(167 days)
Not Found
No
The device description details a homogeneous immunoassay based on measuring changes in scattered light or absorbance, a standard chemical reaction method. There is no mention of AI, ML, or any computational learning processes in the description or performance studies.
No
The device is an assay for the quantitative determination of lidocaine in human serum or plasma, which is used for monitoring drug levels rather than directly treating a condition.
Yes
The device is for the quantitative determination of lidocaine in human serum or plasma, which provides information for diagnosis and management of patients.
No
The device is a laboratory assay kit that utilizes chemical reagents and microparticles to perform a quantitative determination of lidocaine. While it is used on automated analyzers, the core technology described is a chemical immunoassay, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of lidocaine in human serum or plasma". This is a diagnostic test performed on biological samples taken from the human body.
- Device Description: The description details a laboratory assay that measures a substance (lidocaine) in a biological fluid (serum or plasma) using a chemical reaction (immunoassay).
- Performance Studies: The performance studies evaluate the accuracy and reliability of the assay in measuring lidocaine levels in human samples.
- Predicate Device: The predicate device is another IVD assay (Roche COBAS INTEGRA Lidocaine Assay).
All of these characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
For the quantitative determination of lidocaine in human serum or plasma on automated clinical chemistry analyzers.
The Roche ONLINE TDM Lidocaine assay is for the quantitative determination of lidocaine in human serum or plasma on automated clinical chemistry analyzers. Lidocaine is an antiarrhythmic agent administered intravenously by either injection or continuous infusion. It is indicated in the acute management of ventricular arrhythmias such as those occurring in relation to acute myocardial infarction, or during cardiac manipulation, such as cardiac surgery. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Lidocaine reagent kits.
Product codes (comma separated list FDA assigned to the subject device)
KLR
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 lidocaine and rapidly aggregate in the presence of a lidocaine antibody solution. When a sample containing lidocaine 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 lidocaine concentration is obtained, with the maximum rate of aggregation at the lowest lidocaine 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 Lidocaine 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 Lidocaine is substantially equivalent to the currently marketed Roche COBAS INTEGRA Lidocaine Assay.
Method Comparison:
Versus Roche COBAS INTEGRA Lidocaine Assay (predicate device): N = 99, Y = 1.019X-0.044, R = 0.995, Range = 0.40 to 9.56 µg/mL
Versus FPIA method: N = 69, Y=0.947X + 0.011, R= 0.991
NCCLS Precision:
Level 1: Mean (µg/mL) 1.34, CV% (within run) 2.7, CV% (total) 6.0
Level 2: Mean (µg/mL) 4.47, CV% (within run) 1.5, CV% (total) 3.4
Level 3: Mean (µg/mL) 7.03, CV% (within run) 1.9, CV% (total) 3.6
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See Summary of Performance Studies for precision and method comparison results.
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.
Roche COBAS INTEGRA Lidocaine [K954992]
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
§ 862.3555 Lidocaine test system.
(a)
Identification. A lidocaine test system is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy.(b)
Classification. Class II.
0
JAN 1 2 2004
Roche ONLINE Lidocaine 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 Lidocaine |
| 3) Predicate device | We claim substantial equivalence to the Roche COBAS INTEGRA Lidocaine [K954992]. |
| 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 lidocaine and rapidly aggregate in the presence of a lidocaine antibody solution. When a sample containing lidocaine 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 lidocaine concentration is obtained, with the maximum rate of aggregation at the lowest lidocaine 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 lidocaine in human serum or plasma on
automated clinical chemistry analyzers. | | | | | |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|--|--|--|--|
| 6) Comparison
to predicate
device | The Roche ONLINE TDM Lidocaine 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 Lidocaine is
substantially equivalent to the currently marketed Roche COBAS INTEGRA
Lidocaine Assay. The following table presents the precision and method
comparison results. | | | | | |
| | Roche ONLINE TDM Lidocaine | Roche COBAS INTEGRA Lidocaine,
(Predicate labeling) | | | | |
| | Roche ONLINE TDM Lidocaine | Roche COBAS INTEGRA Lidocaine,
(Predicate labeling) | | | | |
|---------------------|------------------------------------------------------------------|--------------------------------------------------------|---------|---------|---------|---------|
| | Versus Roche COBAS INTEGRA Lidocaine
Assay (predicate device) | Versus FPIA method | | | | |
| | N = 99 | N = 69 | | | | |
| | $Y = 1.019X-0.044$ | $Y=0.947X + 0.011$ | | | | |
| | R = 0.995 | R= 0.991 | | | | |
| | Range = 0.40 to 9.56 µg/mL | | | | | |
| NCCLS
Precision: | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Mean (µg/mL) | 1.34 | 4.47 | 7.03 | 1.45 | 3.54 | 8.09 |
| CV% (within run) | 2.7 | 1.5 | 1.9 | 1.92 | 1.90 | 2.99 |
| CV% (total) | 6.0 | 3.4 | 3.6 | 2.30 | 2.07 | 3.75 |
2
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 features the department's name encircling a symbol. The symbol is a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The text is arranged in a circular pattern around the symbol.
Public Health Service
JAN 1 2 2004
Food and Drug Administrat 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
K032334 Re:
Trade/Device Name: Roche ONLINE TDM Lidocaine Assay Regulation Number: 21 CFR 862.3555 Regulation Name: Lidocaine test system Regulatory Class: Class II Product Code: KLR 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 ror use stated or the 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, atteres, 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 your deviloget 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 cquivalence determination does not mean r reaso be actived a determination that your device complies with other requirements of the Act that I Drillaral 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 1. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Hcalth
Enclosure
4
Roche Diagnostics Corporation
510(k) Number (if known): K032334 Device Name: Roche ONLINE TDM Lidocaine Assay Indications for Use:
The Roche ONLINE TDM Lidocaine assay is for the quantitative determination of lidocaine in human serum or plasma on automated clinical chemistry analyzes. Lidocaine is an antiarrhythmic agent administered intravenously by either injection or continuous infusion. It is indicated in the acute management of ventricular arritythmias such as those occurring in relation to acute myocardial infarction, or during cardiac manipulation, such as cardiac surgery. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Lidocaine reagent kits.
(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
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032334
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