(74 days)
Not Found
No
The description details a standard in vitro diagnostic immunoassay based on turbidimetry, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic test used to measure the level of lidocaine in serum or plasma, which can be used in diagnosis and treatment monitoring, but the device itself does not provide therapy.
Yes
The "Intended Use / Indications for Use" section states that "Lidocaine measurements may be used in the diagnosis and treatment of lidocaine overdose and in therapeutic drug monitoring." The "Device Description" also clearly labels it as an "in vitro diagnostic test."
No
The device is an in vitro diagnostic test consisting of prepackaged reagents and a calibrator, designed for use on a clinical chemistry system. It involves chemical reactions and turbidimetric measurements, which are hardware-dependent processes, 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 lidocaine in serum or plasma." This is a measurement of a substance in a human specimen, which is a core characteristic of an IVD. It also mentions its use in "diagnosis and treatment," further supporting its role in clinical decision-making.
- Device Description: The description of the method states it is an "in vitro diagnostic test."
- Method: The method describes a chemical assay performed on a human specimen (serum or plasma) to measure a specific substance (lidocaine). This is the definition of an in vitro diagnostic test.
- Calibrator: The calibrator is described as a "device intended for medical purposes for use on the Dimension® clinical chemistry system to establish points of parfonob to are used in determination of values in the measurement of substances in human specimens." This calibrator is used in conjunction with the lidocaine assay, and its purpose is directly related to the accurate measurement of substances in human specimens, which is an IVD function.
- Predicate Devices: The predicate devices listed are also IVDs (analytical test pack and drug calibrator).
Based on the provided text, the Dade Behring Dimension® Lidocaine (LIDO) Flex® reagent cartridge method and the associated Dade Behring Dimension® Drug Calibrator II (DC49D) are clearly intended and described as In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Dade Behring Dimension® Lidocaine (LIDO) Flex® reagent cartridge method on the Dimension® clinical chemistry system is for the quantitative determination of lidocaine in serum or plasma. Lidocaine measurements may be used in the diagnosis and treatment of lidocaine overdose and in therapeutic drug monitoring.
The Dade Behring Dimension® Drug Calibrator II (DC49D) is a device intended for medical purposes for use on the Dimension® clinical chemistry system to establish points of parfonob to are used in determination of values in the measurement of substances in human specimens.
Product codes (comma separated list FDA assigned to the subject device)
KLR, DKB
Device Description
Method: The Dade Behring Dimension® Lidocaine (LIDO) Flex® reagent cartridge method is an in vitro diagnostic test that consists of prepackaged reagents in a flexible plastic cartridge for use only on the Dimension® clinical chemistry system. The Dimension® LIDO Flex® reagent cartridge assay is based on a homogenous particle-enhanced turbition immunoassay (PETINIA) which uses a latex particle-lidocaine conjugate and monoclonal lidocaine specific antibody. Lidocaine present in the sample competes with lidocaine on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of lidocaine in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm.
Calibrator: The Dade Behring Drug Calibrator 11 (DC49D) is liquid, bovine serum base product, packaged as ten vials to a carton, with two vials at each of five levels; each vial contains 5.0 mL. This same product, the Dade Behring Drug Calibrator II (DC49C), was previously cleared (K032574) for calibration of its associated methods on the Dimension® clinical chemistry system. The product remains unchanged except for the additional value assignment for the Lidocaine constituent. The DC49D product contains the following value assigned analytes and one unassigned constituent (Quinidine): 1-Lidocaine (LIDO) 2- Acetaminophen (ACTM) 3- Carbamazepine (CRBM) 4- Digitoxin (DGTX) 5- Gentamicin (GENT) 6- N-acetylprocainamide (NAPA) 7- Procainamide (PROC) 8- Tobramycin (TOBR) 9- Valproic acid (VALP) 10- Vancomycin (VANC) Unassigned: Quinidinc
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)
Split-sample comparative performance was evaluated between the Dade Behring Dimension® LIDO Flex® method and the predicate aca® LIDO analytical test pack method.
Description: Comparative Method: Dade Behring aca® LIDO test pack
Slope: 0.985
Intercept (ug/mL): -0.037
Correlation Coefficient: 0.99
n: 120
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.
Dade Behring aca® LIDO analytical test pack [K833379], Dade Behring Dimension® Drug Calibrator II (DC49C) [K032574]
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
FEB 2 0 2004
Summary of Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name: | Richard M. Vaught
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | December 5, 2003 |
| Name of Product(s): | Dimension® Lidocaine (LIDO) Flex® reagent cartridge method and
Dimension® Drug Calibrator II (DC49D) |
| FDA Classification Name(s): | Lidocaine test system (Class II) and Calibrator (Class II) |
| Predicate Device(s): | Dade Behring aca® LIDO analytical test pack [K833379] and
Dade Behring Dimension® Drug Calibrator II (DC49C) [K032574] |
Device Description(s):
Method
The Dade Behring Dimension® Lidocaine (LIDO) Flex® reagent cartridge method is an in vitro diagnostic test that consists of prepackaged reagents in a flexible plastic cartridge for use only on the Dimension® clinical chemistry system. The Dimension® LIDO Flex® reagent cartridge assay is based on a homogenous particle-enhanced turbition immunoassay (PETINIA) which uses a latex particle-lidocaine conjugate and monoclonal lidocaine specific antibody. Lidocaine present in the sample competes with lidocaine on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of lidocaine in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm.
Calibrator
The Dade Behring Drug Calibrator 11 (DC49D) is liquid, bovine serum base product, packaged as ten vials to a carton, with two vials at each of five levels; each vial contains 5.0 mL. This same product, the Dade Behring Drug Calibrator II (DC49C), was previously cleared (K032574) for calibration of its associated methods on the Dimension® clinical chemistry system. The product remains unchanged except for the additional value assignment for the Lidocaine constituent. The DC49D product contains the following value assigned analytes and one unassigned constituent (Quinidine):
Image /page/0/Picture/10 description: The image shows the number 000005. The numbers are in a bold, sans-serif font. The numbers are black and the background is white. The image is slightly blurry.
1
1 -Lidocaine (LIDO) 2- Acetaminophen (ACTM) 3- Carbamazepine (CRBM) 4- Digitoxin (DGTX) 5- Gentamicin (GENT)
6- N-acetylprocainamide (NAPA) 7- Procainamide (PROC) 8- Tobramycin (TOBR) 9- Valproic acid (VALP) 10- Vancomycin (VANC)
Unassigned: Quinidinc
Intended Use:
Method
The Dimension® Lidocaine (LIDO) Flex® reagent cartridge method is used for the quantitative determination of lidocaine in serum or plasma. Measurements may be used in the diagnosis and treatment of lidocaine overdose, and in therapeutic drug monitoring.
Calibrator
The Dimension® Drug Calibrator II (DC49D) is intended for calibration of the above ten (10) value-assigned methods on the Dade Behring Dimension® clinical chemistry system.
Comparison to Predicate Device(s):
Method
A summary of the features of the Dade Behring Dimension® LIDO Flex® reagent cartridge method and the predicate device, the Dade Behring aca® LIDO analytical test pack (K833379) is provided in the following chart:
| Feature | Dimension® LIDO Flex® cartridge | aca® LIDO analytical test pack |
|---|---|---|
| Intended Use | in vitro diagnostice use | in vitro diagnostic use |
| Assay Range | 0.5 - 12.0 ug/mL | 1.0 - 12.0 ug/mL |
| Sample size | 6 uL | 40 uL |
| Measurement | PETINIA | |
| turbidimetric rate | ||
| 340 nm and 700nm | EMIT®1 | |
| colorimetric rate | ||
| 340 nm |
Registered trademark of Syva Company, Dade Behring Inc.
Split-sample comparative performance was evaluated between the Dade Behring Dimension® LIDO Flex® method and the predicate aca® LIDO analytical test pack method. The results are summarized below:
| Comparative
Method | Slope | Intercept
(ug/mL) | Correlation
Coefficient | n |
|-------------------------------------|-------|----------------------|----------------------------|-----|
| Dade Behring
aca® LIDO test pack | 0.985 | -0.037 | 0.99 | 120 |
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Calibrator
The Dimension Drug Calibrator II (DC49D) is identical in design and content to the currently cleared Drug Calibrator II (DC49C) product with the exception of the labeling change to identify the Lidocaine values at each level. There are no other differences in the design or manufacture of the Drug Calibrator II product.
Comments on Substantial Equivalence:
Both Dade Behring products, the Dimension® Lidocaine (LIDO) Flex® reagent cartridge method and the aca® LIDO analytical test pack method are homogenous intended for the quantitative determination of lidocaine in serum or plasma. Split-sample comparative data demonstrates good agreement (correlation) between the methods. The calibrator products are identical except the value assignments to the lidocaine constituent.
Conclusion:
The Dade Behring Dimension® Lidocaine (LIDO) Flex® reagent cartridge method and the predicate Dade Behring aca® LIDO analytical test pack method (K833379) are substantially equivalent based on their intended use and comparison performance characteristics as described above. The Dade Behring Dimension® Drug Calibrator II products (DC49C and DC49D) are identical in composition and design and are both utilized for calibration of methods on the Dimension® system.
Richard M. Vaught Regulatory Affairs and Compliance Manager December 5, 2003
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 0 2004
Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring, Inc. Chemistry/Immunochemistry Glasgow Business Community Bldg. 500 - M. S. 514; P.O. Box 6101 Newark, DE 19714
K033809 Re:
Trade/Device Name: Dimension® Lidocaine (LIDO) Flex® reagent cartridge method, and Dimension® Drug Calibrator II (DC49D) Regulation Number: 21 CFR 862.3555 Regulation Name: Lidocaine test system Regulatory Class: Class II Product Code: KLR; DKB Dated: December 5, 2003 Received: December 8, 2003
Dear Mr. Vaught:
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 abound in 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). and Oosmetter For (110) war the device, subject to the general controls provisions of the Act. The r ou may, disterer, mains 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 (sec above) into either class II (Special Controls) or class III (PMA), it If your de rice is enach additional controls. Existing major regulations affecting your device can may oe subject to sacer adon accept 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 i that FDA has made a determination that your device complies with other requirements of the Act that I Dr Areal statutes and regulations administered by other Federal agencies. You must or any I vith 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,
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, 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
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Indications For Use Statement
Device(s) Name(s):
Dimension® Lidocaine (LIDO) Flex® reagent cartridge method, and Dimension® Drug Calibrator II (DC49D)
Indications for Use:
The Dade Behring Dimension® Lidocaine (LIDO) Flex® reagent cartridge method on the Dimension® clinical chemistry system is for the quantitative determination of lidocaine in serum or plasma. Lidocaine measurements may be used in the diagnosis and treatment of lidocaine overdose and in therapeutic drug monitoring.
The Dade Behring Dimension® Drug Calibrator II (DC49D) is a device intended for medical purposes for use on the Dimension® clinical chemistry system to establish points of parfonob to are used in determination of values in the measurement of substances in human specimens.
Richard M. Vaught Regulatory Affairs and Compliance Manager
February 2, 2004
(PILEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol C. Benson
Division Sign-Off
ice of In Vitro Diagnostic Device aluation and Safety
510(k) K033809
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-counter Use_
(Optional format 1-2-96)
revised page 000004