MULTIGENT GENTAMICIN

K060709 · Seradyn, Inc. · LCD · Jun 15, 2006 · Clinical Toxicology

Device Facts

• Record ID: K060709
• Device Name: MULTIGENT GENTAMICIN
• Applicant: Seradyn, Inc.
• Product Code: LCD · Clinical Toxicology
• Decision Date: Jun 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3450
• Device Class: Class 2

Intended Use

The Multigent Gentamicin assay is intended for the quantitative determination of Gentamicin in human serum or plasma on the Architect C8000 System. The results obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.

Device Story

Multigent Gentamicin assay is a homogeneous particle-enhanced turbidimetric immunoassay (particle agglutination) for use on the ARCHITECT c8000 System. Input: human serum or plasma samples. Principle: competitive binding; gentamicin in sample competes with gentamicin-coated microparticles for binding to anti-gentamicin monoclonal antibody. Output: absorbance inversely proportional to drug concentration. Used in clinical laboratory settings by trained personnel. Output provides quantitative drug levels to clinicians for monitoring therapeutic ranges and managing potential overdose, aiding in the prevention of renal and CNS toxicity.

Clinical Evidence

Bench testing only. Precision study (N=80 per control) showed total CVs of 2.15%–5.69%. Accuracy study (N=5 samples) demonstrated mean recovery of 100.31%. Linearity confirmed across range. Analytical sensitivity (LDD) is 0.09 µg/mL. Interference testing (bilirubin, hemoglobin, triglycerides, protein, HAMA, and common drugs) showed no significant impact. Method comparison against predicate (N=55) yielded R=0.996, slope=1.165, y-intercept=-0.719, demonstrating excellent correlation.

Technological Characteristics

Homogeneous particle-enhanced turbidimetric immunoassay. Two-reagent system (R1: anti-gentamicin monoclonal antibody; R2: gentamicin-coated microparticles). Uses Architect C8000 analyzer. Calibration via six-level calibrator set. Stabilizers include sodium azide. No specific ASTM material standards cited.

Indications for Use

Indicated for quantitative determination of gentamicin in human serum or plasma for monitoring therapy and diagnosing overdose.

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®/TDxFLx® Gentamicin (K904226)

Submission Summary (Full Text)

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# 510K SUMMARY

# This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is;

**COMPANY/CONTACT PERSON**

Seradyn. Inc 7998 Georgetown Road, Suite 1000 Indianapolis, IN 46268

JUN 15 2006

Establishment registration No: 1836010

Earl E. Knight III, MPA Regulatory Affairs Associate Telephone: [phone] Fax: [phone]

#### DATE PREPARED

March 14, 2006

#### DEVICE NAME

Trade Name:

Multigent® Gentamicin

Common Name: Enzyme Immunoassay, Gentamicin

Device Classification:

21 CFR 862.3450; Gentamicin Test System; ●■■■■

# INTENDED USE

The Multigent" Gentamicin assay is intended for the quantitative determination of Gentamicin in human serum or plasma on the Architect C8000 System.

# LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCY IS CLAIMED

Abbott TDx®/TDxFLx® Gentamicin (K904226)

# DESCRIPTION OF DEVICE

The Multigente Gentamicin assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle. The assay consists of reagents R1: anti-gentamicin monoclonal antibody and R2: gentamicin-coated microparticles. A six-level set of Multigent" Gentamicin Calibrators (A through F) is used to calibrate the assay.

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| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | | |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Device<br>Multigent® Gentamicin | Predicate<br>Abbott TDx®/TDxFLx® Gentamicin |
| Intended Use | The Multigent® Gentamicin assay is<br>intended for the quantitative<br>determination of Gentamicin in human<br>serum or plasma on the Architect<br>C8000 System. | The TDx®/TDxFLx® Gentamicin assay is<br>a reagent system for the quantitative<br>measurement of Gentamicin, an<br>antibiotic drug in human serum or<br>plasma. |
| Indications<br>for Use | The results obtained are used in the<br>diagnosis and treatment of<br>Gentamicin overdose and in<br>monitoring levels of Gentamicin to<br>ensure appropriate therapy. | The measurements obtained are used<br>in the diagnosis and treatment of<br>Gentamicin overdose to ensure<br>appropriate therapy. |
| Methodology | Homogeneous particle-enhanced<br>turbidimetric immunoassay (particle<br>agglutination) | Fluorescence Polarization<br>Immunoassay (FPIA) technology. |
| Reagent<br>Components | Two (2) reagent system:<br>Anti-Gentamicin Antibody Reagent<br>(R1) in buffers containing<br>stabilizers with sodium azide Gentamicin-coated Microparticle<br>Reagent (R2) in buffer containing<br>stabilizers with sodium azide | Three (3) reagent system:<br>Pretreatment Solution (P) Surfactant<br>in buffer containing protein stabilizer<br>and sodium azide. S Gentamicin Antiserum (Sheep) in<br>buffer with protein stabilizer and<br>Sodium azide. T Gentamicin Fluorescein Tracer in<br>buffer with protein stabilizer,<br>surfactant and Sodium azide |
| Calibration | Multigent® Gentamicin<br>Calibrators - six levels | Gentamicin Calibrators - six levels |

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

# SUMMARY OF CLINICAL TESTING

#### Precision

A precision study was performed using the Clinical and Laboratory Standards Institute (CLSI) Guideline NCCLS EP5: Evaluation of Precision Performance of Clinical Chery Canadial Include

.

| | N | Mean<br>µg/mL | Within Run | | Between Day | | Between Run | | Total | |
|--------------|----|---------------|------------|--------|-------------|--------|-------------|--------|-------|--------|
| | | | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) |
| Low Control | 80 | 2.68 | 0.08 | 2.93 | 0.12 | 4.37 | 0.06 | 2.17 | 0.15 | 5.69 |
| Mid Control | 80 | 6.47 | 0.07 | 1.09 | 0.12 | 1.91 | 0.07 | 1.07 | 0.16 | 2.44 |
| High Control | 80 | 9.41 | 0.14 | 1.53 | 0.13 | 1.34 | 0.07 | 0.70 | 0.20 | 2.15 |

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#### Accuracy

Accuracy was determined using a procedure described in CLSI Guideline NCCLS EP6-A. The samples were Accuracy was dolomined abing a problement in assay. A mean of the replicates for each sample was determined and percent recovery calculated.

| | | | | | | | % Recovery |
|---------------------------------|-------|-------|-------|------|-------|------|----------------------------------------------------|
| THEORETICAL<br>CONC.<br>(µg/mL) | Rep 1 | Rep 2 | Rep 3 | Mean | SD | CV | Acceptance<br>Criteria:<br>100±10% or<br>0.1 µg/mL |
| 0.25 | 0.23 | 0.28 | 0.26 | 0.26 | 0.025 | 9.82 | 102.67% |
| 1.00 | 1.02 | 0.99 | 0.98 | 1.00 | 0.021 | 2.09 | 99.67% |
| 2.25 | 2.24 | 2.22 | 2.21 | 2.22 | 0.015 | 0.69 | 98.81% |
| 4.50 | 4.44 | 4.55 | 4.42 | 4.47 | 0.070 | 1.57 | 99.33% |
| 8.00 | 8.12 | 7.99 | 8.15 | 8.09 | 0.085 | 1.05 | 101.08% |
| Mean Percent Recovery | | | | | | | 100.31% |

Image /page/2/Figure/3 description: This image shows a graph titled "Accuracy". The x-axis is labeled "Theoretical Conc. ug/mL" and ranges from 0 to 8. The y-axis is labeled "Mean Recovered Conc. ug/mL" and ranges from 0 to 10. A line is plotted on the graph, and the equation for the line is y = 1.01x + 0.024, with an R-squared value of 0.9999.

#### Linearity

A Gentamicin linearity standard was serially diluted and run in triplicate using the Multigent® Gentamicin assay. A mean of the replicates for each sample was determined and percent recovery was calculated.

| THEORETICAL<br>CONC.<br>(MG/ML) | Rep 1 | Rep 2 | Rep 3 | Mean<br>Recovered<br>Conc. | SD | %CV | % Recovery<br>Acceptance<br>Criteria:<br>$100\pm10%$ |
|---------------------------------|-------|-------|-------|----------------------------|-------|------|------------------------------------------------------|
| 6.88 | 7.14 | 7.31 | 7.14 | 7.20 | 0.098 | 1.36 | 104.60 |
| 5.16 | 5.20 | 5.23 | 5.39 | 5.27 | 0.102 | 1.94 | 102.20 |
| 3.44 | 3.50 | 3.65 | 3.70 | 3.62 | 0.104 | 2.88 | 105.14 |
| 1.72 | 1.59 | 1.67 | 1.66 | 1.64 | 0.044 | 2.66 | 95.35 |
| Mean Percent Recovery | | | | | | | 101.82 |

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Image /page/3/Figure/0 description: The image shows a linearity graph with the title "Linearity". The graph plots "Recovered conc. µg/mL" on the y-axis against "Theoretical conc. µg/mL" on the x-axis. The plot includes data points for "Theoretical vs. Recovered" and a linear regression line for "Linear (Theoretical vs. Recovered)", with the equation y = 1.0657x - 0.15 and an R-squared value of 0.9989.

#### Sensitivity

The Analytical Sensitivity or Least Detectable Dose (LDD) of the assay is defined as the concentration at which the lowest concentration is distinguishable from zero with 95% confidence.

A calibration curve was run. Calibrator A (0 µg/mL.) was run for a total of 20 replicates. The LDD was calculated using the following formula:

$$\text{'LDD} \qquad = \frac{2 \times \text{(SD rate of Zero Cal)}}{\text{(rate of Zero Cal - rate of 4} \text{'' non-zero cal)}} \qquad \text{' } \qquad \text{'Cuce of 4} \text{'' non-zero cal)}$$

Where:

- . Zero Cal = Cal A (0 uq/mL)
- . SD Zero Cal = standard deviation of the multiple determinations
- 1st Non-Zero Cal = Cal B (0.5 µg/mL) .

The average LDD is 0.09 µg/mL, supporting a claim of 0.1µg/mL.

#### Specificity

The Multigent® Gentamicin assay utilizes a mouse derived (ascites) Gentamicin monoclonal antibody directed against Gentamicin. There are no metabolites of Gentamicin.

#### Interferences

Interference were assessed using the Dose Response Method.

#### A. Endogenous Substances

#### Bilirubin

A Bilirubin Stock was prepared by adding bilirubin to normal human serum at 400 mg/dL. Dilutions were then made to produce bilirubin levels of 20, 40, and 60mg/dL. An Analyte Stock was prepared by adding Gentamicin to 10 mL of normal human serum. A 1:100 dilution of the Analyte Stock was prepared using each level of bilirubin. The control was prepared by diluting the Analyte Stock 1:100 with normal hurnan serum. Each level was assayed. Only the 20 mg/dl. data is shown.

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# Hemoglobin

A Hemoglobin stock solution was prepared from a human blood hemolysate. The hemolysate was diled to nomal human serum at 1.0 and 2.0g/dL hemoglobin. The Analyte Stock from above was diluted 1:100 with each level of hemoglobin. A control was prepared using normal human senum. Each level was assayed. Only the 2g/dL data is shown.

# Triglyceride

A 1691 mg/dL patient pool was spiked with Gentamicin stock. The spiked sample was run in
tripliedto triplicate.

#### Total Protein

A 12 g/dL stock of Human Serum Albumin (HSA) in saline was prepared. The sample was spiked with Gentamicin stock. The spiked sample was run in triplicate.

#### Rheumatoid Factor

A 582 IU patient pool was spiked with Gentamicin stock and run in triplicate.

Results are shown in the table Below.

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# ENDOGENOUS INTERFERING SUBSTANCE

| Interfering<br>Substance | Interferent<br>Concentration | N | Target<br>(No Interferent)<br>ug/mL | Mean<br>Recovery<br>ug/mL | % Recovery<br>Acceptance<br>Criteria:<br>100±10% |
|--------------------------|------------------------------|----|-------------------------------------|---------------------------|--------------------------------------------------|
| Bilirubin | 20mg/dL | 3 | 3.44 | 3.42 | ರಿಗಿ ನಿರ್ವಿಸಿದ |
| Hemoglobin | 2g/dL | 2 | 3.44 | 3.38 | 98.26 |
| Triglyceride | 1691 mg/dL | ನ | 3.44 | 3.30 | 95.83 |
| Total Protein | 12 g/dL | ನ | 3.44 | 3.21 | 93.41 |
| Rheumatoid Factor | 582 IU | ತಿ | 2.46 | 3.26 | 132.34 |

## B. HAMA

As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (HAMA) in the sample, which could cause falsely elevated results.

For this study, HAMA Type-1 and Type-2 samples were spiked with Gentamicin. The Mean Recovery for each (Type-1 and Type-2) of the duplicate HAMA samples was compared to the Mean Recovery of each respective Control (normal human serum).

Results are shown in the table below.

#### HAMA

| | Rep 1<br>µg/mL | Rep 2<br>µg/mL | Mean<br>Recovery<br>µg/mL | SD | CV | % Recovery<br>Acceptance Criteria:<br>$100\pm10%$ |
|----------------|----------------|----------------|---------------------------|-------|------|---------------------------------------------------|
| HAMA<br>Type-1 | 3.31 | 3.29 | 3.30 | 0.014 | 0.43 | 99.10 |
| Control | 3.40 | 3.26 | 3.33 | 0.099 | 2.97 | 100.00 |
| HAMA<br>Type-2 | 3.08 | 3.07 | 3.08 | 0.007 | 0.23 | 93.34 |
| Control | 3.40 | 3.26 | 3.33 | 0.099 | 2.97 | 100.00 |

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# C. Common Co-Administered Drugs

Gentamicin was spiked into normal human serum. Co-Administered drug stock concentrates were prepared at 100X of the initial concentration tested. A test aliquot was then prepared for each cross-reactant by combining 99 (or 9) volumes of the Gentamicin-spiked whole serum with 1 volume of the first and of of the United on the Gentament-spited while series while in the many

A control aliquot was prepared for each solvent system by combining 99 (or 9) volumes of the stock analyte solution with 1 volume of only of online by combining as (of sy voluntes of the stocure of the corresponding solvent used for the cross-reactant concentrate (no cross-reactant).

The test samples and control samples were then assayed in duplicate. Percent cross- reactivity was calculated using the following formula:

Percent Cross-Reactivity = $((D_A - D_T) / C) X 100$

Where:

$D_T$ = average observed concentration of the control solution

$D_A$ = average of the observed concentration of the cross-reactant test solution

C = concentration at which the cross-reactant is tested

Tabulated data is shown in the table below.

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| Cross-reactant Drug | Conc. Tested<br>µg/mL | Percent Cross-<br>Reactivity |
|----------------------|-----------------------|------------------------------|
| 5-Fluorocytosine | 30 | 0.5333 |
| Acetaminophen | 200 | ND |
| Acetyl Cysteine | 1000 | ND |
| Acetylsalicylic Acid | 300 | ND |
| Amikacin | 300 | ND |
| Amphotericin B | 100 | ND |
| Ampicillin | 50 | ND |
| Ascorbic Acid | 30 | -0.2333 |
| Carbenicillin | 2500 | ND |
| Cefamandole Naftate | 250 | ND |
| Cefoxitin | 1000 | ND |
| Cephalexin | 320 | ND |
| Cephalosporin C | 1000 | ND |
| Cephalothin | 1000 | ND |
| Chloramphenicol | 250 | ND |
| Clindamycin | 2000 | ND |
| Cyclosporin | 6000 | ND |
| Erythromycin | 500 | ND |
| Ethacrynic Acid | 400 | ND |
| Furosemide | 100 | ND |
| Fusidic Acid | 1000 | ND |
| Ibuprofen | 7000 | ND |
| Kanamycin A | 400 | 0.1017 |
| Kanamycin B | 400 | ND |
| Levodopa | 1000 | ND |
| Lincomycin | 2000 | ND |
| Methicillin | 200 | ND |
| Methotrexate | 50 | ND |
| Methylprednisolone | 200 | ND |
| Metronidazole | 1000 | ND |
| Neomycin | 1000 | ND |
| Netilmicin | 125 | 0.2533 |
| Oxytetracycline | 2000 | ND |
| Penicillin V | 10 | ND |
| Phenylbutazone | 1000 | ND |
| Prednisolone | 12 | -0.2920 |
| Rifampin | 50 | ND |
| Sisomicin | 10 | 50.35 |
| Spectinomycin | 100 | ND |
| Streptomycin | 400 | ND |
| Sulfadiazine | 1000 | ND |
| Sulfamethoxazole | 400 | ND |
| Tetracycline | 2000 | ND |
| Theophylline | 200 | ND |
| Ticarcillin | 100 | -0.4400 |
| Tobramycin | 100 | 0.1633 |
| Trimethoprim | 20 | 0.3000 |
| Vancomycin | 400 | ND |

*ND = Not Detected

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#### D. Anticoagulants

Studies were conducted to determine the performance characteristics of the assay for both serum and plasma samples containing Gentamicin.

Blood was drawn from at least ten healthy donors (no Gentamicin therapy) for each tube type listed below:

- plastic K2 EDTA tube
- · giass K3 EDTA tube
- · glass Plasma separator lithium heparin tube
- glass sodium heparin tube
- · glass lithium heparin tube
- · glass serum separator tube
- plastic tube with clot activator
- · glass tube; no additive (served as the control)
- · plastic tube; no additive

All tubes were processed per the manufacturers instructions. The serum or plasma was removed from the collection tubes and aliquoted into new tubes for testing. Serum or plasma from the removed type was spiked with Gentamicin. The samples were analyzed on the Architect C8000 analyzer in duplicate. Baseline results were obtained on day zero for each type of tube.

The results indicate that there is no significant difference between the recovery of Gentamicin in serum or plasma. The collection tubes evaluated show no adverse effects on the recovery of Gentamicin, within the experimental error for the spiking study.

A claim for assay application to both serum and plasma samples is thus supported.

#### Method Comparison

A study was conducted according to CLSI Guideline NCCLS EP9-A2: Method Comparison and Bias Estimation Using Patient Samples to compare accuracy of Gentamicin in serum assayed by the Multigent® Gentamicin assay to the Abbott TDx® TDxFLx® Gentamicin assay.

Serum and plasma samples, ranging from 0.78 to 9.02µg/mL Gentamicin, were first tested using Abbott's TDx Gentamicin assay. The same samples were then tested by the Multigent Gentamicin assay on the Architect C8000 analyzer.

Mean values for the Abbott TDx TDxFLx® Gentamicin assay reference method were plotted against those for the Multigent Gentamicin assay on the Architect C8000 (Figure 3). The results, using Passing – Bablok parameters, are:

> $N$ = 55 Slope = 1.165 y-intercept = -0.719 $R$ = 0.996 $R^2$ = 0.992

Results show excellent correlation between the two assays.

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# On-Board Stability

# 1) Calibration Curve stability

Calibration curve stability of a period of 28 days is supported by the data.

# 2) Reagent On-Board Stability

A 40 day on-board reagent stability claim is supported by the data.

# CONCLUSION

The Multigent" Gentamicin assay has been shown to be substantially equivalent to the Abbot
TDxYTDxFLx" Gentamicin assay. The performance testing verifies that the device func and that design specifications have been satisfied.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 15 2006

Earl E. Knight III, MPA Regulatory Affairs Associate Seradyn, Inc. 7998 Georgetown Road Suite 1000 Indianapolis, IN 46268-5260

k060709 Re:

> Trade/Device Name: Multigent® Gentamicin Regulation Number: 21 CFR§862.3450 Regulation Name: Gentamicin test system Regulatory Class: Class II Product Code: LCD Dated: May 23, 2006 Received: May 24, 2006

Dear Mr. Knight:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug and Cosmetic Act (Act) that do not require approval of a premarket approval application(PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registred - not liising (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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# Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll free no [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Alberto Guti

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Multigent® Gentamicin Device Name:

k060709 Indications for Use:

The Multigent Gentamicin assay is intended for the quantitative determination of · Gentamicin in human serum or plasma on the Architect C8000 System.

The results obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |
|-------------------------------------------------|---|--------|------------------------------------------------|
|-------------------------------------------------|---|--------|------------------------------------------------|

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Office of In Vitro Diagnostic Device

K060709

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