(77 days)
Not Found
No
The summary describes a standard in vitro diagnostic reagent system for quantitative determination of a drug, with performance evaluated through traditional analytical methods like precision and method comparison. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is an in vitro diagnostic reagent system used for quantitative determination of a drug in human samples, not a therapeutic device. It aids in diagnosis and monitoring, but does not provide therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic reagent system" and that "Measurements obtained by the device are used in the diagnosis and treatment of phenytoin overdose."
No
The device is described as an "in vitro diagnostic reagent system" and is used with "automated clinical chemistry analyzers." This indicates it is a chemical reagent kit and requires hardware (the analyzers) to function, not a standalone software product.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Roche ONLINE Phenytoin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of phenytoin... in human serum or plasma..."
The "Device Description" section also reiterates this: "The Roche ONLINE Phenytoin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of phenytoin... in human serum or plasma..."
These statements clearly identify the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
For the quantitative determination of phenytoin in human serum or plasma on automated clinical chemistry analyzers.
The Roche ONLINE Phenytoin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of phenytoin, an anti-convulsant drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.
Product codes
DIP
Device Description
The Roche ONLINE Phenytoin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of phenytoin, an anti-convulsant drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin 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 Phenytoin 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 Phenytoin 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 Phenytoin Assay is substantially equivalent to the currently marketed Roche CEDIA Phenytoin II Assay.
Method comparison results:
Roche ONLINE Phenytoin versus Abbott TDx Phenytoin Assay: N = 106, Y = 0.99X-0.865, R = 0.992, Range = 1.68 to 40.0 µg/mL
Roche CEDIA Phenytoin II (Predicate) Versus Abbott TDx Phenytoin Assay: N= 108, Y=0.99X-1.43, R=0.993, Range = 1.1 to 40.0 µg/mL
NCCLS Precision:
Level 1: Mean (µg/mL) = 6.49, CV% (within run) = 2.7, CV% (total) = 6.1
Level 2: Mean (µg/mL) = 13.39, CV% (within run) = 1.4, CV% (total) = 4.5
Level 3: Mean (µg/mL) = 22.87, CV% (within run) = 1.5, CV% (total) = 4.3
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3350 Diphenylhydantoin test system.
(a)
Identification. A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.(b)
Classification. Class II.
0
APR 2 8 2003
Roche ONLINE Phenytoin 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: February 6, 2003 |
| 2) Device name | Roche ONLINE Phenytoin |
| 3) Predicate device | We claim substantial equivalence to the Roche CEDIA Phenytoin II Assay [K963840]. |
| 4) Device Description | The Roche ONLINE Phenytoin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of phenytoin, an anti-convulsant drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin 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 Phenytoin reagent kits. |
Continued on next page
1
and the comments of the country
510(k) Summary, Continued
| 5) Intended use | For the quantitative determination of phenytoin in human serum or plasma on
automated clinical chemistry analyzers. | | | | | | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|------------------------------------------|---------|---------|---------|---------|
| 6) Comparison
to predicate
device | The Roche ONLINE Phenytoin 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 Phenytoin Assay is
substantially equivalent to the currently marketed Roche CEDIA Phenytoin
II Assay. The following table presents the precision and method comparison results. | | | | | | |
| | | Roche ONLINE Phenytoin | Roche CEDIA Phenytoin II,
(Predicate) | | | | |
| | | Versus Abbott TDx Phenytoin Assay | Versus Abbott TDx Phenytoin Assay | | | | |
| | | N = 106 | N= 108 | | | | |
| | | Y = 0.99X-0.865 | Y=0.99X-1.43 | | | | |
| | | R = 0.992 | R=0.993 | | | | |
| | | Range = 1.68 to 40.0 µg/mL | Range = 1.1 to 40.0 µg/mL | | | | |
| | NCCLS
Precision: | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| | Mean (µg/mL) | 6.49 | 13.39 | 22.87 | 6.3 | 14.8 | 26.8 |
| | CV% (within run) | 2.7 | 1.4 | 1.5 | 3.2 | 2.0 | 1.3 |
| | CV% (total) | 6.1 | 4.5 | 4.3 | 5.1 | 3.1 | 2.3 |
:
:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines, suggesting a person in motion or reaching upwards. The logo is black and white.
APR 2 8 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Mike Flis Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K030428
Trade/Device Name: Roche ONLINE Phenytoin Assay Regulation Number: 21 CFR 862.3350 Regulation Name: Diphenlhydantoin Test System Regulatory Class: Class II Product Code: DIP Dated: February 6, 2003 Received: February 10, 2003
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 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 Sutman
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
4
Roche Diagnostics Corporation
Ko30428 510(k) Number (if known): Device Name: Roche ONLINE Phenytoin Assay Indications for Use:
The Roche ONLINE Phenytoin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of phenytoin, an anti-convulsant drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.
Franc
(Division Sign-Off)
Division Minical Laboratory Dev
510(k) K030428
(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)