(101 days)
Not Found
No
The summary describes a standard homogeneous immunoassay based on particle agglutination and competitive binding. There is no mention of AI, ML, or any computational methods that would suggest their use in the device's operation or data analysis beyond standard statistical calculations for performance metrics.
No.
The device is an in vitro diagnostic (IVD) assay designed to measure tobramycin levels in human samples, which aids in diagnosis and monitoring, but it does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section states that "The results obtained are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to help ensure appropriate therapy." This clearly indicates its role in diagnosis.
No
The device description clearly states it is a homogeneous assay utilizing particle agglutination technology and consists of reagents (antibody and microparticles) and calibrators. 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 "quantitative determination of tobramycin in human serum or plasma". This involves testing biological samples (serum or plasma) outside of the body (in vitro).
- Purpose: The results are used "in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to help ensure appropriate therapy." This directly relates to providing information for medical diagnosis and treatment decisions.
- Device Description: The device is a "homogeneous assay utilizing particle agglutination technology" and consists of "reagents R1: anti- tobramycin monoclonal antibody and R2: tobramycin -coated microparticles." These are components designed to perform a test on a biological sample.
- Performance Studies: The performance studies describe testing the device's ability to accurately measure tobramycin in human serum, which is a key characteristic of an IVD.
- Predicate Device: The mention of a predicate device (Abbott TDx/TDxFLx Tobramycin assay) which is also an IVD, further supports the classification of this device as an IVD.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of any tissue or organ for potential transplantation, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The QMS® Tobramycin assay is intended for the quantitative determination of tobramycin in human serum or plasma on automated clinical chemistry analyzers.
The results obtained are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to help ensure appropriate therapy.
Product codes (comma separated list FDA assigned to the subject device)
LCR
Device Description
The QMS® Tobramycin 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- tobramycin monoclonal antibody and R2: tobramycin -coated microparticles. A six-level set of QMS® Tobramycin Calibrators (A through F) is used to calibrate the 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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy
Accuracy by Recovery was determined by spiking tobramycin into human serum negative for the drug to achieve concentrations across the range of the assay. The samples were analyzed in triplicate with the QMS Tobramycin assay.
Mean Percent Recovery: 94.14%
Linearity
A tobramycin in human serum pool was diluted with human serum negative for tobramycin to achieve concentrations across the range of the assay. The samples were analyzed in triplicate with the QMS Tobramycin assay.
A linear regression analysis plot of the data resulted in a line with a correlation coefficient (R') of 0.9996, demonstrating that the assay is linear.
Sensitivity
The Functional Sensitivity or Limit of Quantitation (LOQ) of the assay is defined as the lowest concentration of an analyte that can be reliably detected and at which the total error meets accuracy requirements. The LOQ was determined to be 0.4 µg/mL.
Assay Range
Based on the Accuracy, Linearity, and Sensitivity data, the package insert claim for the reportable range for the assay will be 0.4 to 10 ug/mL.
Method Comparison
A study was conducted according to NCCLS Guideline EP9-A2: Method Comparison and Bias Estimation Using Patient Samples to compare accuracy of recovery of tobramycin in serum assayed by the QMS® Tobramycin assay to the Abbott TDx/TDxFLx Tobramycin assay.
N = 67
Slope = 0.979
y-intercept = - 0.086
R = 0.992
R2 = 0.984
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-A2: Evaluation of Precision Performance of Clinical Chemistry Devices.
Acceptance Criteria:
§ 862.3900 Tobramycin test system.
(a)
Identification. A tobramycin test system is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.(b)
Classification. Class II.
0
Kolo098
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: K060998
COMPANY/CONTACT PERSON
Seradyn, Inc 7998 Georgetown Road, Suite 1000 Indianapolis, IN 46268
Establishment registration No: 1836010
Earl E. Knight III, MPA Regulatory Affairs Associate Telephone: (317) 544-0639 Fax: (317) 610-0018
DATE PREPARED
June 22, 2006
DEVICE NAME
| Trade Name: | QMS® Tobramycin |
|---|---|
| Common Name: | Homogeneous Particle Enhanced Turbidimetric Immunoassay |
| Device Classification: | 21 CFR 862.3900; Tobramycin Test System; Class II |
INTENDED USE
The QMS® Tobramycin assay is intended for the quantitative determination of tobramycin in human serum or plasma on automated clinical chemistry analyzers.
The results obtained are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to help ensure appropriate therapy.
LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCY IS CLAIMED
Abbott TDx/TDxFLx Tobramycin assay (K802668)
DESCRIPTION OF DEVICE
The QMS® Tobramycin 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- tobramycin monoclonal antibody and R2: tobramycin -coated microparticles. A six-level set of QMS® Tobramycin Calibrators (A through F) is used to calibrate the assay.
JUL 2 1 2006
1
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| | Device
Seradyn QMS® Tobramycin | Predicate
Abbott TDx/TDxFLx Tobramycin |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The QMS Tobramycin assay is intended
for the quantitative determination of
Tobramycin in human serum or plasma on
automated clinical chemistry analyzers | The TDx/TDxFLx Tobramycin assay is a
reagent system for the quantitative
measurement of tobramycin, an
aminoglycoside antibiotic drug, in serum or
plasma. |
| Indications
for Use | The results obtained are used in the
diagnosis and treatment of tobramycin
overdose and in monitoring levels of
tobramycin to help ensure appropriate
therapy. | The measurements obtained are used in the
diagnosis and treatment of tobramycin
overdose and in monitoring levels of
tobramycin to ensure appropriate therapy. |
| Methodology | Homogeneous particle-enhanced
turbidimetric immunoassay (particle
agglutination) | Fluorescence Polarization Immunoassay
(FPIA) technology. |
| Reagent
Components | Two (2) reagent system:
• Anti-tobramycin Antibody
Reagent (R1) in buffers
containing stabilizers with
sodium azide
• Tobramycin-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 Tobramycin Antiserum (Sheep)
in buffer with protein stabilizer and
Sodium azide.
• T Tobramycin Fluorescein Tracer in
buffer with protein stabilizer,
surfactant and Sodium azide |
| Calibration | QMS Tobramycin
Calibrators - six levels | Tobramycin Calibrators - six levels |
SUMMARY OF CLINICAL TESTING
Accuracy
Accuracy by Recovery was determined by spiking tobramycin into human serum negative for the drug to achieve concentrations across the range of the assay. The samples were analyzed in triplicate with the QMS Tobramycin assay.
| Theoretical
Conc.
(ug/mL) | Rep 1
(ug/mL | Rep 2
(ug/mL) | Rep 3
(ug/mL) | Mean
Recovered
Conc.
(ug/mL) | SD | CV(%) | % Recovery
Acceptance
Criteria:
100±10% |
|---------------------------------|-----------------|------------------|------------------|---------------------------------------|-------|-------|--------------------------------------------------|
| 1.5 | 1.39 | 1.32 | 1.37 | 1.36 | 0.036 | 2.65 | 90.67% |
| 3.0 | 2.82 | 2.82 | 2.71 | 2.78 | 0.064 | 2.30 | 92.67% |
| 4.5 | 4.24 | 4.39 | 4.26 | 4.30 | 0.081 | 1.88 | 95.56% |
| 6.0 | 5.77 | 5.87 | 5.95 | 5.86 | 0.090 | 1.54 | 97.67% |
| Mean Percent Recovery | | | | | | | 94.14% |
2
Linearity
A tobramycin in human serum pool was diluted with human serum negative for tobramycin to achieve concentrations across the range of the assay. The samples were analyzed in triplicate with the QMS Tobramycin assay.
A linear regression analysis plot of the data resulted in a line with a correlation coefficient (R') of 0.9996, demonstrating that the assay is linear.
| Theoretical
Conc.
(µg/mL) | Rep 1
(µg/mL) | Rep 2
(µg/mL) | Rep 3
(µg/mL) | Mean
Recovered
Conc.
(µg/mL) | SD | CV(%) | % Recovery
Acceptance
Criteria:
100±10% |
|---------------------------------|------------------|------------------|------------------|---------------------------------------|-------|--------|--------------------------------------------------|
| 0.465 | 0.42 | 0.51 | 0.52 | 0.48 | 0.055 | 11.395 | 104.05% |
| 0.929 | 0.94 | 0.95 | 0.83 | 0.91 | 0.067 | 7.3437 | 97.60% |
| 1.858 | 1.85 | 1.79 | 1.82 | 1.82 | 0.030 | 1.6484 | 97.95% |
| 3.716 | 3.54 | 3.51 | 3.55 | 3.53 | 0.021 | 0.5892 | 95.08% |
| 5.574 | 5.51 | 5.42 | 5.49 | 5.47 | 0.047 | 0.8634 | 98.19% |
| 7.432 | 7.39 | 7.36 | 7.24 | 7.33 | 0.079 | 1.0828 | 98.63% |
| 9.290 | 9.22 | 9.30 | 9.35 | 9.29 | 0.066 | 0.7059 | 100.00% |
| 11.148 | 10.96 | 11.05 | 11.10 | 11.04 | 0.071 | 0.6428 | 99.00% |
| 13.006 | 13.03 | 12.89 | 13.07 | 13.00 | 0.095 | 0.7272 | 99.93% |
| 14.864 | 15.11 | 14.55 | 14.96 | 14.87 | 0.290 | 1.949 | 100.06% |
| 16.722 | 15.30 | 16.81 | 16.65 | 16.25 | 0.829 | 5.1034 | 97.20% |
| 18.580 | 18.65 | 18.54 | 17.33 | 18.17 | 0.732 | 4.0302 | 97.81% |
Sensitivity
The Functional Sensitivity or Limit of Quantitation (LOQ) of the assay is defined as the lowest concentration of an analyte that can be reliably detected and at which the total error meets accuracy requirements. The LOQ was determined to be 0.4 µg/mL.
Assay Range
Based on the Accuracy, Linearity, and Sensitivity data, the package insert claim for the reportable range for the assay will be 0.4 to 10 ug/mL.
Method Comparison
A study was conducted according to NCCLS Guideline EP9-A2: Method Comparison and Bias Estimation Using Patient Samples to compare accuracy of recovery of tobramycin in serum assayed by the QMS® Tobramycin assay to the Abbott TDx/TDxFLx Tobramycin assay.
Mean values for the TDx reference method were plotted against those for the QMS on Hitachi 917 . The results, using Passing - Bablok parameters, are:
N = 67 Slope = 0.979 y-intercept = - 0.086 R = 0.992 R2 = 0.984
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-A2: Evaluation of Precision Performance of Clinical Chemistry Devices.
| | N | Mean
µg/mL | Within Run | | Between Day | | Total | |
|--------------|----|---------------|------------|--------|-------------|--------|-------|--------|
| | | | SD | CV (%) | SD | CV (%) | SD | CV (%) |
| Low Control | 80 | 1.11 | 0.022 | 1.98 | 0.054 | 4.86 | 0.084 | 7.57 |
| Mid Control | 80 | 3.83 | 0.050 | 1.31 | 0.120 | 3.13 | 0.162 | 4.23 |
| High Control | 80 | 8.06 | 0.131 | 1.63 | 0.057 | 0.71 | 0.343 | 4.26 |
Acceptance Criteria: Trade/Device Name: QMS® Tobramycin Regulation Number: 21 CFR& 862.3900 Regulation Name: Tobramycin test system Regulatory Class: Class II Product Code: LCR Dated: June 29, 2006 Received: June 30, 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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour 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: registration and listing (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).
7
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 (240) 276-0484. 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 number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
8
Indications for Use
1060998 510(k) Number (if known):
QMS® Tobramycin Device Name:
Indications for Use:
The QMS® Tobramycin assay is intended for the quantitative determination of tobramycin in human serum or plasma on automated clinical chemistry analyzers.
The results obtained are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to help ensure appropriate therapy.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE: BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence nce of of CDRH, coRH. (Office Cortice of of the In Vitro Vitro Diagr Diagnostic Devices (OIVD)
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Office of In Vitro Diagnostic Device
Evaluation and Safety