from the provided text.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Not explicitly stated/quantified in provided text) | Reported Device Performance (Not explicitly stated/quantified in provided text) |
|---|---|---|
| Precision | Not specified | Clinical testing performed |
| Interferences | Not specified | Clinical testing performed |
| Linearity | Not specified | Clinical testing performed |
| Altitude Effects | Not specified | Clinical testing performed (up to 7,000 ft listed as a characteristic) |
| Hematocrit Effects | Not specified | Clinical testing performed (30-55% listed as a characteristic) |
| Minimum Sample Volume | Not specified, but Assure 4 changed to 1.5 µL | 1.5 µL (for Assure 4) |
| Stability | Not specified | Clinical testing performed |
| Control Solution Functionality | Not specified | Clinical testing performed |
| Temperature & Humidity Effects | Not specified | Clinical testing performed (Operating T° Range: 57-104°F, Humidity: |
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.