(65 days)
Not Found
No
The description details a homogeneous enzyme immunoassay technique for quantitative analysis, which is a standard biochemical method and does not involve AI or ML. The "Mentions AI, DNN, or ML" section is also explicitly marked as "Not Found".
No.
The device is an in vitro diagnostic (IVD) assay used to measure vancomycin levels, which aids in diagnosis and treatment monitoring, but it does not directly provide therapy.
Yes
Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose.
No
The device description clearly states it is an "assay" and a "reagent kit" used on automated clinical chemistry analyzers, indicating it is a chemical/biological product and not solely software.
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 assay is for the quantitative determination of vancomycin in human serum or plasma. It also mentions that the measurements are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy. These are all activities performed on biological samples in vitro (outside the body) for diagnostic or therapeutic monitoring purposes.
- Device Description: The description details a laboratory assay based on a homogeneous enzyme immunoassay technique performed on automated clinical chemistry analyzers. This is a typical setup for an in vitro diagnostic test.
- Performance Studies: The document describes performance studies evaluating characteristics like precision, lower detection limit, and method comparison, which are standard evaluations for IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K954992) and the name "COBAS INTEGRA Vancomycin" strongly indicates that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for demonstrating substantial equivalence to already cleared IVDs.
Therefore, based on the provided information, the ONLINE TDM Vancomycin assay clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ONLINE TDM Vancomycin assay is for the quantitative determination of vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.
Product codes
LEH
Device Description
The ONLINE TDM Vancomycin assay is for the quantitative determination of vancomycin 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 Vancomycin reagent kits. The assay is based on a homogeneous enzyme immunoassay technique used for the quantitative analysis of vancomycin in human serum or plasma. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme functions only with the bacterial (Leuconostoc mesenteroids) enzyme employed in 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
The Roche ONLINE TDM Vancomycin 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 Vancomycin assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Vancomycin assay. The precision and method comparison results are summarized in tables.
Key Metrics
NCCLS Precision, Within run
Control 1: Mean (µg/ml) 6.8, SD (µg/ml) 0.34, CV% 4.9
Control 2: Mean (µg/ml) 21.0, SD (µg/ml) 0.29, CV% 1.4
Control 3: Mean (µg/ml) 39.1, SD (µg/ml) 0.45, CV% 1.1
NCCLS Precision, Total
Control 1: Mean (µg/ml) 6.8, SD (µg/ml) 0.40, CV% 5.8
Control 2: Mean (µg/ml) 21.0, SD (µg/ml) 0.60, CV% 2.9
Control 3: Mean (µg/ml) 39.1, SD (µg/ml) 1.04, CV% 2.7
Method Comparison
Linear Regression: ONLINE TDM Carbamazepine Vs. COBAS INTEGRA Carbamazepine (FPIA) method.
N=55, Range = 5.0-67.2 µg/ml
y=1.038x - 0.094
r=0.991
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3950 Vancomycin test system.
(a)
Identification. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.(b)
Classification. Class II.
0
Ko60586
MAY 11 2006
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 |
| | Date Prepared: February 28, 2006 |
| 2) Device name | Proprietary name: ONLINE TDM Vancomycin |
| | Common name: Enzyme Immunoassay, Vancomycin |
| | Classification name: RADIOIMMUNOASSAY, VANCOMYCIN |
| 3) Predicate device | We claim substantial equivalence to the currently marketed COBAS INTEGRA Vancomycin (K954992). |
:
Continued on next page
:
1
510(k) Summary, Continued
- Device The ONLINE TDM Vancomycin assay is for the quantitative Description determination of vancomycin 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 Vancomycin reagent kits. The assay is based on a homogeneous enzyme immunoassay technique used for the quantitative analysis of vancomycin in human serum or plasma.8 The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme functions only with the bacterial (Leuconostoc mesenteroids) enzyme employed in the assay. 5.) Intended The ONLINE TDM Vancomycin assay is for the quantitative Use determination of vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers. Continued on next page
2
510(k) Summary, Continued
The Roche ONLINE TDM Vancomycin 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 Vancomycin assay (K954992).
The Roche ONLINE TDM Vancomycin 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 Vancomycin assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Vancomycin assay. The following table summarizes the precision and method comparison results.
| | Roche ONLINE TDM Vancomycin | | | Roche COBAS INTEGRA Vancomycin
(Predicate) | | |
|--------------------------------|--------------------------------------------------------------------------------------------------|-----------|-----------|----------------------------------------------------------------------------|-----------|-----------|
| NCCLS Precision,
Within run | Control 1 | Control 2 | Control 3 | Control 1 | Control 2 | Control 3 |
| Mean (µg/ml) | 6.8 | 21.0 | 39.1 | 3.8 | 8.6 | 14.7 |
| SD (µg/ml) | 0.34 | 0.29 | 0.45 | 0.08 | 0.17 | 0.31 |
| CV% | 4.9 | 1.4 | 1.1 | 2.2 | 1.9 | 2.1 |
| NCCLS Precision,
Total | Control 1 | Control 2 | Control 3 | Control 1 | Control 2 | Control 3 |
| Mean (µg/ml) | 6.8 | 21.0 | 39.1 | 3.8 | 8.6 | 14.7 |
| SD (µg/ml) | 0.40 | 0.60 | 1.04 | 0.12 | 0.24 | 0.52 |
| CV% | 5.8 | 2.9 | 2.7 | 3.0 | 2.8 | 3.6 |
| Method
Comparison | Linear Regression: ONLINE TDM
Carbamazepine Vs. COBAS INTEGRA
Carbamazepine (FPIA) method. | | | Linear Regression: COBAS INTEGRA
Carbamazepine (FPIA) Vs. COBAS FARA II | | |
| | N=55, Range = 5.0-67.2 µg/ml
y=1.038x - 0.094
r=0.991 | | | N=193, Range = 1.41-68.1 µg/ml
y=0.958x - 0.386
r=0.995 | | |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Dimitris Demirtzoglou Regulatory Affairs Consultant Roche Diagnostic Corp. 9115 Hague Rd. Indianapolis, IN 46250
MAY 1 1 2006
Re: K060586
Trade/Device Name: ONLINE TDM Vancomycin Regulation Number: 21 CFR8862.3950 Regulation Name: Vancomycin test system Regulatory Class: Class II Product Code: LEH Dated: March 6, 2006 Received: March 7. 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 no 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).
4
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 mber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Alberto G
Alberto Gutie PhD
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):
60586
Device Name: ONLINE TDM Vancomycin
Indications For Use:
The ONLINE TDM Vancomycin assay is for the quantitative determination of vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin 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)
A.C.W.
Not Valid Sign-Off
Office of In Vitro Diagnostic Device Brunnerion and Salery
Page 1 of
L060586