(72 days)
Not Found
No
The summary describes a standard in vitro diagnostic assay for measuring drug levels and does not mention any AI or ML components.
No
The device measures drug levels to aid in diagnosis and treatment monitoring, but it does not directly administer therapy or physically interact with the patient for therapeutic purposes.
Yes
The device is described as being used "in the diagnosis and treatment of tobramycin overdose," directly indicating a diagnostic purpose.
No
The device description explicitly states it is a reagent kit used on automated clinical chemistry analyzers, indicating it is a chemical assay and not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended to measure tobramycin... in human plasma and serum." It also mentions that the measurements are "used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy." This clearly indicates that the device is used to examine specimens derived from the human body for the purpose of providing information for diagnosis, treatment, or monitoring.
- Device Description: The "Device Description" further clarifies that it is for the "quantitative determination of tobramycin in human serum or plasma."
- Performance Studies: The "Summary of Performance Studies" describes evaluations performed on the device using human samples (plasma and serum) to assess its performance characteristics relevant to clinical use.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ONLINE TDM Tobramycin assay is for the quantitative determination of tobramycin in human serum or plasma on Roche automated clinical chemistry analyzers.
The ONLINE TDM Tobramycin assay is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in human 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.
Product codes (comma separated list FDA assigned to the subject device)
KLB
Device Description
The ONLINE TDM Tobramycin assay is for the quantitative determination of tobramycin in human serum or plasma on Roche automated clinical chemistry analyzers. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Tobramycin reagent kits.
Tobramycin is an aminoglycoside antibiotic used in the treatment of infections caused by Pseudomonas aeruginosa, Proteus species, E. coli, Klebsiella, Serratia, Citrobacter, Staphylococcus aureus, Enterobacter and other microorganisms. Tobramycin's toxic effect is produced by interfering with ribosomal protein synthesis. Tobramycin undergoes very little, if any, metabolization and is, therefore, eliminated as the parent drug by glomerular filtration. The half-life of tobramycin in serum or plasma correlates closely with renal function and thus is quite variable between individuals and within one individual over time.2,3 Serum or plasma tobramycin concentration is also impacted by mode of administration, the volume of extracellular fluid, the duration of the treatment and physiological changes during the illness and therapy. The therapeutic range of tobramycin should be measured at peak as well as trough concentrations. In patients with pre-existing renal damage or those to whom tobramycin has been administered for prolonged periods or in doses above the therapeutic range, hearing impairment and/or nephrotoxicity may develop. Therefore, monitoring of peak and trough tobramycin serum or plasma levels is critical in the prevention of these serious complications with the adjustment of dosage administration as indicated.
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
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)
The Roche ONLINE TDM Tobramycin assay was evaluated for several performance characteristics including precision, lower detection limit, method comparison, specificity, and interfering substances. All of the evaluation studies gave acceptable results compared to the predicate device. These experiments provide evidence that the Roche ONLINE TDM Tobramycin assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Tobramycin assay.
Precision (NCCLS):
Within run: Control 1 Mean = 1.3 µg/ml, SD = 0.05 µg/ml, CV% = 3.9; Control 2 Mean = 4.2 µg/ml, SD = 0.04 µg/ml, CV% = 0.9; Control 3 Mean = 7.1 µg/ml, SD = 0.04 µg/ml, CV% = 0.6.
Total: Control 1 Mean = 1.3 µg/ml, SD = 0.07 µg/ml, CV% = 5.2; Control 2 Mean = 4.2 µg/ml, SD = 0.07 µg/ml, CV% = 1.7; Control 3 Mean = 7.1 µg/ml, SD = 0.09 µg/ml, CV% = 1.3.
Method Comparison:
Linear Regression: ONLINE TDM Tobramycin Vs. COBAS FP Tobramycin: N=55, Range = 0.2 - 9 µg/ml, y = 1.04x + 0.20, r = 0.996, SD (md 95) = 0.393.
Linear Regression: COBAS FP Tobramycin Vs. COBAS FARA II: N=196, Range = 0.23 - 10 ug/ml, y=0.930x - 0.090, r=0.995.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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JUN - 9 2006
Image /page/0/Picture/1 description: The image shows a handwritten alphanumeric string. The string appears to be "K060853". The characters are written in a cursive style with thick, dark strokes, suggesting the use of a marker or pen. The string is horizontally oriented and centered in the image.
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| 1) Submitter name, address, contact | Roche Diagnostics Corporation 9115 Hague Rd. Indianapolis, IN 46250 (317) 521-7688 Contact Person: Dimitris Demirtzoglou |
| 2) Device name | Proprietary name: ONLINE TDM Tobramycin |
| Common name: RADIOIMMUNOASSAY, TOBRAMYCIN | |
| Classification name: RADIOIMMUNOASSAY, TOBRAMYCIN | |
| 3) Predicate device | We claim substantial equivalence to the currently marketed COBAS INTEGRA Tobramycin (K964457). |
Continued on next page
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:
i
1
510(k) Summary, Continued
4) Device Description
The ONLINE TDM Tobramycin assay is for the quantitative determination of tobramycin in human serum or plasma on Roche automated clinical chemistry analyzers. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Tobramycin reagent kits.
Tobramycin is an aminoglycoside antibiotic used in the treatment of infections caused by Pseudomonas aeruginosa, Proteus species, E. coli, Klebsiella, Serratia, Citrobacter, Staphylococcus aureus, Enterobacter and other microorganisms. Tobramycin's toxic effect is produced by interfering with ribosomal protein synthesis. Tobramycin undergoes very little, if any, metabolization and is, therefore, eliminated as the parent drug by glomerular filtration. The half-life of tobramycin in serum or plasma correlates closely with renal function and thus is quite variable between individuals and within one individual over time.2,3 Serum or plasma tobramycin concentration is also impacted by mode of administration, the volume of extracellular fluid, the duration of the treatment and physiological changes during the illness and therapy. The therapeutic range of tobramycin should be measured at peak as well as trough concentrations. In patients with pre-existing renal damage or those to whom tobramycin has been administered for prolonged periods or in doses above the therapeutic range, hearing impairment and/or nephrotoxicity may develop. Therefore, monitoring of peak and trough tobramycin serum or plasma levels is critical in the prevention of these serious complications with the adjustment of dosage administration as indicated.
5.) Intended Use
The ONLINE TDM Tobramycin assay is for the quantitative determination of tobramycin in human serum or plasma on Roche automated clinical chemistry analyzers.
Continued on next page
2
510(k) Summary, Continued
The Roche ONLINE TDM Tobramycin assay is substantially equivalent to 6.) Comparison to the Predicate other products in commercial distribution intended for similar use. Most Device notably, it is substantially equivalent to the currently marketed Roche COBAS INTEGRA Tobramycin (K964457).
The Roche ONLINE TDM Tobramycin assay was evaluated for several performance characteristics including precision, lower detection limit, method comparison, specificity, and interfering substances. All of the evaluation studies gave acceptableresults compared to the predicate device. These experiments provide evidence that the Roche ONLINE TDM Tobramycin assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Tobramycinassay. The following table summarizes the precision and method comparison results.
| Roche ONLINE TDM N- | Roche COBAS FP | |||||
|---|---|---|---|---|---|---|
| acetylTobramycin | Tobramycin(Predicate) | |||||
| NCCLS Precision, | Control 1 | Control 2 | Control 3 | Control 1 | Control 2 | Control 3 |
| Within run | ||||||
| Mean (µg/ml) | 1.3 | 4.2 | 7.1 | 1.4 | 3.5 | 7.5 |
| SD (µg/ml) | 0.05 | 0.04 | 0.04 | 0.04 | 0.07 | 0.14 |
| CV% | 3.9 | 0.9 | 0.6 | 2.6 | 2.1 | 1.9 |
| NCCLS Precision, | Control 1 | Control 2 | Control 3 | Control 1 | Control 2 | Control 3 |
| Total | ||||||
| Mean (µg/ml) | 1.3 | 4.2 | 7.1 | 1.4 | 3.5 | 7.5 |
| SD (µg/ml) | 0.07 | 0.07 | 0.09 | 0.09 | 0.16 | 0.30 |
| CV% | 5.2 | 1.7 | 1.3 | 6.0 | 4.5 | 4.0 |
| Method | Linear Regression: ONLINE TDM | Linear Regression: COBAS FP Tobramycin | ||||
| Comparison | Tobramycin Vs. COBAS FP Tobramycin | Vs. COBAS FARA II | ||||
| N=55, Range = 0.2 - 9 µg/ml | ||||||
| y = 1.04x + 0.20 | N=196, Range = 0.23 - 10 ug/ml | |||||
| r = 0.996 | y=0.930x - 0.090 | |||||
| SD (md 95) = 0.393 | r=0.995 |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the logo.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 9 2006
Mr. Dimitris Demirtzoglou Regulatory Affairs Consultant Roche Diagnostics Corp. 9115 Hague Road Indianapolis, IN 46250-0457
Re: K060853
Trade/Device Name: ONLINE TDM Tobramycin Regulation Number: 21 CFR §862.3900 Regulation Name: Tobramycin test system Regulatory Class: Class II Product Code: KLB Dated: March 28, 2006 Received: March 29, 2006
Dear Mr. Demirtzoglou:
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: 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).
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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 vours.
Alberto Gutierrez, Ph.D.
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
5
Indications for Use
510(k) Number (if known): K O60 & S
Device Name: ONLINE TDM Tobramycin
Indications For Use:
The ONLINE TDM Tobramycin assay is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in human 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.
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 of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
CLC
Office
Device
Diagnostic
and Safety
00000 Kolo0853
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