(82 days)
System reagent for the quantitative determination of Cholinesterase activity (E.C. 3.1.1.8) in human serum and plasma on Beckman Coulter Synchron CX® Pro System(s), Synchron LX® Pro System(s) and UniCel® DxC 600/800 System(s).
Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).
System reagent for the quantitative determination of Cholinesterase activity (E.C. 3.1.1.8) in human serum and plasma on Beckman Coulter Synchron CX® Pro System(s), Synchron LX® Pro System(s) and UniCel® DxC 600/800 System(s).
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).
The method is based on the recommendations of the German Society for Clinical Chemisty (Deutsche Gesellschaft für Klinische Chemie, DGKCh).
Cholinesterase catalyses the hydrolysis of butyrytthiocholine to butyrate and thiocholine. Thiocholine reduces yellow hexacyanoferrate (III) to colorless hexacvanoferrate (II). The decrease in absorbance at 410 nm is directly proportional to the cholinesterase activity in the sample.
The provided document is a 510(k) summary for the SYNCHRON® Systems Cholinesterase (CHEX) Reagent, which is a device for measuring cholinesterase activity in human serum and plasma. This is an in vitro diagnostic device (IVD) and not an AI/ML powered medical device. Therefore, many of the requested categories for AI/ML device studies are not applicable.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The summary states that "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments." However, specific quantitative acceptance criteria or detailed performance metrics are not explicitly presented as a table in this summary. The summary highlights that key analytical characteristics are "same" as the predicate device (Olympus Cholinesterase (CHE) Assay).
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (SYNCHRON CHEX Reagent) |
|---|---|---|
| Intended Use | Same as Olympus Cholinesterase (CHE) Assay | Same (as predicate) |
| Methodology | Same as Olympus Cholinesterase (CHE) Assay | Same (as predicate) |
| Reagent Constituents | Same as Olympus Cholinesterase (CHE) Assay | Same (as predicate) |
| Fundamental Technology | Same as Olympus Cholinesterase (CHE) Assay | Same (as predicate) |
| Analytic Interval | Same as Olympus Cholinesterase (CHE) Assay | Same (as predicate) |
| Expected Values | Same as Olympus Cholinesterase (CHE) Assay | Same (as predicate) |
| Sensitivity | Same as Olympus Cholinesterase (CHE) Assay | Same (as predicate) |
| Within run precision | Same as Olympus Cholinesterase (CHE) Assay | Same (as predicate) |
| Total precision | Same as Olympus Cholinesterase (CHE) Assay | Same (as predicate) |
| LIQUID stable reagents | Same as Olympus Cholinesterase (CHE) Assay | Same (as predicate) |
| On board, open reagent stability | Same as Olympus Cholinesterase (CHE) Assay | Same (as predicate) |
| Interfering Substances | ||
| - Hemoglobin | 500 mg/dL (Predicate) | 1000 mg/dL (Improved from Predicate) |
| - Bilirubin | 40 mg/dL (Predicate) | 60 mg/dL (Improved from Predicate) |
| - Lipemia | ≤ 1000 mg/dL (Intralipid) (Predicate) | 2000 mg/dL (triglyceride) (Improved from Predicate) |
| - Ascorbic Acid | 20 mg/dL (Predicate) | 30 mg/dL (Improved from Predicate) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The experiments mentioned are "method comparison, stability, linearity, and imprecision experiments," which are typical for IVD devices, but the specifics are not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable as the device is an IVD for quantitative measurement of an enzyme. "Ground truth" in the context of expert consensus for image interpretation or diagnosis is not relevant here. The ground truth for such a device is typically established through reference methods or highly accurate analytical techniques, not expert review.
4. Adjudication Method for the Test Set
Not applicable for an IVD device measuring a quantitative biomarker.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. This is an in vitro diagnostic reagent, not an AI/ML-powered device that assists human readers in interpreting medical cases.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This is an in vitro diagnostic reagent that produces a quantitative result. Its performance is evaluated through analytical studies, not typically against human interpretation.
7. The Type of Ground Truth Used
For an IVD device like this, the "ground truth" for evaluating its performance would typically involve:
- Reference methods: Using highly accurate and established analytical methods to determine the true concentration or activity of cholinesterase in samples.
- Known concentrations: Using samples with known, spiked concentrations of cholinesterase for linearity and accuracy studies.
- Comparative methods: Comparison against a legally marketed predicate device (as indicated by the "Comparison to Predicate(s)" section). The predicate device itself serves as a standard for comparison.
8. The Sample Size for the Training Set
Not applicable. This is an IVD device, not an AI/ML device that requires a training set. Its functionality is based on biochemical reactions.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.