(89 days)
Not Found
No
The summary describes a standard in vitro diagnostic assay for quantitative determination of a substance in bodily fluids, with no mention of AI/ML in the device description, intended use, or performance studies.
No
This device is for the quantitative determination of phenobarbital in human serum or plasma, used for diagnosis and monitoring, not for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital." The term "diagnosis" clearly indicates it is a diagnostic device.
No
The device is described as an "assay" and "reagent kits" used on "automated clinical chemistry analyzers," indicating it is a chemical reagent and likely involves hardware components for analysis, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of phenobarbital in human serum or plasma." This involves testing biological samples in vitro (outside the body).
- Diagnosis and Treatment: The measurements obtained are used in the "diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital." This directly relates to clinical decision-making based on laboratory test results.
- Device Description: The description reinforces that it's for quantitative determination in human serum or plasma, further confirming its use with biological samples.
- Performance Studies: The performance studies evaluate characteristics like precision and method comparison, which are standard evaluations for IVD devices.
The core function of the device is to analyze a biological sample (serum or plasma) to provide information used for diagnosis, treatment, and monitoring, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ONLINE TDM Phenobarbital assay is for the quantitative determination of phenobarbital in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital.
Product codes (comma separated list FDA assigned to the subject device)
DLZ
Device Description
The ONLINE TDM Phenobarbital assay is for the quantitative determination of phenobarbital in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital. The proposed labeling indicates the Roche Hitachi 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Phenobarbital 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Roche ONLINE TDM Phenobarbital 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 Phenobarbital assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Phenobarbital assay.
Precision:
NCCLS Precision, Within run:
Control 1: Mean (µg/ml) = 9.6, SD (µg/ml) = 0.13, CV% = 1.3
Control 2: Mean (µg/ml) = 24.1, SD (µg/ml) = 0.18, CV% = 0.7
Control 3: Mean (µg/ml) = 45.2, SD (µg/ml) = 0.37, CV% = 0.8
NCCLS Precision, Total:
Control 1: Mean (µg/ml) = 9.6, SD (µg/ml) = 0.34, CV% = 3.5
Control 2: Mean (µg/ml) = 24.1, SD (µg/ml) = 0.59, CV% = 2.4
Control 3: Mean (µg/ml) = 45.2, SD (µg/ml) = 0.82, CV% = 1.8
Method Comparison:
Linear Regression: ONLINE TDM Phenobarbital Vs. COBAS FP Phenobarbital
N=53, Range = 3.0 - 52.4 µg/ml
y = 1.047x - 0.339
r = 0.996
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 862.3660 Phenobarbital test system.
(a)
Identification. A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.(b)
Classification. Class II.
0
| 510(k) Summary | SEP 12 2007 |
|---|---|
| ---------------- | ------------- |
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 |
| 2) Device name | Proprietary name: ONLINE TDM Phenobarbital |
| | Common name: Enzyme Immunoassay, Phenobarbital |
| | Classification name: Enzyme Immunoassay, Phenobarbital |
| 3) Predicate device | We claim substantial equivalence to the currently marketed COBAS INTEGRA Phenobarbital (K951595). |
| 4) Device Description | The ONLINE TDM Phenobarbital assay is for the quantitative determination of phenobarbital in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital. The proposed labeling indicates the Roche Hitachi 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Phenobarbital reagent kits. |
Phenobarbital is one of the most commonly used drugs for the treatment of grand mal, psychomotor epilepsy, and other forms of focal epilepsy. Monitoring of the serum level of the drug is essential in order to achieve maximal seizure control while maintaining minimal blood levels to avoid negative side effects. As with other anti-convulsant drugs, it is imperative that each patient's dosage be individualized.
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The ONLINE TDM Phenobarbital assay is for the quantitative determination 5.) Intended Use of phenobarbital in human serum or plasma on Roche automated clinical chemistry analyzers.
510(k) Summary, Continued
The Roche ONLINE TDM Phenobarbital 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 Phenobarbital (K951595).
The Roche ONLINE TDM Phenobarbital 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 Phenobarbital assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Phenobarbital assay. The following table summarizes the precision and method comparison results.
Continued on next page
| | Roche COBAS Integra Phenobarbital
(Predicate) | | | Roche ONLINE TDM Phenobarbital | | |
|--------------------------------|------------------------------------------------------------|-----------|-----------|------------------------------------------------------------------------------|-----------|-----------|
| NCCLS Precision,
Within run | Control 1 | Control 2 | Control 3 | Control 1 | Control 2 | Control 3 |
| Mean (µg/ml) | 12.0 | 23.4 | 52.0 | 9.6 | 24.1 | 45.2 |
| SD (µg/ml) | 0.25 | 0.51 | 1.52 | 0.13 | 0.18 | 0.37 |
| CV% | 2.1 | 2.2 | 2.9 | 1.3 | 0.7 | 0.8 |
| NCCLS Precision,
Total | Control 1 | Control 2 | Control 3 | Control 1 | Control 2 | Control 3 |
| Mean (µg/ml) | 12.0 | 23.4 | 52.0 | 9.6 | 24.1 | 45.2 |
| SD (µg/ml) | 0.26 | 0.62 | 2.04 | 0.34 | 0.59 | 0.82 |
| CV% | 2.2 | 2.7 | 3.9 | 3.5 | 2.4 | 1.8 |
| Method
Comparison | Linear Regression: COBAS Integra
Phenobarbital Vs. FPIA | | | Linear Regression: ONLINE TDM
Phenobarbital Vs. COBAS FP
Phenobarbital | | |
| | N=206, Range = 0.8 - 60 µg/ml | | | N=53, Range = 3.0 - 52.4 µg/ml | | |
| | y = 1.036x - 1.236 | | | y= 1.047x - 0.339 | | |
| | r = 0.995 | | | r=0.996 | | |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized lines forming the body and wings.
SEP 1 2 2007
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Roche Diagnostics Corporation c/o Mr. Dimitris Demirtzoglou Regulatory Affairs Consultant 9115 Hague Road Indianapolis, IN 46250
Re: K071644 Trade/Device Name: Online TDM Phenobarbital Regulation Number: 21 CFR 862.3660 Regulation Name: Phenobarbital test system Regulatory Class: Class II Product Code: DLZ Dated: June 14, 2007 Received: June 15, 2007
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 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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indication for Use
KO71644 510(k) Number (if known):
Device Name: ONLINE TDM Phenobarbital
Indication For Use:
The ONLINE TDM Phenobarbital assay is for the quantitative determination of phenobarbital in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol C. Benson
Revision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
071644
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