(583 days)
For use by professionals and people with diabetes for the quantitative determination of glucose in whole blood.
The Instant™ Test Strip, when used as directed with either the Accu-Chek® InstantPlus or Instant DM Monitor, will accurately measure the blood glucose value. The strip changes color as it reacts to glucose in a drop of blood, and the monitor measures this color change. The monitor displays the blood glucose result.
Here's an analysis of the provided text, focusing on the requested information regarding acceptance criteria and device performance.
Based on the provided snippets, the device is the Instant™ Test Strip used with Accu-Chek® InstantPlus or Instant DM Monitor, and it's being compared to the Accu-Chek® Easy™ System. The context is a 510(k) premarket notification, which typically focuses on demonstrating substantial equivalence to a predicate device rather than exhaustive clinical trials to establish new performance benchmarks. As such, the information you're looking for might not be as detailed as for a novel device.
1. Table of Acceptance Criteria and Reported Device Performance
It's important to note that the provided text does not explicitly state specific numerical acceptance criteria for accuracy (e.g., "95% of readings within ±X% of reference"). Instead, it claims substantial equivalence to a predicate device, implying that the performance is considered acceptable if it matches or is within acceptable limits compared to the predicate.
Given the available information, here's a table based on what can be inferred:
| Acceptance Criterion (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Instant™ System) |
|---|---|
| Ability to accurately measure blood glucose value | "The Instant™ Test Strip, when used as directed with either the Accu-Chek® InstantPlus or Instant DM Monitor, will accurately measure the blood glucose value." |
| Mechanism for blood glucose measurement | "The strip changes color as it reacts to glucose in a drop of blood, and the monitor measures this color change. The monitor displays the blood glucose result." |
| Intended Use (for professionals and people with diabetes for quantitative glucose determination in whole blood) | Matched (explicitly stated: "For use by professionals and people with diabetes for the quantitative determination of glucose in whole blood.") |
| Test Procedure (applying capillary blood sample to dry chemistry test strip) | Matched (explicitly stated for Accutrend and Accu-Chek Easy: "Both systems are used to measure glucose in whole blood. The procedure for both tests entails applying a capillary blood sample to a dry chemistry test strip.") |
| Non-wipe technology | Matched (explicitly stated for Accutrend and Accu-Chek Easy: "Both test system utilize non-wipe technologies.") |
| Glucose oxidase reaction | Matched (explicitly stated for Accutrend and Accu-Chek Easy: "The glucose oxidase reaction is measured in both tests.") |
| Lot-specific coding for test strips | Matched (explicitly stated for Accutrend and Accu-Chek Easy: "Both test systems have lot-specific coding for each lot of test strips.") |
| Cleared for home use | Matched (explicitly stated for Accutrend and Accu-Chek Easy: "Finally, both the Accutrend GC and Accu-Chek Easy systems are blood glucose monitoring devices which have been cleared specially for home use.") |
Key Observation: The document heavily relies on the statement "We claim equivalence to Boehringer Mannheim Corporation's Accu-Chek® Easy™ System" and then describes shared characteristics, implying that if these characteristics and the underlying methodology are similar, the performance will also be similar and acceptable. There are no quantitative performance metrics (e.g., mean absolute relative difference, specific % agreement within a certain range) provided in these snippets.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify any sample size for a test set (e.g., number of patients or blood samples). It also does not mention the provenance of any data (e.g., country of origin, retrospective or prospective). This type of detail is typically found in the study report itself, which is not fully included here.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The provided text does not mention any experts used to establish ground truth. For glucose meters, ground truth is typically established by laboratory reference methods, not by expert consensus on visual interpretation.
4. Adjudication Method for the Test Set
Since no specific test set or assessment by experts is described, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is relevant for medical devices that require human interpretation of images or other subjective data. Blood glucose monitoring systems are not typically evaluated using MRMC studies because they provide objective numerical readings. Therefore, the text does not mention an MRMC study, nor would one be expected for this type of device.
6. Standalone (Algorithm-Only) Performance Study
The device is an integrated system (test strip + monitor). While the monitor contains an "algorithm" to interpret the color change, the performance is always considered in the context of the entire system (Instant™ Test Strip + Accu-Chek® InstantPlus or Instant DM Monitor). There is no mention of a standalone algorithm-only performance study separate from the full device. It's an automatic reading device, so "human-in-the-loop" is about user operation, not interpretation.
7. Type of Ground Truth Used
The text does not explicitly state the type of ground truth used for any validation. For blood glucose meters, the ground truth is typically established using a laboratory reference method (e.g., YSI analyzer, hexokinase method) which is considered highly accurate. The absence of specific study details means this information is not available in the given snippets.
8. Sample Size for the Training Set
The provided text does not mention a training set sample size. For a traditional 510(k) submission asserting substantial equivalence, the focus is often on verifying the new device's performance against the predicate, not necessarily retraining or newly training a complex algorithm.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, there is no information on how its ground truth was established. If there were any internal algorithms requiring training, the ground truth would typically be established against highly accurate laboratory reference methods.
In summary, the provided document is a summary of safety and effectiveness for a 510(k) submission. It focuses on establishing substantial equivalence by describing the device's intended use and operating principles in comparison to a predicate device. It lacks the detailed quantitative performance metrics, study design specifics, sample sizes, and ground truth methodologies that would be provided in a full clinical or validation study report.
§ 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.