(69 days)
an in vitro diagnostic reagent test kit for the quantitative analysis of gentamicin in human serum or plasma.
modified Emit® 2000 Gentamicin Assay, an in vitro diagnostic reagent test kit for the quantitative analysis of gentamicin in human serum or plasma.
Here's an analysis of the provided text in the context of device acceptance criteria and a supporting study:
The provided document describes the Emit® 2000 Gentamicin Assay and Emit® 2000 Gentamicin Calibrators, an in vitro diagnostic reagent test kit. The study aims to demonstrate substantial equivalence to a predicate device, the Abbott TDx Gentamicin Assay (K904226).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as clear pass/fail thresholds. Instead, it presents performance metrics and implies that these values demonstrate substantial equivalence to the predicate device. Therefore, I will create a table based on the reported precision and accuracy for the Emit® 2000 Gentamicin Assay.
| Performance Metric | Acceptance Criteria (Implied/Compared to Predicate) | Reported Device Performance (Emit® 2000 Gentamicin Assay) |
|---|---|---|
| Precision | Low CVs for within-run and total precision | Within-run precision CVs: 1.6 to 5.6% |
| Total precision CVs: 2.7 to 6.7% | ||
| Accuracy (vs. Abbott TDx Gentamicin Assay) | Strong correlation (correlation coefficient close to 1) | Correlation: 0.995 |
| Slope close to 1 | Slope: 0.94 | |
| Intercept close to 0 | Intercept (ng/mL): 0.10 | |
| Low standard error of the estimate | Standard Error of the Estimate (ng/mL): 0.18 | |
| Similar mean values | Mean (ng/mL) Emit 2000 Assay: 2.706 | |
| Mean (ng/mL) FPIA Method: 2.544 |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 104 patient samples were evaluated for accuracy.
- Data Provenance: The document does not explicitly state the country of origin. It refers to "patient samples," which implies human subjects. The study is prospective in the sense that the samples were analyzed with the Emit 2000 Gentamicin Assay to compare against the predicate, but it doesn't specify if these were newly collected samples specifically for the study or retrospectively collected. The term "patient samples" often implies retrospectively collected samples from a clinical setting, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This study does not involve human experts establishing a "ground truth" in the typical sense (e.g., radiologists interpreting images). The ground truth for this comparative accuracy study is the results from the predicate device (Abbott TDx Gentamicin Assay), which is itself an analytical device. Therefore, the concepts of "number of experts" and "qualifications of experts" are not applicable here.
4. Adjudication Method for the Test Set
Not applicable. There was no human interpretation or adjudication involved, as the comparison was between two analytical devices.
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 not an AI-assisted diagnostic study involving human readers. It's a comparison of two in vitro diagnostic assays.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance assessment was conducted for the Emit® 2000 Gentamicin Assay, as described under "A. Within-Run and Total Precision" and "B. Accuracy." The device's performance was evaluated based on its own output against established reference methods (for precision) or the predicate device (for accuracy). There is no "human-in-the-loop" component in the operation or result generation of these assays.
7. The Type of Ground Truth Used
The ground truth used for the accuracy study was the results obtained from the predicate device, the Abbott TDx Gentamicin Assay (FPIA). For the precision study, commercial controls with known analyte levels would serve as a form of "ground truth" or reference material.
8. The Sample Size for the Training Set
Not applicable. This is an analytical immunoassay kit, not a machine learning model that requires a training set. The "development" and "calibration" process for such a kit involves different methodologies.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows a handwritten sequence of numbers and letters. The sequence starts with the letter 'K', followed by the numbers 9, 6, 2, 5, 1, and 9. The handwriting is in a cursive style, with some of the numbers connected to each other. The overall impression is that of a quickly written or informal note.
Image /page/0/Picture/1 description: The image shows the logo for Behring. The logo is in a rectangular box. The word "BEHRING" is in large, bold, sans-serif font at the top of the box. Below the word is a line, and below the line is the signature "S. Behring" in cursive.
SEP - 4 1996
SUMMARY OF SAFETY AND EFFECTIVENESS Emit® 2000 Gentamicin Assay and Emit® 2000 Gentamicin Calibrators
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
Behring Diagnostics Inc. is submitting this Premarket Notification, 510(k) to convey our intention to commercially distribute a modified Emit® 2000 Gentamicin Assay, an in vitro diagnostic reagent test kit for the quantitative analysis of gentamicin in human serum or plasma. The modified Emit 2000 Gentamicin Assay has been found to be substantially equivalent to the Abbott TDx Gentamicin Assay (K904226) with regard to intended use, assay sample, and overall performance characteristics.
I. PERFORMANCE STUDIES
A. Within-Run and Total Precision
Within-run and total precision for the Emit 2000 Gentamicin Assay were calculated in a manner consistent with the NCCLS EP5-T2 protocol. Precision was evaluated using three levels (subtherapeutic, therapeutic, and upper therapeutic) of commercially available controls. The results of these studies are summarized below:
Within-run precision CVs: 1.6 to 5.6%. Total precision CVs: 2.7 to 6.7%
B. Accuracy
One-hundred and four patient samples were evaluated using the Emit 2000 Gentamicin Assay on the Syva 30R Analyzer. The analysis demonstrate excellent correlation with the Abbott TDx Gentamicin Assay (FPIA). The accuracy results are summarized below:
| Slope | 0.94 |
|---|---|
| Intercept (ng/mL) | 0.10 |
| Mean (ng/mL) | |
| Emit 2000 Assay | 2.706 |
| FPIA Method | 2.544 |
| Standard Error of the | |
| Estimate (ng/mL) | 0.18 |
| Correlation | 0.995 |
| Number of Samples | 104 |
In conclusion, Behring Diagnostics considers the Emit 2000 Gentamicin Assay to be substantially equivalent to the Abbott TDx Gentamicin Assay.
§ 862.3450 Gentamicin test system.
(a)
Identification. A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.(b)
Classification. Class II.