(105 days)
No
The device description and performance studies focus on standard immunoassay technology and analytical performance metrics, with no mention of AI or ML.
No
This device is an in vitro diagnostic assay used for the quantitative determination of lamotrigine in human serum or plasma to aid in patient management. It measures drug levels, but does not directly treat or prevent a disease or condition, which is the definition of a therapeutic device.
Yes
The device is intended for the quantitative determination of lamotrigine in human serum or plasma to aid in the management of patients treated with lamotrigine, which is a diagnostic purpose.
No
The device description explicitly states it is a "homogeneous assay utilizing particle agglutination technology" and consists of "reagents R1: anti-Lamotrigine sheep polyclonal antibody and R2: Lamotriginecoated microparticles," indicating it is a chemical assay with physical components, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of lamotrigine in human serum or plasma". This indicates the device is used to analyze biological samples (serum or plasma) in vitro (outside the body).
- Device Description: The description details a "homogeneous assay utilizing particle agglutination technology" and mentions "reagents" and "calibrators" and "controls". These are all components and processes typical of laboratory-based diagnostic tests performed in vitro.
- Performance Studies: The performance studies describe evaluations of the assay's accuracy, linearity, sensitivity, precision, specificity, and interference, all of which are standard performance characteristics assessed for in vitro diagnostic devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K051211 QMS® Zonisamide assay) strongly suggests that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory review process for new IVDs.
- Intended User/Care Setting: "automated clinical chemistry analyzers" are instruments used in clinical laboratories to perform in vitro diagnostic tests.
All of these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QMS Lamotrigine assay is intended for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers.
Lamotrigine concentrations can be used as an aid in management of patients treated with lamotrigine.
The QMS Lamotrigine Calibrator set is intended for use in calibration of the QMS Lamotrigine assay.
The QMS® Lamotrigine Control set is intended for use in quality control of the QMS Lamotrigine assay.
Product codes
ORH, LAS, DLJ
Device Description
The QMS Lamotrigine assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle.
The assay consists of reagents R1: anti-Lamotrigine sheep polyclonal antibody and R2: Lamotriginecoated microparticles. A six-level set of QMS Lamotrigine Calibrators (A through F) is used to calibrate
the assay. A three-level set of QMS Lamotrigine Controls (1 thro the assay.
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
Accuracy and linearity were determined by a study based on the NCCLS guideline EP6: Evaluation of the Linearity of Quantitative Measurement.
The Functional Sensitivity or Limit of Quantitation (LOQ) of the assay was determined to be 2.0 µg/mL.
Based on the Accuracy, Linearity, and Sensitivity (LDD and LOQ) data, the package insert claim for the reportable range for the assay is 2.0 to 40.0 µg/mL.
Correlation studies were conducted using NCCLS Guideline EP9: Method Companison and Bias Estimation Using Patient Samples as a guideline to compare accuracy of Lamorigine
A precision study was performed using the National Committee for Clinical Laboratory Standards (NCCLS) guideline EP5: Evaluation of Precision Performance of Clinical Chemistry Devices.
There is one pharmacclogically inactive metabolite, N-2 glucuronide. Three other minor metabolites, N-5 glucuronide, N-2 oxide, and N-2 methyl have been proposed in literature. Testing results indicated that for N-2 oxide there is cross-reactivity, however, this metabolite is present in human serum in only very minor concentrations. No studies to date have been able to quantify the N-2 oxide metabolite in serum due to its extremely low concentration. Results for the other metabolites indicated that there is no significant cross-reactivity.
Interference studies were conducted using NCCLS Guideline EP7: Interference Testing in Clinical Chemistry. The results of the study indicated that of 26 drugs tested, none showed cross-reactivity in the QMS lamotrigine assay system.
Key Metrics
Functional Sensitivity or Limit of Quantitation (LOQ) = 2.0 µg/mL
Assay Range = 2.0 to 40.0 µg/mL
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3350 Diphenylhydantoin test system.
(a)
Identification. A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.(b)
Classification. Class II.
0
K062966 JAN 12 2007
510K SUMMARY
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
The assigned 510(k) number is: K062966
COMPANY/CONTACT PERSON
Seradyn, Inc 7998 Georgetown Road, Suite 1000 Indianapolis, IN 46268
Establishment registration No: 1836010
Jack Rogers Manager of Regulatory Affairs Telephone: (317) 610-3823 Fax: (317) 610-0018
DATE PREPARED
January 8, 2007
DEVICE NAME
| Trade Name: | QMS® Lamotrigine |
|---|---|
| Common Name: | Homogeneous Particle-Enhanced Turbidimetric Immunoassay |
| Device Classification: | 21 CFR 862.3350 Diphenylhydantoin Test System; Class II |
INTENDED USE
The QMS Lamotrigine assay is intended for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers.
Lamotrigine concentrations can be used as an aid in management of patients treated with lamotrigine.
The QMS Lamotrigine Calibrator set is intended for use in calibration of the QMS Lamotrigine assay.
The QMS® Lamotrigine Control set is intended for use in quality control of the QMS Lamotrigine assay.
LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCY IS CLAIMED
QMS® Zonisamide assay (K051211)
DESCRIPTION OF DEVICE
The QMS Lamotrigine assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle.
The assay consists of reagents R1: anti-Lamotrigine sheep polyclonal antibody and R2: Lamotriginecoated microparticles. A six-level set of QMS Lamotrigine Calibrators (A through F) is used to calibrate
the assay. A three-level set of QMS Lamotrigine Controls (1 thro the assay.
1
| | Device
QMS® Lamotrigine | Predicate
QMS® Zonisamide |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The QMS Lamotrigine assay is
intended for the quantitative
determination of lamotrigine in
human serum or plasma on
automated clinical chemistry
analyzers. | The QMS Zonisamide assay is
intended for the quantitative
determination of zonisamide in
human serum or plasma on
automated clinical chemistry
analyzers. |
| Indications
for Use | Lamotrigine concentrations can be
used as an aid in management of
patients treated with lamotrigine. | Zonisamide concentrations can be
used as an aid in management of
patients treated with zonisamide. |
| Methodology | Homogeneous particle-enhanced
turbidimetric immunoassay (particle
agglutination) | Homogeneous particle-enhanced
turbidimetric immunoassay (particle
agglutination) |
| Reagent
Components | Two (2) reagent system:
• Anti-Lamotrigine Antibody
Reagent (R1) in buffers
containing stabilizers with
sodium azide
• Lamotrigine-coated Microparticle
Reagent (R2) in buffer containing
stabilizers with sodium azide | Two (2) reagent system:
• Anti-Zonisamide Antibody
Reagent (R1) in buffers
containing stabilizers with
sodium azide
• Zonisamide-coated Microparticle
Reagent (R2) in buffer containing
stabilizers with sodium azide |
| Calibration | QMS Lamotrigine Calibrators - six
levels | QMS Zonisamide Calibrators - six
levels |
| Quality
Control | QMS Lamotrigine Controls - three
levels | QMS Zonisamide Controls - three
levels |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
SUMMARY OF CLINICAL TESTING
Accuracy and Linearity
Accuracy and linearity were determined by a study based on the NCCLS guideline EP6: Evaluation of the Linearity of Quantitative Measurement.
Sensitivity
The Functional Sensitivity or Limit of Quantitation (LOQ) of the assay was determined to be 2.0 µg/mL.
Assay Range
Based on the Accuracy, Linearity, and Sensitivity (LDD and LOQ) data, the package insert claim for the reportable range for the assay is 2.0 to 40.0 µg/mL.
Method Comparison
Correlation studies were conducted using NCCLS Guideline EP9: Method Companison and Bias Estimation Using Patient Samples as a guideline to compare accuracy of Lamorigine
Precision
A precision study was performed using the National Committee for Clinical Laboratory Standards (NCCLS) guideline EP5: Evaluation of Precision Performance of Clinical Chemistry Devices.
2
Specificity
There is one pharmacclogically inactive metabolite, N-2 glucuronide. Three other minor metabolites, N-5 glucuronide, N-2 oxide, and N-2 methyl have been proposed in literature. Testing results indicated that for N-2 oxide there is cross-reactivity, however, this metabolite is present in human serum in only very minor concentrations. No studies to date have been able to quantify the N-2 oxide metabolite in serum due to its extremely low concentration. Results for the other metabolites indicated that there is no significant cross-reactivity.
Interferences
Interference studies were conducted using NCCLS Guideline EP7: Interference Testing in Clinical Chemistry. The results of the study indicated that of 26 drugs tested, none showed cross-reactivity in the QMS lamotrigine assay system.
CONCLUSION
As summarized above, the QMS® Lamotrigine assay is substantially equivalent to the QMS Zonisamide assay. Substantial equivalence has been demonstrated through performance testing to verify that the device functions as intended and that design specifications have been satisfied.
3
Image /page/3/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the upper half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
JUN 0 9 2000
Seradyn Inc. C/O Mr. Jack Rogers 7998 Georgetown Road, Suite 100 Indiannapolis, IN 46268
Re: K062966
Trade/Device Name: OMS® Lamotrigine Regulation Number: 21 CFR 862.3350 Regulation Name: Diphenylhydantoin Test System Regulatory Class: Class II Product Code: ORH, LAS, DLJ Dated: December 20, 2006 Received: December 21, 2006
Dear Mr. Rogers:
This letter corrects our substantially equivalent letter of January 12, 2007.
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 (PMA). 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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 CFF). Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K012966
QMS® Lamotrigine Device Name:
Indications for Use:
The QMS® Lamotrigine assay is intended for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers.
Lamotrigine concentrations can be used as an aid in management of patients treated with lamotrigine.
The QMS® Lamotrigine Calibrator set is intended for use in calibration of the QMS Lamotrigine assay.
The QMS® Lamotrigine Control set is interded for use in quality control of the QMS Lamotrigine assay.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) K062966