(80 days)
The Accu-Chek Advantage and Accu-Chek Advantage H Test Strips are to be used with the Accu-Chek® Advantage® and Accu-Chek® Complete™ Monitors. The Accu-Chek Advantage and Accu-Chek Complete monitors are designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities.
Professionals may use the test strips to test capillary, venous, arterial and neonate (including cord) blood samples; lay use is limited to capillary blood testing.
The Accu-Chek Advantage and Accu-Chek Advantage H Test Strips are to be used with the Accu-Chek® Advantage® and Accu-Chek® Complete™ Monitors. The test strips are designed for convenient, confident, and accurate testing of blood glucose in whole blood samples.
The provided text is a 510(k) summary for the Accu-Chek Advantage and Accu-Chek Advantage H Test Strips. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through a clinical trial with acceptance criteria for a new device.
Therefore, the document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria in the way a traditional clinical trial report would.
Here's why the requested information cannot be extracted from this document:
- 510(k) Submissions Focus on Substantial Equivalence: The primary goal of a 510(k) is to convince the FDA that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves demonstrating similar technological characteristics and intended use, and that any differences do not raise new questions of safety or effectiveness. It's not typically a full-scale clinical trial proving efficacy against pre-defined performance metrics for a novel technology.
- Lack of Performance Data: While the document mentions the device is "designed for convenient, confident, and accurate testing," it does not provide any specific numerical performance data (e.g., accuracy, precision, sensitivity, specificity, or bias) that would be compared against acceptance criteria.
- No Mention of Study Design: There is no description of a study design, sample sizes, ground truth establishment, or expert adjudication as would be found in a clinical study report. The closest it comes to a "study" is the explanation of changing the reference curve to reflect plasma glucose values, but no data from this modification is presented.
Based on the provided text, I cannot complete the table or answer the questions as the information is not present.
The document states:
- "The modified Boehringer Mannheim Accu-Chek Advantage and Accu-Chek Advantage H Test Strips are substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Accu-Chek Advantage Test Strip (K951887 and K954833)."
- "Boehringer Mannheim has modified the reference curve employed within the code key used with the Accu-Chek Advantage and Accu-Chek Advantage H test strips to now provide results which reflect the higher laboratory plasma glucose value."
This indicates a modification to an existing device (the "predicate device") to report plasma equivalent glucose values instead of whole blood equivalent values. The substantial equivalence argument relies on the predicate device's existing clearance and the technical justification for the change, not on a new, comprehensive clinical performance study with explicit acceptance criteria provided in this summary.
To get the requested information, one would need to consult the original 510(k) submissions for the predicate devices (K951887 and K954833) or a more detailed technical report for the Accu-Chek Advantage and Accu-Chek Advantage H Test Strips, which is not included in this extract.
§ 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.