(28 days)
Abbott TDx/TDxFLx Amikacin (K802669)
No
The device description details a standard homogeneous immunoassay based on particle agglutination and competitive binding, which are established biochemical principles, not AI/ML. The analysis relies on measuring absorbance and interpolating from a calibration curve, a traditional analytical method. There is no mention of AI, ML, or related concepts in the summary.
No.
The device is an in vitro diagnostic test for measuring amikacin levels, which is used for monitoring and diagnosis, not for providing therapy.
Yes
The device is described as "intended for the quantitative determination of amikacin in human serum or plasma" and "The results obtained are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy," which directly indicates its use in diagnosis.
No
The device description clearly states it is a "homogeneous assay utilizing particle agglutination technology" and consists of "reagents R1: anti-amikacin monoclonal antibody and R2: amikacin-coated microparticles." These are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative determination of amikacin in human serum or plasma". This indicates that the device is used to test samples taken from the human body (in vitro) to provide information about a person's health status (diagnostic).
- Purpose of Results: The results are used "in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy." This directly relates to providing diagnostic information and guiding medical treatment.
- Device Description: The description details a laboratory assay system that analyzes biological samples (serum or plasma) using chemical reactions (particle agglutination, competitive binding) to measure a substance (amikacin). This is characteristic of an in vitro diagnostic device.
- Performance Studies: The performance studies describe analytical validation performed on the assay using biological samples or simulated biological samples (spiked serum). This is standard practice for IVD devices.
- Predicate Device: The mention of a predicate device (Abbott TDx/TDxFLx Amikacin) which is also an IVD, further supports that this device falls into the same category.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QMS® Amikacin assay is intended for the quantitative determination of amikacin in human serum or plasma on automated clinical chemistry analyzers.
The results obtained are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.
Product codes
KLO
Device Description
The QMS® Amikacin assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle.
In particle agglutination assays, the degree of agglutination is inversely proportional to the quantity of free drug in the reaction well. Hence, if no drug is present in the sample, the antibodies in the QMS Amikacin Antibody Reagent (R1) will bind only to the bound drug on the particle which will cause it to agglutinate and will result in higher absorbance. If increased amount of competing drug is present in the sample, this will result in decreased binding of bound drug by the antibody, resulting in a relative decrease in particle agglutination. This in turn results in lower absorbance.
The precise relationship between particle agglutination of the unlabeled drug in the sample is established by measuring the absorbance values of calibrators with known concentration of the drug. The absorbance of unknown samples can be interpolated from the absorbance values of the calibration curve and the concentration of the drug present in the sample can be calculated.
The assay consists of reagents R1: anti-amikacin monoclonal antibody and R2: amikacin-coated microparticles. A six-level set of QMS® Amikacin Calibrators (A through F) is used to calibroothe assay.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
Accuracy: Accuracy by Recovery was determined by spiking USP traceable amikacin into human serum negative for the drug to achieve concentrations of 18.4 and 9.2ug/mL. The samples were analyzed in duglicate with the QMS Amikacin assay. Mean Percent Recovery: 94.02.
Linearity: Linearity by Dilution was determined by a study based on the NCCLS guideline EP6: Evaluation of the Linearity of Quantitative Measurement. A linear regression analysis plot of USP Amikacin against resulted in a line with a correlation coefficient (R2) of 0.9998, demonstrating that the assay is linear. Mean Percent Recovery: 100.41%.
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. The average LDD is 0.54 ug/mL, supporting a claim of 0.8 ug/mL.
Assay Range: Based on the Accuracy, Linearity, and Sensitivity (LDD) data, the package insert claim for the reportable range for the assay will be 1.5 to 50 µg/mL.
Method Comparison: A study was conducted according to NCCLS Guideline EP9: Method Comparison and Bias Estimation Using Patient Samples to compare accuracy of recovery of amikacin in serum assayed by the QMS® Amikacin assay to the Abbott TDx/TDxFLx® Amikacin assay. Mean values for the TDx reference method were plotted against those for the QMS on Hitachi 717. The results, using Passing - Bablok parameters, are: N = 56 Slope = 1.00 y-intercept = 0.25 R = 0.996 R2 = 0.992. Results show excellent correlation between the two assays.
Precision: A precision study was performed using the National Committee for Clinical Laboratory Standards (NCCLS) guideline EP5: Evaluation of Precision Performance of Clinical Chemistry Devices.
Sample size: 80 for Low, Mid, and High control.
Results: Low Control Mean 4.09 µg/mL, Total SD 0.41, Total CV (%) 9.94. Mid Control Mean 12.00 µg/mL, Total SD 0.74, Total CV (%) 6.22. High Control Mean 24.37 µg/mL, Total SD 1.54, Total CV (%) 6.32. Acceptance Criteria:
§ 862.3035 Amikacin test system.
(a)
Identification. An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.(b)
Classification. Class II.
0
NOV - 1 2005
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
Establishment registration No: 1836010
Jack Rogers Manager of Regulatory Affairs Telephone: (317) 610-3823 Fax: (317) 610-0018
DATE PREPARED
October 25, 2005
DEVICE NAME
| Trade Name: | QMS® Amikacin |
|---|---|
| Common Name: | Homogeneous Particle-Enhanced Turbidimetric Immunoassay |
| Device Classification: | 21 CFR 862.3035; Amikacin Test System; Class II |
INTENDED USE
The QMS® Amikacin assay is intended for the quantitative determination of amikacin in human serum or plasma on automated clinical chemistry analyzers.
The results obtained are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.
LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCY IS CLAIMED
Abbott TDx/TDxFLx Amikacin (K802669)
DESCRIPTION OF DEVICE
The QMS® Amikacin assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle.
In particle agglutination assays, the degree of agglutination is inversely proportional to the quantity of free drug in the reaction well. Hence, if no drug is present in the sample, the antibodies in the QMS Amikacin Antibody Reagent (R1) will bind only to the bound drug on the particle which will cause it to agglutinate and will result in higher absorbance. If increased amount of competing drug is present in the sample, this will result in decreased binding of bound drug by the antibody, resulting in a relative decrease in particle agglutination. This in turn results in lower absorbance.
The precise relationship between particle agglutination of the unlabeled drug in the sample is established by measuring the absorbance values of calibrators with known concentration of the drug. The absorbance of unknown samples can be interpolated from the absorbance values of the calibration curve and the concentration of the drug present in the sample can be calculated.
The assay consists of reagents R1: anti-amikacin monoclonal antibody and R2: amikacin-coated microparticles. A six-level set of QMS® Amikacin Calibrators (A through F) is used to calibroothe assay.
1
| | Device
Seradyn QMS® Amikacin | Predicate
Abbott TDx/TDxFLx Amikacin |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The QMS Amikacin assay is for the
quantitative determination of amikacin
in human serum or plasma on
automated clinical chemistry
analyzers | The TDx/TDxFLx Amikacin assay is
a reagent system for the
quantitative measurement of
amikacin, an aminoglycoside
antibiotic drug, in serum or plasma. |
| Indications
for Use | The results obtained are used in the
diagnosis and treatment of amikacin
overdose and in monitoring levels of
amikacin to ensure appropriate
therapy. | The measurements obtained are
used in the diagnosis and treatment
of amikacin overdose and in
monitoring levels of amikacin to
ensure appropriate therapy. |
| Methodology | Homogeneous particle-enhanced
turbidimetric immunoassay (particle
agglutination) | Fluorescence Polarization
Immunoassay (FPIA) technology. |
| Reagent
Components | Two (2) reagent system:
• Anti-amikacin Antibody Reagent
(R1) in buffers containing
stabilizers with sodium azide
• Amikacin-coated Microparticle
Reagent (R2) in buffer containing
stabilizers with sodium azide | Three (3) reagent system:
• Pretreatment Solution (P)
Surfactant in buffer containing
protein stabilizer and sodium
azide.
• S Amikacin Antiserum (Sheep) in
buffer with protein stabilizer and
Sodium azide.
• T Amikacin Fluorescein Tracer in
buffer with protein stabilizer,
surfactant and Sodium azide |
| Calibration | QMS Amikacin
Calibrators - six levels | Amikacin Calibrators - six levels |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
SUMMARY OF CLINICAL TESTING
Accuracy
Accuracy by Recovery was determined by spiking USP traceable amikacin into human serum negative for the drug to achieve concentrations of 18.4 and 9.2ug/mL. The samples were analyzed in duglicate with the QMS Amikacin assay.
| THEORETICAL
CONC.
(µG/ML) | Rep 1 | Rep 2 | Mean
Recovered
Conc. | SD | CV | % Recovery
Acceptance
Criteria:
$100±10%$ |
|---------------------------------|-------|-------|----------------------------|------|-------|----------------------------------------------------|
| 9.2 | 8.92 | 8.72 | 8.82 | 0.14 | 1.59% | 95.87 |
| 18.4 | 16.79 | 17.13 | 16.96 | 0.17 | 1.00% | 92.17 |
| Mean Percent Recovery | | | | | | 94.02 |
2
Linearity
Linearity by Dilution was determined by a study based on the NCCLS guideline EP6: Evaluation of the Linearity of Quantitative Measurement.
A linear regression analysis plot of USP Amikacin against resulted in a line with a correlation coefficient (R2) of 0.9998, demonstrating that the assay is linear.
| THEORETICAL
CONC.
(µg/mL) | Rep 1 | Rep 2 | Mean
Recovered
Conc. | SD | CV | % Recovery |
|---------------------------------|-------|-------|----------------------------|------|------|------------|
| 1.5 | 1.77 | 1.57 | 1.67 | 0.10 | 5.99 | 111. 33% |
| 6.5 | 6.44 | 6.51 | 6.48 | 0.04 | 0.54 | 99.69% |
| 15.0 | 14.84 | 14.49 | 14.67 | 0.18 | 1.19 | 97.80% |
| 27.5 | 26.69 | 25.95 | 26.32 | 0.37 | 1.41 | 95.71% |
| 42.5 | 41.24 | 41.63 | 41.44 | 0.20 | 0.47 | 97.51% |
| Mean Percent Recovery | | | | | | 100.41% |
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.
The average LDD is 0.54 ug/mL, supporting a claim of 0.8 ug/mL.
Assay Range
Based on the Accuracy, Linearity, and Sensitivity (LDD) data, the package insert claim for the reportable range for the assay will be 1.5 to 50 µg/mL.
Method Comparison
A study was conducted according to NCCLS Guideline EP9: Method Comparison and Bias Estimation Using Patient Samples to compare accuracy of recovery of amikacin in serum assayed by the QMS® Amikacin assay to the Abbott TDx/TDxFLx® Amikacin assay.
Mean values for the TDx reference method were plotted against those for the QMS on Hitachi 717. The results, using Passing - Bablok parameters, are:
N = 56 Slope = 1.00 y-intercept = 0.25 R = 0.996 R2 = 0.992
Results show excellent correlation between the two assays.
3
Precision
A precision study was performed using the National Committee for Clinical Laboratory Standards (NCCLS) guideline EP5: Evaluation of Precision Performance of Clinical Chemistry Devices.
| Within Run | Between Day | Total | ||||||
|---|---|---|---|---|---|---|---|---|
| N | Mean | |||||||
| µg/mL | SD | CV (%) | SD | CV (%) | SD | CV (%) | ||
| Low Control | 80 | 4.09 | 0.22 | 5.37 | 0.19 | 4.77 | 0.41 | 9.94 |
| Mid Control | 80 | 12.00 | 0.21 | 1.79 | 0.08 | 0.70 | 0.74 | 6.22 |
| High Control | 80 | 24.37 | 0.47 | 1.93 | 0.40 | 1.65 | 1.54 | 6.32 |
Acceptance Criteria: