(69 days)
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No
The summary describes a standard in vitro diagnostic reagent test kit for quantitative analysis, with no mention of AI or ML technologies. The performance studies focus on traditional analytical metrics like precision and accuracy.
No.
This device is an in vitro diagnostic reagent test kit for quantitative analysis of a drug in human serum or plasma, which is for diagnostic purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" states that the device is "an in vitro diagnostic reagent test kit," and the "Device Description" also labels it as "an in vitro diagnostic reagent test kit."
No
The device is described as an "in vitro diagnostic reagent test kit," which inherently includes physical components (reagents) and is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" explicitly states: "an in vitro diagnostic reagent test kit for the quantitative analysis of gentamicin in human serum or plasma."
The "Device Description" also confirms this: "modified Emit® 2000 Gentamicin Assay, an in vitro diagnostic reagent test kit for the quantitative analysis of gentamicin in human serum or plasma."
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
an in vitro diagnostic reagent test kit for the quantitative analysis of gentamicin in human serum or plasma.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Study Type: Within-run and Total Precision
Sample Size: Not Found
Key Results: Within-run precision CVs: 1.6 to 5.6%. Total precision CVs: 2.7 to 6.7%.
Study Type: Accuracy
Sample Size: 104 patient samples
Key Results: Analysis demonstrate excellent correlation with the Abbott TDx Gentamicin Assay (FPIA). Slope: 0.94, Intercept (ng/mL): 0.10, Mean (ng/mL) Emit 2000 Assay: 2.706, Mean (ng/mL) FPIA Method: 2.544, Standard Error of the Estimate (ng/mL): 0.18, Correlation: 0.995.
Key Metrics
Within-run precision CVs: 1.6 to 5.6%. Total precision CVs: 2.7 to 6.7%.
Correlation: 0.995
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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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.