EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS

K962519 · Behring Diagnostics, Inc. · LCD · Sep 4, 1996 · Clinical Toxicology

Device Facts

• Record ID: K962519
• Device Name: EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS
• Applicant: Behring Diagnostics, Inc.
• Product Code: LCD · Clinical Toxicology
• Decision Date: Sep 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3450
• Device Class: Class 2

Intended Use

The Emit® 2000 Gentamicin Assay is an in vitro diagnostic reagent test kit for the quantitative analysis of gentamicin in human serum or plasma.

Device Story

Emit 2000 Gentamicin Assay; in vitro diagnostic reagent kit. Input: human serum or plasma samples. Principle: homogeneous enzyme immunoassay (Emit technology). Output: quantitative gentamicin concentration (ng/mL). Used in clinical laboratory settings; operated by laboratory technicians/pathologists. Results used by clinicians for therapeutic drug monitoring of gentamicin to optimize dosing and minimize toxicity. Benefits: rapid, accurate quantification of drug levels to guide patient treatment.

Clinical Evidence

Bench testing only. Precision evaluated using three control levels (subtherapeutic, therapeutic, upper therapeutic) per NCCLS EP5-T2; within-run CVs 1.6-5.6%, total CVs 2.7-6.7%. Accuracy assessed via 104 patient samples compared to Abbott TDx FPIA method; correlation coefficient 0.995, slope 0.94, intercept 0.10 ng/mL.

Technological Characteristics

Homogeneous enzyme immunoassay reagent kit. Quantitative analysis performed on automated clinical chemistry analyzers (e.g., Syva 30R).

Indications for Use

Indicated for the quantitative measurement of gentamicin levels in human serum or plasma to assist in therapeutic drug monitoring.

Regulatory Classification

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.

Predicate Devices

• Abbott TDx Gentamicin Assay (K904226)

Submission Summary (Full Text)

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K962519
SEP - 4 1996
BEHRING

# 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.

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