(75 days)
The Cholinesterase Gen.2 Test System is an in vitro test for the quantitative determination of the catalytic activity of cholinesterase (EC 3.1.1.8; acylcholine acylhydrolase) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders.
The Cholinesterase Gen.2 Test System is an in vitro test for the quantitative determination of the catalytic activity of cholinesterase in serum and plasma. The test is based on the butyrylthiocholine method. Cholinesterase catalyzes the hydrolysis of butyrylthiocholine to thiocoline and butyrate. Thiocholine reduces the yellow substrate hexacyanoferrate III to the almost colorless hexacyanoferrate II. The decrease in color is measured spectrophotometrically. The calibrator is the Calibrator for automated systems (C.f.a.s; and the recommended control materials are Precinorm U or Precinorm U Plus; and Precipath U or Precipath U plus.
The provided text describes the Cholinesterase Gen.2 test system, a device for in vitro quantitative determination of cholinesterase catalytic activity. The submission compares this new device to a predicate device (Cholinesterase Test System, K951595) to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than explicit "acceptance criteria" against pre-defined performance goals for a new medical device. However, performance characteristics are presented, which implicitly serve as the basis for demonstrating equivalence.
| Performance Characteristic | Acceptance Criteria (Implicit - from Predicate Device) | Reported Device Performance (Cholinesterase Gen.2 Test System) |
|---|---|---|
| Measuring Range | 0 - 25000 U/L | 200 - 14000 U/L (Extended range after postdilution: 200 - 28000 U/L) |
| Lower Detection Limit | 4.5 U/L | 200 U/L |
| Within-run Precision (%CV) | 1.0% at 1728 U/L; 0.99% at 9545 U/L | 0.5% at 6374 U/L; 0.6% at 6263 U/L; 0.6% at 6015 U/L |
| Between-run Precision (%CV) | 2.2% at 1728 U/L; 1.8% at 9545 U/L (total CV) | 1.4% at 6374 U/L; 1.1% at 6263 U/L; 0.9% at 6015 U/L |
| Method Comparison (Correlation to Predicate) | (Implied acceptable correlation) | y = Integra Cholinesterase Gen.2; x = Integra cholinesterase (granulate); Passing-Bablok results: y=0.970x + 128. T = 0.967; r = 0.999 |
| Limitations/Interferences | No significant interference from hemolysis, icterus, lipemia; Citrate and fluoride inhibit reaction; Propanolol causes artificially low values; High albumin increases activity. | No significant interference from bilirubin; No significant interference up to H index of 350, L index of 1000; Citrate and fluoride inhibit reaction; No significant interference from tested drugs; Rare cases of monoclonal gammopathy (IgM) may cause unreliable results. |
| Reagent Stability (On board analyzer) | 8 weeks | 4 weeks |
Study Proving Device Meets Acceptance Criteria:
The "study" refers to the entire submission and the performance data presented within it, which are used to show the new device is substantially equivalent to the predicate. The "Method comparison" section specifically details a direct comparison study.
2. Sample size used for the test set and the data provenance
The sample size for the method comparison (test set) is not explicitly stated. The provenance of the data (country of origin, retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The study compares the performance of two in vitro diagnostic devices measuring an analyte, not an interpretation of images or clinical diagnoses by human experts.
4. Adjudication method for the test set
This information is not applicable and not provided. The study involves quantitative measurements by automated systems, not subjective assessments requiring adjudication.
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
This information is not applicable. This is an in vitro diagnostic device for quantitative measurement, not an AI-assisted diagnostic imaging device or an interpretation task by human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The context is an in vitro diagnostic test system, which inherently operates as a standalone algorithm/system to produce a quantitative result. The results are then used by a human clinician for diagnosis and treatment. The performance metrics reported (precision, measuring range, detection limit, method comparison) represent the standalone performance of the Cholinesterase Gen.2 Test System.
7. The type of ground truth used
The "ground truth" for this type of quantitative diagnostic device is established by comparison to a reference method or a legally marketed predicate device, and through fundamental analytical validation methods.
- For Method Comparison: The predicate device ("Integra cholinesterase (granulate)") serves as the comparative standard.
- For Traceability/Standardization: The device is "Standardized against a reference method using a manual application of the butyrylthiocholine/hexacyanoferrate (III) method on a photometer and the published molar absorptivity of hexacyanoferrate (III)." This manual reference method acts as a form of ground truth for calibration and accuracy.
8. The sample size for the training set
This information is not provided. For this type of IVD, a "training set" in the machine learning sense is not typically applicable. Development involves optimizing reagents and analytical conditions, and validation involves characterizing performance.
9. How the ground truth for the training set was established
This information is not applicable as there is no mention of a "training set" in the context of an AI/ML algorithm. The "standardization" and "traceability" sections describe how the device's measurements are referenced to established analytical methodologies.
§ 862.3240 Cholinesterase test system.
(a)
Identification. A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.