(132 days)
The ACCU-CHEK® Aviva system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring blood glucose in the home or health care facility. The device is indicated for professional use and over-the-counter sale. Professionals may use the test strips to test capillary and venous blood samples; lay use is limited to capillary whole blood testing. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.
The ACCU-CHEK Aviva system utilizes reagent test strips stored within a desiccated vial. A test strip is removed from the vial and inserted into the meter. Upon insertion, the meter is activated. Blood is applied to the end of the test strip, and a glucose result is reported. The test principle is: Blood from the test site works with the chemicals in the test strip to make a small electrical current in the test strip. The meter reads the current and gives the blood glucose result.
Acceptance Criteria and Device Performance Study for ACCU-CHEK® Aviva System
This document describes the acceptance criteria and the study that demonstrates the ACCU-CHEK® Aviva System meets these criteria, based on the provided FDA 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria in the typical "pass/fail" format often seen for performance studies. Instead, it focuses on demonstrating substantial equivalence to a predicate device (ACCU-CHEK Advantage system, K010362 and K032552) through similarities and highlighted differences which represent technological advancements and improved features. The "reported device performance" is inferred from the described benefits and technological improvements that are inherently tied to performance.
| Aspect | Acceptance Criteria (Inferred from Predicate Equivalence and Benefits) | Reported Device Performance (ACCU-CHEK Aviva) |
|---|---|---|
| Intended Use | Quantitatively measure glucose in capillary whole blood for persons with diabetes or healthcare professionals for home/facility monitoring. | Meets this criterion; indicated for professional use and over-the-counter sale. Professionals can test capillary and venous blood, lay users are limited to capillary whole blood. Testing sites include fingertip, palm, forearm, upper arm, thigh, and calf. |
| Sample Type | Utilize whole blood samples (capillary or venous). | Utilizes whole blood samples (capillary or venous for professionals, capillary only for lay users). |
| Operating Environment | Suitable for home and professional use. | Intended for use in the home or healthcare facilities. |
| Closed System | Test strips and controls designed for use only with the specific system. | Test strips and controls are designed to be used only with the ACCU-CHEK Aviva system. |
| Test Strip Storage | Store at room temperature, less than 90°F. Do not freeze. | Same storage conditions: room temperature, less than 90°F. Do not freeze. |
| Quality Control Procedure | Defined procedure for when to test quality controls. | Same quality control procedure: when cap is left off vial, new vial opened, meter dropped, result doesn't agree with user's feeling, or to check system performance. |
| Reportable Range | 10 – 600 mg/dL. | Same reportable range: 10 – 600 mg/dL. |
| Warnings and Precautions | For in vitro diagnostic use only. | For in vitro diagnostic use only. |
| Monitor Coding Process | Use a code key, included in test strip vial, inserted into the meter. | Uses a code key, included in the test strip vial, inserted into the meter. |
| Test Strip Packaging | Provide test strips in a desiccated vial. | Provides test strips in a desiccated vial. |
| Identification of Control | Implicitly, a reliable method for distinguishing controls from blood samples. (Predicate: Manual flagging) | Automatically distinguishes control solutions from whole blood samples, improving usability and reducing user error compared to the predicate. |
| Test Sample Volume | Implicitly, a practical and sufficient volume. (Predicate: 4.0 uL) | Requires 0.6 uL, a significant reduction from the predicate's 4.0 uL, indicating improved efficiency and potentially less discomfort for the user. |
| Test Time | Implicitly, a reasonable time for results. (Predicate: 26 seconds) | Provides results in 5 seconds, a substantial reduction from the predicate's 26 seconds, enhancing user convenience. |
| Test Strip Expiration | Implicitly, clear information regarding expiration. (Predicate: Labeling only) | Code key contains expiration date, and the system informs the user when the code key has expired, providing an additional fail-safe against using expired strips, an improvement over the predicate's labeling-only notification. |
| Test Strip Technology | Implicitly, a robust and accurate measurement principle. (Predicate: Electrical biamperometry) | Utilizes both AC/DC electrical impedance information, which is described as a new technology allowing for several fail-safes. This implies improved accuracy and reliability compared to the predicate's electrical biamperometry. |
| Blood Glucose Range Labeling | Provide appropriate guidance on normal blood glucose ranges. | Provides updated labeling instructions for normal fasting (74-106 mg/dL) and post-meal ( |
§ 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.