(74 days)
The Dade Behring Dimension® Lidocaine (LIDO) Flex® reagent cartridge method on the Dimension® clinical chemistry system is for the quantitative determination of lidocaine in serum or plasma. Lidocaine measurements may be used in the diagnosis and treatment of lidocaine overdose and in therapeutic drug monitoring.
The Dade Behring Dimension® Drug Calibrator II (DC49D) is a device intended for medical purposes for use on the Dimension® clinical chemistry system to establish points of parfonob to are used in determination of values in the measurement of substances in human specimens.
Method: The Dade Behring Dimension® Lidocaine (LIDO) Flex® reagent cartridge method is an in vitro diagnostic test that consists of prepackaged reagents in a flexible plastic cartridge for use only on the Dimension® clinical chemistry system. The Dimension® LIDO Flex® reagent cartridge assay is based on a homogenous particle-enhanced turbition immunoassay (PETINIA) which uses a latex particle-lidocaine conjugate and monoclonal lidocaine specific antibody. Lidocaine present in the sample competes with lidocaine on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of lidocaine in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm.
Calibrator: The Dade Behring Drug Calibrator 11 (DC49D) is liquid, bovine serum base product, packaged as ten vials to a carton, with two vials at each of five levels; each vial contains 5.0 mL. This same product, the Dade Behring Drug Calibrator II (DC49C), was previously cleared (K032574) for calibration of its associated methods on the Dimension® clinical chemistry system. The product remains unchanged except for the additional value assignment for the Lidocaine constituent.
Here's a breakdown of the acceptance criteria and the study details based on the provided text, formatted to address your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are implicitly met by showing good agreement with the predicate. The performance is reported as a comparison to this predicate.
| Feature / Metric | Acceptance Criteria (Implicitly met by demonstrating substantial equivalence to predicate) | Reported Device Performance (Dimension® LIDO Flex® vs. aca® LIDO) |
|---|---|---|
| Correlation Coefficient | High correlation (implicitly accepted as equivalent to predicate) | 0.99 |
| Slope | Close to 1.0 (implicitly accepted as equivalent to predicate) | 0.985 |
| Intercept | Close to 0 (implicitly accepted as equivalent to predicate) | -0.037 ug/mL |
| Intended Use | In vitro diagnostic use for quantitative determination of lidocaine in serum or plasma, used for diagnosis/treatment of overdose and therapeutic drug monitoring. | Matches predicate. |
| Assay Range | Comparable to predicate. | 0.5 - 12.0 ug/mL (Predicate: 1.0 - 12.0 ug/mL) - Note: The new device has a slightly wider lower range. |
| Sample Size (of assay) | Comparable to predicate. | 6 µL (Predicate: 40 µL) - Note: The new device uses a significantly smaller sample size. |
| Measurement Technology | Immunoassay method. | PETINIA (Turbidimetric rate at 340 nm and 700 nm) (Predicate: EMIT®, Colorimetric rate at 340 nm) - Note: Different but both immunoassay principles. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: 120 (for the split-sample comparative performance).
- Data Provenance: Not explicitly stated (e.g., country of origin). The data is from a "split-sample comparative performance" study, which by its nature is a prospective comparison of the new device against the predicate on the same samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This study did not involve establishing a ground truth through expert consensus. Instead, it compared the new device's measurements directly against those of a legally marketed predicate device. The predicate device's measurements served as the comparative standard.
4. Adjudication Method for the Test Set
Not applicable. As the study is a direct comparative measurement against a predicate, there was no need for adjudication by experts.
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 is a study for an in vitro diagnostic (IVD) device (a laboratory test for measuring a substance in a sample), not an imaging or AI-assisted diagnostic device involving human readers or interpretation of medical cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The "Dimension® Lidocaine (LIDO) Flex® reagent cartridge method" is an automated in vitro diagnostic assay. Its performance (accuracy, precision, linearity, etc.) is evaluated inherently as a standalone system. The study performed here is a "standalone" comparison of its analytical performance against another standalone analytical system (the predicate device). There is no "human-in-the-loop" component for interpretation in the context of this device.
7. The Type of Ground Truth Used
The "ground truth" for the test set was the measurements obtained from the predicate device, the Dade Behring aca® LIDO analytical test pack method (K833379). This is a "comparison to a legally marketed device" or "predicate device comparison" type of ground truth for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This medical device (an in vitro diagnostic assay and calibrator) does not utilize machine learning or AI models, and therefore does not have a "training set" in that context. The development of the reagent cartridge and its parameters would have involved various optimization studies, but these are not referred to as a "training set" in the sense of AI/ML.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" as defined for AI/ML models.
§ 862.3555 Lidocaine test system.
(a)
Identification. A lidocaine test system is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy.(b)
Classification. Class II.