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510(k) Data Aggregation
(40 days)
In vitro test for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid (CSF) on COBAS INTEGRA systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia.
The cassette COBAS INTEGRA Glucose HK New Formulation contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA SYSTEMS for the quantitative determination of glucose in serum, plasma, urine, and cerebrospinal fluid (CSF). The test principle is an enzymatic reference method with hexokinase.
Here's a breakdown of the acceptance criteria and the study details for the COBAS INTEGRA Glucose HK Gen. 3 device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device by comparing performance characteristics. Explicit "acceptance criteria" against numerical targets are not clearly defined in the provided text as separate from the performance data. Instead, the "acceptance" is implied by demonstrating that the new formulation's performance is similar to or improved compared to the predicate device's performance.
However, based on the comparative tables provided, we can infer the desired performance characteristics for the new device. The predicate device's performance effectively serves as the benchmark.
| Acceptance Criteria (Implied from Predicate) | Reported Device Performance (COBAS INTEGRA Glucose HK New Formulation) |
|---|---|
| Precision (Serum and Plasma): | |
| Within run CV%: 1.7% @ 5.3 mmol/L | Within run CV%: 1.8% @ 4.54 mmol/L |
| Within run CV%: 0.72% @ 33.2 mmol/L | Within run CV%: 1.6% @ 13.5 mmol/L |
| Between run CV%: 2.6% @ 5.3 mmol/L | Between run CV%: 2.1% @ 4.54 mmol/L |
| Between run CV%: 1.5% @ 33.2 mmol/L | Between run CV%: 2.0% @ 13.5 mmol/L |
| Precision (Urine Application): | |
| Within run CV%: 1.7% @ 1.7 mmol/L | Within run CV%: 1.2% @ 1.63 mmol/L |
| Within run CV%: 1.8% @ 37.1 mmol/L | Within run CV%: 1.1% @ 16.3 mmol/L |
| Between run CV%: 4.3% @ 1.7 mmol/L | Between day CV%: 1.2% @ 1.63 mmol/L |
| Between run CV%: 2.9% @ 37.1 mmol/L | Between day CV%: 1.1% @ 16.3 mmol/L |
| Precision (CSF Application): | |
| Within run CV%: 1.6% @ 1.7 mmol/L | Within run CV%: 0.87% @ 3.43 mmol/L |
| Within run CV%: 1.8% @ 3.3 mmol/L | Within run CV%: 1.3% @ 1.72 mmol/L |
| Between run CV%: 2.3% @ 1.7 mmol/L | Between run CV%: 0.91% @ 3.43 mmol/L |
| Between run CV%: 1.9% @ 3.3 mmol/L | Between run CV%: 1.4% @ 1.72 mmol/L |
| Lower Detection Limit: | |
| Serum and plasma: 0.033 mmol/L | Serum, plasma, urine and CSF: 0.03 mmol/L |
| Urine application: 0.22 mmol/L | (Covered by combined 0.03 mmol/L) |
| CSF application: 0.023 mmol/L | (Covered by combined 0.03 mmol/L) |
| Interferences (Endogenous): | |
| Hemolysis: No significant interferences | Same |
| Icterus: No significant interferences | Same |
| Lipemia: No significant interferences | Same |
| Gammopathy (IgM): May cause unreliable results in rare cases | In rare cases gammopathy, in particular type IgM (Waldenstrom's macroglobulinemia) may cause unreliable results. |
| Interferences (Exogenous): | |
| Pyruvates: Falsely low results may be caused by elevated levels | (Not specifically mentioned for new formulation, but assumed comparable unless stated otherwise due to "same" comparisons) |
| Measuring Range: 0-40 mmol/L (0-720 mg/dL) | 0-40 mmol/L (0-720 mg/dL) |
| Extended Measuring Range: 0-400 mmol/L (0-7200 mg/dL) with 10x dilution | 0-400 mmol/L (0-7200 mg/dL) with 10x dilution |
| Stability: Same as predicate | Same as predicate |
2. Sample Size for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes used for the precision and lower detection limit studies. It presents the results of these studies but doesn't detail the number of replicates or individual samples.
- Test Set Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's a 510(k) submission for a diagnostic kit, the studies would typically be prospective and conducted in a controlled laboratory environment to generate the performance data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device (in vitro diagnostic reagent system). The "ground truth" for a glucose test is established by comparison to recognized reference methods (e.g., enzymatic reference method with hexokinase, which is the principle of both the predicate and new device, and traceability to isotope standards). It does not involve expert consensus on pathological images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable as there is no human interpretation or subjective assessment involved that would require an adjudication method. The device provides quantitative measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study is typically performed for imaging devices or AI-assisted diagnostic tools where human readers are interpreting results, and the AI's impact on their performance is being evaluated. This device is an in vitro diagnostic reagent system for quantitative measurement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance data presented (precision, lower detection limit) are standalone performance characteristics of the assay itself, independent of human interpretation or intervention in the measurement process beyond standard laboratory procedures for running the test. The "algorithm" here refers to the chemical and enzymatic reactions and the instrument's measurement capabilities.
7. The Type of Ground Truth Used
The ground truth for evaluating the performance of this glucose test is based on:
- Reference Methods: The device itself uses an "enzymatic reference method with hexokinase," which is a highly standardized and accepted method for glucose determination.
- Traceability: The device is "Standardized against Isotope." This indicates traceability to a fundamental, highly accurate measurement standard, which forms the ultimate "ground truth" for chemical concentration.
- Comparison to Predicate: A significant part of the submission relies on demonstrating substantial equivalence through direct comparison of performance characteristics (precision, detection limits, interferences) against a legally marketed predicate device, whose "ground truth" establishment would have followed similar principles.
8. The Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning or artificial intelligence models. This device is an in vitro diagnostic reagent system based on established chemical and enzymatic reactions. Therefore, there is no "training set" in the AI sense.
However, the development and optimization of such a diagnostic reagent would involve extensive R&D, including testing with numerous samples during formulation and assay development to fine-tune reagent concentrations, reaction conditions, and ensure stability and performance across different sample types and glucose concentrations. The document does not specify the number of samples used in this developmental or "training" phase.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI/ML device, this question is not applicable. The "ground truth" for optimizing the chemical formulation and performance during development would rely on similar principles as described in point 7: comparisons to known glucose concentrations, reference methods, and established analytical performance metrics.
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