(89 days)
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No
The device description details a homogeneous microparticle agglutination immunoassay using kinetic interaction of microparticles (KIMS) and competitive binding, which are standard biochemical assay techniques, not AI/ML. There is no mention of AI, DNN, or ML in the document.
No
The device is an in vitro diagnostic (IVD) assay designed to measure carbamazepine levels in serum or plasma, which is used to aid in adjusting dosage but does not directly provide therapy. It is an analytical tool rather than a therapeutic intervention.
Yes
The device is described as an "assay" for the "quantitative determination of carbamazepine in human serum or plasma" to "measure in serum or plasma the dopamine receptor blocking activity of carbamazepine" and to "aid in adjusting dosage and achieving optimal therapeutic effect while avoiding both sub-therapeutic and toxic drug levels." These functions directly support medical diagnosis and treatment monitoring.
No
The device is a reagent kit used on automated clinical chemistry analyzers, which are hardware devices. The description details a homogeneous microparticle agglutination immunoassay, which is a chemical process, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative determination of carbamazepine in human serum or plasma". This indicates the device is used to test samples taken from the human body (in vitro) to provide diagnostic information.
- Device Description: The description details a "homogeneous microparticle agglutination immunoassay" that uses "human serum or plasma" for the "detection of carbamazepine". This further confirms the in vitro nature of the testing.
- Purpose: The purpose is to "measure in serum or plasma the dopamine receptor blocking activity of carbamazepine" and to "aid in adjusting dosage and achieving optimal therapeutic effect while avoiding both sub-therapeutic and toxic drug levels." This is a clear diagnostic purpose, providing information to guide patient treatment.
The device fits the definition of an IVD as it is a medical device intended to be used in vitro for the examination of specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The ONLINE TDM Carbamazepine assay is for the quantitative determination of carbamazepine in human serum or plasma on automated clinical chemistry analyzers. In combination with other clinical information, monitoring carbamazepine levels provides physicians with an effective tool to aid in adjusting dosage and achieving optimal therapeutic effect while avoiding both sub-therapeutic and toxic drug levels. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Carbamazepine reagent kits.
The ONLINE TDM Carbamazepine assay is for the quantitative determination of carbamazepine in human serum or plasma on automated clinical chemistry analyzers. This neuroleptic drug assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of carbamazepine.
Product codes (comma separated list FDA assigned to the subject device)
KLT
Device Description
The ONLINE TDM Carbamazepine assay is for the quantitative determination of carbamazepine in human serum or plasma on automated clinical chemistry analyzers. In combination with other clinical information, monitoring carbamazepine levels provides physicians with an effective tool to aid in adjusting dosage and achieving optimal therapeutic effect while avoiding both sub-therapeutic and toxic drug levels. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Carbamazepine reagent kits.
The ONLINE TDM Carbamazepine assay is a homogeneous microparticle agglutination immunoassay. It is a two-reagent system used for the detection of carbamazepine in serum. Kinetic interaction of microparticles (KIMS) will be measured using Roche Diagnostics / Hitachi families of automated analyzers. In this technology biotinylated drug hapten serves as the binding partner to 1.) anti-carbamazepine antibody and 2.) streptavidin coated latex A competitive reaction to a limited amount of specific antibeads. carbamazepine antibody takes place between the hapten and free carbamazepine in the serum sample. A decrease in the apparent signal is proportional to the amount of drug present in the sample.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Roche ONLINE TDM Carbamazepine 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 Carbamazepine assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Carbamazepine assay. The following table summarizes the precision and method comparison results.
NCCLS Precision, Within run:
Control 1 Mean (µg/ml): 2.8, SD (µg/ml): 0.05, CV%: 1.7
Control 2 Mean (µg/ml): 8.3, SD (µg/ml): 0.13, CV%: 1.5
Control 3 Mean (µg/ml): 14.1, SD (µg/ml): 0.21, CV%: 1.5
NCCLS Precision, Total:
Control 1 Mean (µg/ml): 2.8, SD (µg/ml): 0.15, CV%: 5.6
Control 2 Mean (µg/ml): 8.3, SD (µg/ml): 0.36, CV%: 4.3
Control 3 Mean (µg/ml): 14.1, SD (µg/ml): 0.55, CV%: 3.9
Method Comparison:
Linear Regression: ONLINE TDM Carbamazepine Vs. COBAS INTEGRA Carbamazepine (FPIA) method.
N=103, Range = 0.5-11.93 µg/ml
y=1.062x - 0.16
r=0.985
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.
0
SEP 1 7 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: June 19, 2003 |
- Device name
| Proprietary name: | ONLINE TDM Carbamazepine |
|---|---|
| Common name: | Enzyme immunoassay, Carbamazepine |
| Classification name: | Neuroleptic drugs radioreceptor assay test system |
- Predicate device
| We claim substantial equivalence to the currently marketed COBAS INTEGRA Carbamazepine (K951595). | |
|---|---|
| -- | --------------------------------------------------------------------------------------------------- |
Continued on next page
1
510(k) Summary, Continued
- Device Description The ONLINE TDM Carbamazepine assay is for the quantitative determination of carbamazepine in human serum or plasma on automated clinical chemistry analyzers. In combination with other clinical information, monitoring carbamazepine levels provides physicians with an effective tool to aid in adjusting dosage and achieving optimal therapeutic effect while avoiding both sub-therapeutic and toxic drug levels. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Carbamazepine reagent kits.
The ONLINE TDM Carbamazepine assay is a homogeneous microparticle agglutination immunoassay. It is a two-reagent system used for the detection of carbamazepine in serum. Kinetic interaction of microparticles (KIMS) will be measured using Roche Diagnostics / Hitachi families of automated analyzers. In this technology biotinylated drug hapten serves as the binding partner to 1.) anti-carbamazepine antibody and 2.) streptavidin coated latex A competitive reaction to a limited amount of specific antibeads. carbamazepine antibody takes place between the hapten and free carbamazepine in the serum sample. A decrease in the apparent signal is proportional to the amount of drug present in the sample.
5.) Intended Use
The ONLINE TDM Carbamazepine assay is for the quantitative determination of carbamazepine in human serum or plasma on automated clinical chemistry analyzers.
Continued on next page
2
510(k) Summary, Continued
The Roche ONLINE TDM Carbamazepine assay is substantially equivalent 6.) Comparison to the Predicate to other products in commercial distribution intended for similar use. Most Device notably, it is substantially equivalent to the currently marketed Roche COBAS INTEGRA Carbamazepine assay (K951595).
The Roche ONLINE TDM Carbamazepine 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 Carbamazepine assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Carbamazepine assay. The following table summarizes the precision and method comparison results.
| | Roche ONLINE TDM Carbamazepine | | | Roche COBAS INTEGRA
Carbamazepine (Predicate) | | |
|----------------------|--------------------------------------------------------------------------------------------------|-----------|-----------|----------------------------------------------------------------------------------------------|-----------|-----------|
| NCCLS Precision, | Control 1 | Control 2 | Control 3 | Control 1 | Control 2 | Control 3 |
| Within run | | | | | | |
| Mean (µg/ml) | 2.8 | 8.3 | 14.1 | 3.8 | 8.6 | 14.7 |
| SD (µg/ml) | 0.05 | 0.13 | 0.21 | 0.08 | 0.17 | 0.31 |
| CV% | 1.7 | 1.5 | 1.5 | 2.2 | 1.9 | 2.1 |
| NCCLS Precision, | Control 1 | Control 2 | Control 3 | Control 1 | Control 2 | Control 3 |
| Total | | | | | | |
| Mean (µg/ml) | 2.8 | 8.3 | 14.1 | 3.8 | 8.6 | 14.7 |
| SD (µg/ml) | 0.15 | 0.36 | 0.55 | 0.12 | 0.24 | 0.52 |
| CV% | 5.6 | 4.3 | 3.9 | 3.0 | 2.8 | 3.6 |
| Method
Comparison | Linear Regression: ONLINE TDM
Carbamazepine Vs. COBAS INTEGRA
Carbamazepine (FPIA) method. | | | Linear Regression: COBAS INTEGRA
Carbamazepine Vs. commercially available
FPIA method. | | |
| | N=103, Range = 0.5-11.93 µg/ml
$y=1.062x - 0.16$
$r=0.985$ | | | N=205, Range = 1.6-19.6 µg/ml
$y=1.061x - 0.124$
$r=0.995$ | | |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows a stylized drawing of a bird in flight. The bird is depicted with thick, curved lines, giving it a sense of movement and energy. The bird is surrounded by a dotted circle, which may represent a halo or an aura.
SEP 1 7 2003
98 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: K031902
Trade/Device Name: ONLINE TDM Carbamazepine Assay Regulation Number: 21 CFR 862.3645 Regulation Name: Neuroleptic drugs radioreceptor assay test system Regulatory Class: Class II Product Code: KLT Dated: June 19, 2003 Received: June 20, 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, 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). 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 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
5
Indications for Use Statement
| 510(k) Number (if known): | K031902 |
|---|---|
| Device Name: | Roche Diagnostics ONLINE TDM Carbamazepine |
| Indications for Use: | The ONLINE TDM Carbamazepine assay is for the quantitative determination of carbamazepine in human serum or plasma on automated clinical chemistry analyzers. This neuroleptic drug assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of carbamazepine. |
(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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K031902
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・
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