(35 days)
The Glucose assay is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the ALCYON 300/300i Analyzer. 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.
Glucose is an in vitro diagnostic assay for the quantitative determination of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF). The Glucose assay is a clinical chemistry assay in which glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PD) specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD) to nicotinamide adenine dinucleotide reduced (NADH). One micromole of NADH is produced for each micromole of glucose consumed. The NADH produced absorbs light at 340 nm and can be detected spectrophotometrically as an increased absorbance.
The provided document describes a 510(k) submission for the Abbott Laboratories Glucose assay. This assay is an in vitro diagnostic (IVD) test, not a medical device in the typical sense of imaging or interventional tools, and as such, the acceptance criteria and study design will differ significantly from what would be expected for a device like an AI-powered diagnostic image analysis system.
The document does not contain acceptance criteria or study details in the format requested for a typical AI/medical device study. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices.
Here's a breakdown based on the information available and what is not present:
Missing Information:
The document does not provide specific numerical acceptance criteria (e.g., sensitivity, specificity, AUC) or detailed study designs with sample sizes, expert qualifications, or ground truth establishment methods for a de novo performance study. This is because the submission's goal is to show equivalence.
Based on the provided K981185 510(k) Summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Expected/Implied) | Reported Device Performance |
|---|---|
| Clinical Results: Similar to predicate devices | "Both assays yield similar clinical results." (compared to Roche) |
| "Both assays yield similar clinical results." (compared to Boehringer Mannheim) | |
| Methodology: In vitro clinical chemistry method | "Both assays are in vitro clinical chemistry methods." (compared to Roche and Boehringer Mannheim) |
| Intended Use: Quantitative determination of glucose | "Both assays can be used for the quantitative determination of glucose." (compared to Roche and Boehringer Mannheim) |
| Assay Range: Comparable to predicate devices | "There is a minor difference between the assay range." (compared to Roche and Boehringer Mannheim) |
Explanation: For an IVD assay seeking substantial equivalence, the "acceptance criteria" are implicitly met if the new device performs "similarly" to a legally marketed predicate device across key performance characteristics and intended use. The document states that the new Glucose assay yields "similar clinical results" and utilizes "similar clinical chemistry methods" to its predicates. The "minor difference between the assay range" is acknowledged but not presented as a significant deviation from equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document describes a general comparison to predicate devices, but no specific sample size for a "test set" from a performance study is provided.
- Data Provenance: Not explicitly stated. This would typically involve details on study populations (e.g., patient demographics, disease prevalence) and whether the data was collected retrospectively or prospectively. Given it's a 1998 submission for an assay, it's highly likely internal validation data was used, but the specifics are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable / Not provided. For an IVD assay like this, "ground truth" is typically established by reference methods or clinical diagnosis, not by experts adjudicating visual data as in an AI imaging study. No information on experts or their qualifications is present.
4. Adjudication Method for the Test Set:
- Not applicable / Not provided. Adjudication methods (like 2+1, 3+1) are common in AI imaging studies where human disagreement needs resolution. For a quantitative IVD assay, ground truth is usually a measured value, and adjudication in this sense is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- Not applicable. This study is for a standalone in vitro diagnostic assay, not an AI-assisted diagnostic tool that would be used by human readers. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, implicitly. The device is a standalone assay. Its performance is evaluated independently as a chemical reaction observed spectrophotometrically. The "algorithm" here is the chemical reaction and spectrophotometric measurement, not a software algorithm in the AI sense. Its performance is "standalone" in that it directly measures glucose levels.
7. The Type of Ground Truth Used:
- Clinical results compared to predicate assays. The document states "Both assays yield similar clinical results" when compared to the Roche Cobas Mira Plus Glucose assay and the Boehringer Mannheim Glucose/HK assay. For an IVD, the ground truth would typically be established by a well-accepted reference method or another clinically validated method that is considered a gold standard for glucose measurement. While not explicitly stated, the implication is that the predicate assays served as the comparative "truth" for demonstrating similar performance, likely against a broader clinical context of diagnosed conditions.
8. The Sample Size for the Training Set:
- Not applicable / Not provided. This is an IVD assay based on a pre-defined chemical reaction, not a machine learning algorithm that requires a "training set" in the AI sense. The assay is "trained" by its chemical formulation and calibration, not by data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable / Not provided. As mentioned above, there isn't a "training set" or "ground truth for a training set" in the context of this chemical assay. The assay's performance characteristics (e.g., linearity, precision, accuracy) would have been established through standard IVD validation procedures using calibrated materials and patient samples, but these are not equivalent to AI training data.
Summary of Limitations based on the provided document:
The provided document is a 510(k) summary focused on establishing substantial equivalence for an in vitro diagnostic assay. It is not a detailed clinical study report for an AI-powered medical device. Therefore, many of the requested categories (e.g., sample size for test set/training set, expert qualifications, MRMC study, ground truth for training set) are either not applicable or not explicitly detailed within the scope of this specific type of regulatory submission. The "study" described is a comparison of performance characteristics and intended use to existing, legally marketed predicate devices, rather than a de novo clinical trial with specific performance endpoints.
§ 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.