(167 days)
Not Found
No
The device description details a homogeneous immunoassay based on measuring changes in scattered light or absorbance. There is no mention of AI or ML in the intended use, device description, or the sections specifically checked for these terms. The performance studies focus on traditional analytical performance metrics for an immunoassay.
No
This device is for the quantitative determination of quinidine in human serum or plasma, which is a diagnostic purpose, not a therapeutic one. It measures drug levels to guide treatment, but does not itself treat or cure a disease.
Yes
This device is designed for the quantitative determination of quinidine in human serum or plasma to monitor drug levels for therapeutic purposes, which falls under the definition of a diagnostic device.
No
The device description clearly outlines a homogeneous immunoassay based on measuring changes in scattered light or absorbance using microparticles and antibodies, which are physical components and chemical reactions, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of quinidine in human serum or plasma". This involves testing biological samples (serum or plasma) in vitro (outside the body) to obtain diagnostic information (the concentration of quinidine).
- Device Description: The description details a laboratory assay that analyzes the interaction of reagents with components in the patient's sample. This is a hallmark of an in vitro diagnostic test.
- Performance Studies: The performance studies evaluate the device's ability to accurately measure quinidine in samples, which is essential for an IVD.
- Predicate Device: The predicate device is also an "Assay," further indicating that this device falls under the category of in vitro diagnostics.
The core function of the device is to analyze a biological sample in vitro to provide information about a patient's condition (quinidine levels for therapeutic drug monitoring), which aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the quantitative determination of quinidine in human serum or plasma on automated clinical chemistry analyzers.
The Roche ONLINE TDM Quinidine assay is for the quantitative determination of quinidine in human serum or plasma on automated clinical chemistry analyzers. Quinidine is used for the numan sorant of practicular arththmias, junctional (nodal) arrhythmias, and supraventricular (atrial) arrhythmias. The quinidine dosage required to achieve therapeutic supraventicular (urrry annos) formulation, patient age, and individual variability in 2010, 0 Scruit levels is depondent on the proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Quinidine reagent kits.
Product codes
LBZ
Device Description
The assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with quinidine and rapidly aggregate in the presence of a quinidine antibody solution. When a sample containing quinidine is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formulation is inhibited. Thus, a classic inhibition curve with respect to quinidine concentration is obtained, with the maximum rate of aggregation at the lowest quinidine concentration. By monitoring the change in scattered light or absorbance, a concentration-dependent curve is obtained.
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 Quinidine 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 Quinidine is substantially equivalent to the currently marketed Roche COBAS INTEGRA Quinidine Assay.
Method comparison:
Versus Roche COBAS INTEGRA Quindine Assay (predicate device): N = 150, Y = 1.054X-0.036, R = 0.991, Range = 0.22 to 7.04 µg/mL
Versus Enzyme Immunoassay (Predicate labeling): N = 154, Y = 0.941X - 0.024, R = 0.991, Range = 0.16 to 5.7 µg/mL
Precision (NCCLS):
Level 1: Mean (µg/mL) = 0.93, CV% (within run) = 2.0, CV% (total) = 3.9
Level 2: Mean (µg/mL) = 2.87, CV% (within run) = 1.3, CV% (total) = 2.7
Level 3: Mean (µg/mL) = 4.61, CV% (within run) = 1.2, CV% (total) = 2.7
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3320 Digoxin test system.
(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.
0
JAN 1 2 2004
Roche ONLINE Quinidine 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: July 28, 2003 |
| 2) Device name | Roche ONLINE TDM Quinidine |
| 3) Predicate device | We claim substantial equivalence to the Roche COBAS INTEGRA Quinidine [K951595]. |
| 4) Device Description | The assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with quinidine and rapidly aggregate in the presence of a quinidine antibody solution. When a sample containing quinidine is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formulation is inhibited. Thus, a classic inhibition curve with respect to quinidine concentration is obtained, with the maximum rate of aggregation at the lowest quinidine concentration. By monitoring the change in scattered light or absorbance, a concentration-dependent curve is obtained. |
Continued on next page
1
510(k) Summary, Continued
.
.
:
| 5) Intended use | For the quantitative determination of quinidine in human serum or plasma on automated clinical chemistry analyzers. |
|---|---|
| 6) Comparison to predicate device | The Roche ONLINE TDM Quinidine 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 Quinidine is substantially equivalent to the currently marketed Roche COBAS INTEGRA Quinidine Assay. The following table presents the precision and method comparison results. |
| Roche ONLINE TDM Quinidine | Roche COBAS INTEGRA Quinidine, |
|---|---|
| ---------------------------- | -------------------------------- |
.
and the control control control control controllers.
: .
| Roche ONLINE TDM Quinidine | | | Roche COBAS INTEGRA Quinidine,
(Predicate labeling) | | | |
|-----------------------------------------------------------------|---------|---------|--------------------------------------------------------|---------|---------|---------|
| Versus Roche COBAS INTEGRA Quindine
Assay (predicate device) | | | Versus Enzyme Immunoassay | | | |
| N = 150 | | | N = 154 | | | |
| Y = $1.054X-0.036$ | | | Y = $0.941X - 0.024$ | | | |
| R = 0.991 | | | R = 0.991 | | | |
| Range = 0.22 to 7.04 µg/mL | | | Range = 0.16 to 5.7 µg/mL | | | |
| NCCLS
Precision: | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Mean (µg/mL) | 0.93 | 2.87 | 4.61 | 1.35 | 3.47 | 5.42 |
| CV% (within run) | 2.0 | 1.3 | 1.2 | 2.1 | 2.2 | 2.0 |
| CV% (total) | 3.9 | 2.7 | 2.7 | 3.2 | 3.5 | 3.2 |
and the comments of the comments of the comments of
:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized eagle with three stripes on its wing, representing health, hope, and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
JAN 1 2 2004
Mr. Mike Flis Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, In 46250-0457
K032332 Re:
Trade/Device Name: Roche ONLINE TDM Quinidine Assay Regulation Number: 21 CFR 862.3320 Regulation Name: Digoxin test system Regulatory Class: Class II Product Code: LBZ Dated: October 31, 2003 Received: November 4, 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 for associor 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 r ou may, ateres 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 r hat 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 of any I edolul statuates and 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).
3
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 Putman
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
510(k) Number (if known): 510(R) Name: Roche ONLINE TDM Quinidine Assay Indications for Use:
The Roche ONLINE TDM Quinidine assay is for the quantitative determination of quinidine in human serum or plasma on automated clinical chemistry analyzers. Quinidine is used for the numan sorant of practicular arththmias, junctional (nodal) arrhythmias, and supraventricular (atrial) arrhythmias. The quinidine dosage required to achieve therapeutic supraventicular (urrry annos) formulation, patient age, and individual variability in 2010, 0 Scruit levels is depondent on the proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Quinidine reagent kits.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE W NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use ______ |
|---|---|---|
| --------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------- |
| Division Sign-Off | (Optional Format 1-2-96) |
|---|---|
| ------------------- | -------------------------- |
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032332