(78 days)
The ONLINE TDM Amikacin assay is for the quantitative determination of amikacin in human serum or plasma on automated clinical chemistry analyzers.
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 inhibited. Thus, a classic inhibition curve with respect to amikacin 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.
The provided document describes the Roche Diagnostics ONLINE TDM Amikacin assay, a device for the quantitative determination of amikacin in human serum or plasma. The primary study presented is a substantial equivalence comparison to a predicate device, the COBAS INTEGRA Amikacin assay (K991597).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical targets for each performance characteristic. Instead, it states that "All of the evaluation studies gave acceptable results compared to the predicate device." The performance reported is in comparison to the predicate device, implying that achieving comparable performance to the legally marketed predicate was the acceptance criterion.
| Performance Characteristic | Acceptance Criteria (Implied: Comparable to Predicate) | Reported Device Performance (ONLINE TDM Amikacin) | Predicate Device Performance (COBAS INTEGRA Amikacin) |
|---|---|---|---|
| NCCLS Precision, Within run | |||
| Control 1 Mean (µg/ml) | Comparable to 5.3 µg/ml | 5.43 µg/ml | 5.3 µg/ml |
| Control 1 SD (µg/ml) | Comparable to 0.29 µg/ml | 0.10 µg/ml | 0.29 µg/ml |
| Control 1 CV% | Comparable to 5.4% | 1.7% | 5.4% |
| Control 2 Mean (µg/ml) | Comparable to 14.3 µg/ml | 16.88 µg/ml | 14.3 µg/ml |
| Control 2 SD (µg/ml) | Comparable to 0.25 µg/ml | 0.23 µg/ml | 0.25 µg/ml |
| Control 2 CV% | Comparable to 1.8% | 1.4% | 1.8% |
| Control 3 Mean (µg/ml) | Comparable to 27.3 µg/ml | 33.27 µg/ml | 27.3 µg/ml |
| Control 3 SD (µg/ml) | Comparable to 0.58 µg/ml | 0.47 µg/ml | 0.58 µg/ml |
| Control 3 CV% | Comparable to 2.1% | 1.4% | 2.1% |
| NCCLS Precision, Total | |||
| Control 1 Mean (µg/ml) | Comparable to 5.3 µg/ml | 5.43 µg/ml | 5.3 µg/ml |
| Control 1 SD (µg/ml) | Comparable to 0.37 µg/ml | 0.15 µg/ml | 0.37 µg/ml |
| Control 1 CV% | Comparable to 7.0% | 2.8% | 7.0% |
| Control 2 Mean (µg/ml) | Comparable to 14.3 µg/ml | 16.88 µg/ml | 14.3 µg/ml |
| Control 2 SD (µg/ml) | Comparable to 0.36 µg/ml | 0.37 µg/ml | 0.36 µg/ml |
| Control 2 CV% | Comparable to 2.5% | 2.2% | 2.5% |
| Control 3 Mean (µg/ml) | Comparable to 27.3 µg/ml | 33.27 µg/ml | 27.3 µg/ml |
| Control 3 SD (µg/ml) | Comparable to 0.78 µg/ml | 0.68 µg/ml | 0.78 µg/ml |
| Control 3 CV% | Comparable to 2.9% | 2.0% | 2.9% |
| Method Comparison (Linear Regression) | |||
| N | Comparable to N=120 | N=89 | N=120 |
| Range | Comparable to 0.30 - 41.8 µg/ml | 0.4 - 39.9 µg/ml | 0.30 - 41.8 µg/ml |
| Equation | Comparable to y=0.914x + 0.511 | $y=0.869x + 0.159$ | $y=0.914x + 0.511$ |
| Correlation (r) | Comparable to r=0.987 | r=0.976 | r=0.987 |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: For the method comparison study directly comparing the ONLINE TDM Amikacin to the COBAS INTEGRA Amikacin, the sample size was N=89. For the predicate device's method comparison (COBAS INTEGRA 700 Amikacin vs. Abbott TDx), the sample size was N=120.
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an in-vitro diagnostic assay for quantitative determination of a drug level. Ground truth is established by the reference method's result (predicate device in this case), not by expert interpretation.
4. Adjudication method for the test set
Not applicable. As noted above, this is a quantitative analytical measurement, not a subjective interpretation requiring adjudication among experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an in-vitro diagnostic instrument measuring drug concentration and does not involve "human readers" or "AI assistance" in the typical sense of image interpretation or clinical decision support systems.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies reported are for the standalone performance of the ONLINE TDM Amikacin assay. The performance characteristics like precision, lower detection limit, method comparison, specificity, and interfering substances were evaluated for the device itself.
7. The type of ground truth used
The ground truth for the performance evaluation of the ONLINE TDM Amikacin assay was established by comparison to the predicate device, the COBAS INTEGRA Amikacin assay (K991597), which itself has an established analytical performance. For the method comparison, the COBAS INTEGRA Amikacin result was the comparative truth.
8. The sample size for the training set
The document does not specify a separate "training set" with a sample size. This is common for analytical devices where fundamental chemical/biological principles are used, and "training" as in machine learning is not directly applicable. The data presented are from validation/test sets.
9. How the ground truth for the training set was established
Not applicable, as a distinct training set in the machine learning sense is not described.
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| 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). |
:
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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
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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 |
| MethodComparison | Linear Regression: ONLINE TDMAmikacin Vs. COBAS INTEGRAAmikacin (FPIA) method. | Linear Regression: COBAS INTEGRA 700Amikacin 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$ |
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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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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
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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
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§ 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.