(130 days)
Not Found
Roche/Hitachi 911, Roche/Hitachi 912, Roche/Hitachi 917, Modular P, COBAS INTEGRA 700, COBAS FARA II Gentamicin assay
No
The summary describes a standard in vitro diagnostic reagent system for quantitative determination of a drug. There is no mention of AI, ML, or any computational methods that would suggest their use in the analysis or interpretation of results beyond standard analytical chemistry techniques.
No
This device is an in vitro diagnostic reagent system used for quantitative determination of gentamicin in human serum or plasma, which is used for diagnosis and monitoring, not for direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostic reagent system" and that its measurements are "used in the diagnosis and treatment of gentamicin overdose".
No
The device is described as an "in vitro diagnostic reagent system" and is used with "automated clinical chemistry analyzers," indicating it is a physical reagent kit and not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it's an "in vitro diagnostic reagent system" and is used for the "quantitative determination of gentamicin... in human serum or plasma." It also mentions its use in "diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin." These are all hallmarks of an IVD.
- Device Description: The description reiterates that it's an "in vitro diagnostic reagent system."
- Performance Studies: The performance studies focus on evaluating the device's ability to accurately measure gentamicin in biological samples, which is the core function of an IVD.
The information provided clearly indicates that this device is designed to be used outside of the human body to examine specimens (serum or plasma) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Roche ONLINE Gentamicin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
Product codes
LCD
Device Description
The Roche ONLINE Gentamicin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Gentamicin reagent kits.
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
The Roche ONLINE Gentamicin 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 Gentamicin Assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Gentamicin Assay.
Method Comparison:
Roche/Hitachi 917 versus Gentamicin assay on the COBAS INTEGRA 700: N = 112, Y = 1.104x - 0.022, R = 0.984, Range = 0.17 to 7.81 µg/mL
Versus COBAS FARA II Gentamicin assay (Predicate): N= 145, Y = 1.025x - 0.029, R = 0.998, Range = 0.5 to 10.0 µg/mL
Precision:
Level 1: Mean (µg/mL) = 3.36, CV% (within run) = 1.0, CV% (total) = 2.9
Level 2: Mean (µg/mL) = 6.26, CV% (within run) = 0.9, CV% (total) = 3.2
Level 3: Mean (µg/mL) = 7.96, CV% (within run) = 0.7, CV% (total) = 2.7
Key Metrics
Not Found
Predicate Device(s)
COBAS INTEGRA Gentamicin Assay
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3450 Gentamicin test system.
(a)
Identification. A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.(b)
Classification. Class II.
0
KC020704
JUL 12 2002
Roche ONLINE Gentamicin Assay
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) 845-2000 | |
| Contact Person: Mike Flis | |
| Date Prepared: Februray 27, 2002 | |
| 2) Device name | Roche ONLINE Gentamicin |
| 3) Predicate device | We claim substantial equivalence to the COBAS INTEGRA Gentamicin Assay. |
| 4) Device Description | The Roche ONLINE Gentamicin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Gentamicin reagent kits. |
Continued on next page
1
510(k) Summary, Continued
comparison results.
1 - 12
| 5) Intended use | For the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers. |
|---|---|
| 6) Comparison to predicate device | The Roche ONLINE Gentamicin 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 Gentamicin Assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA |
| Roche ONLINE Gentamicin | | | | Roche COBAS INTEGRA Gentamicin,
(Predicate) | | |
|-----------------------------------------------------------------------|---------|---------|---------|------------------------------------------------|---------|---------|
| Roche/Hitachi 917 versus Gentamicin assay on
the COBAS INTEGRA 700 | | | | Versus COBAS FARA II Gentamicin
assay | | |
| N = 112 | | | | N= 145 | | |
| Y = $1.104x - 0.022$ | | | | Y = $1.025x - 0.029$ | | |
| R = 0.984 | | | | R = 0.998 | | |
| Range = 0.17 to 7.81 µg/mL | | | | Range = 0.5 to 10.0 µg/mL | | |
| Precision: | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Mean (µg/mL) | 3.36 | 6.26 | 7.96 | 1.4 | 4.0 | 4.9 |
| CV% (within run) | 1.0 | 0.9 | 0.7 | 3.0 | 1.9 | 2.1 |
| CV% (total) | 2.9 | 3.2 | 2.7 | 3.4 | 1.8 | 2.1 |
Gentamicin Assay. The following table presents the precision and method
comparison results.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three curved lines representing the eagle's head and wings. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
.JUI 12 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Mike Flis Regulatory Affairs Principle 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
K020704 Re:
Trade/Device Name: Roche ONLINE Gentamicin Assay Regulation Number; 21 CFR 862.3450 Regulation Name: Gentamicin test system Regulatory Class: Class II Product Code: LCD Dated: June 7, 2002 Received: June 10, 2002
Dear Mr. Flis:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Roche Diagnostics Corporation
510(k) Number (if known): Device Name: Roche ONLINE Gentamicin Assay Indications for Use:
The Roche ONLINE Gentamicin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
eom
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020704
(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) $\checkmark$
OR
Over-The-Counter Use
(Optional Format 1-2-96)