(78 days)
Not Found
No
The description details a homogeneous immunoassay based on measuring changes in scattered light or absorbance, a standard chemical analysis technique. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is an in vitro diagnostic (IVD) assay designed to quantify amikacin levels in human serum or plasma for therapeutic drug monitoring, not to directly treat or prevent a disease or condition.
Yes
The device determines the quantitative levels of amikacin in human serum or plasma. This information is clearly used for patient monitoring and care, specifically to achieve optimum therapeutic efficacy and minimize toxicity, which directly aids in medical decision-making related to drug dosage. Therefore, it is a diagnostic device.
No
The device is described as an "assay" and a "reagent kit" which are physical components used in a laboratory setting on automated clinical chemistry analyzers. The description details a homogeneous immunoassay based on microparticles and measuring changes in scattered light or absorbance, indicating a chemical and physical process, not purely 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 is a test performed on biological samples (serum or plasma) taken from the human body.
- Device Description: The description details a "homogeneous immunoassay" that measures changes in scattered light or absorbance. This is a laboratory test method used to analyze components in biological fluids.
- Purpose: The purpose is to determine "serum or plasma drug levels" to "achieve optimum therapeutic efficacy and minimize toxicity". This is a diagnostic purpose, providing information about the patient's physiological state (drug concentration) to guide medical treatment.
- Setting: The assay is used on "automated clinical chemistry analyzers", which are standard equipment in clinical laboratories.
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 a congenital abnormality or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The ONLINE TDM Amikacin assay is for the quantitative determination of amikacin in human serum or plasma on automated clinical chemistry analyzers.
Product codes
KLP
Device Description
The ONLINE TDM Amikacin assay is for the quantitative determination of amikacin in human serum or plasma on automated clinical chemistry analyzers. Determination of serum or plasma drug levels is required to achieve optimum therapeutic efficacy and minimize toxicity. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Amikacin reagent kits. The ONLINE TDM Amikacin assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with amikacin and rapidly aggregate in the presence of an amikacin antibody solution. When a sample containing amikacin is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formation is Thus, a classic inhibition curve with respect to amikacin inhibited. concentration is obtained, with the maximum rate of aggregation at the lowest amikacin concentration. By monitoring the change in scattered light or absorbance, a concentration-dependent curve is obtained.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Roche ONLINE TDM Amikacin 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. A summary of the evaluation studies is provided in Section IV of this submission. These experiments provide evidence that the Roche ONLINE TDM Amikacin assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Amikacin assay. The following table summarizes the precision and method comparison results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
NCCLS Precision, Within run:
Control 1: Mean (µg/ml) 5.43, SD (µg/ml) 0.10, CV% 1.7
Control 2: Mean (µg/ml) 16.88, SD (µg/ml) 0.23, CV% 1.4
Control 3: Mean (µg/ml) 33.27, SD (µg/ml) 0.47, CV% 1.4
NCCLS Precision, Total:
Control 1: Mean (µg/ml) 5.43, SD (µg/ml) 0.15, CV% 2.8
Control 2: Mean (µg/ml) 16.88, SD (µg/ml) 0.37, CV% 2.2
Control 3: Mean (µg/ml) 33.27, SD (µg/ml) 0.68, CV% 2.0
Method Comparison:
Linear Regression: ONLINE TDM Amikacin Vs. COBAS INTEGRA Amikacin (FPIA) method.
N=89, Range = 0.4 - 39.9 µg/ml
y=0.869x + 0.159
r=0.976
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
§ 862.3035 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
| OCT 1 0 | 2003 |
|---|---|
| --------- | ------ |
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) 521-7637 | |
| Contact Person: Kerwin Kaufman | |
| Date Prepared: July 23, 2003 | |
| 2) Device name | Proprietary name: ONLINE TDM Amikacin |
| Common name: Amikacin test system | |
| Classification name: Amikacin serum assay | |
| 3) Predicate device | We claim substantial equivalence to the currently marketed COBAS INTEGRA Amikacin (K991597). |
:
Continued on next page
1
510(k) Summary, Continued -
The ONLINE TDM Amikacin assay is for the quantitative determination of 4) Device Description amikacin in human serum or plasma on automated clinical chemistry analyzers. Determination of serum or plasma drug levels is required to achieve optimum therapeutic efficacy and minimize toxicity. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Amikacin reagent kits.
The ONLINE TDM Amikacin assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with amikacin and rapidly aggregate in the presence of an amikacin antibody solution. When a sample containing amikacin is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formation is Thus, a classic inhibition curve with respect to amikacin inhibited. concentration is obtained, with the maximum rate of aggregation at the lowest amikacin concentration. By monitoring the change in scattered light or absorbance, a concentration-dependent curve is obtained.
5.) Intended Use
The ONLINE TDM Amikacin assay is for the quantitative determination of amikacin in human serum or plasma on automated clinical chemistry analyzers.
Continued on next page
2
510(k) Summary, Continued
The Roche ONLINE TDM Amikacin 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 Amikacin assay (K991597).
The Roche ONLINE TDM Amikacin 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. A summary of the evaluation studies is provided in Section IV of this submission. These experiments provide evidence that the Roche ONLINE TDM Amikacin assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Amikacin assay. The following table summarizes the precision and method comparison results.
| | Roche ONLINE TDM Amikacin | | | Roche COBAS INTEGRA Amikacin
(Predicate) | | |
|--------------------------------|----------------------------------------------------------------------------------------|-----------|-----------|--------------------------------------------------------------------------------|-----------|-----------|
| NCCLS Precision,
Within run | Control 1 | Control 2 | Control 3 | Control 1 | Control 2 | Control 3 |
| Mean (µg/ml) | 5.43 | 16.88 | 33.27 | 5.3 | 14.3 | 27.3 |
| SD (µg/ml) | 0.10 | 0.23 | 0.47 | 0.29 | 0.25 | 0.58 |
| CV% | 1.7 | 1.4 | 1.4 | 5.4 | 1.8 | 2.1 |
| NCCLS Precision,
Total | Control 1 | Control 2 | Control 3 | Control 1 | Control 2 | Control 3 |
| Mean (µg/ml) | 5.43 | 16.88 | 33.27 | 5.3 | 14.3 | 27.3 |
| SD (µg/ml) | 0.15 | 0.37 | 0.68 | 0.37 | 0.36 | 0.78 |
| CV% | 2.8 | 2.2 | 2.0 | 7.0 | 2.5 | 2.9 |
| Method
Comparison | Linear Regression: ONLINE TDM
Amikacin Vs. COBAS INTEGRA
Amikacin (FPIA) method. | | | Linear Regression: COBAS INTEGRA 700
Amikacin Vs. Abbott TDx (FPIA) method. | | |
| | N=89, Range = 0.4 - 39.9 µg/ml
$y=0.869x + 0.159$
$r=0.976$ | | | N=120, Range = 0.30 - 41.8 µg/ml
$y=0.914x + 0.511$
$r=0.987$ | | |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles merging into one. The profiles are depicted in a flowing, abstract manner.
OCT 1 0 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Kerwin Kaufman Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K032279
Trade/Device Name: Roche Diagnostics ONLINE TDM Amikacin Regulation Number: 21 CFR 862.3035 Regulation Name: Amikacin test system Regulatory Class: Class II Product Code: KLP Dated: July 23, 2003 Received: July 24, 2003
Dear Mr. Kaufman:
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. Iisting 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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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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
| 510(k) Number (if known): | K032279 |
|---|---|
| Device Name: | Roche Diagnostics ONLINE TDM Amikacin |
| Indications for Use: | The ONLINE TDM Amikacin assay is for the quantitative determination of amikacin in human serum or plasma on automated clinical chemistry analyzers. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | ☑ OR Over-the-Counter Use ______ |
|---|---|
| (Optional format 1-2-96) |
Alberto
Division Sign-Off for Jean Cooper
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032279
.