(191 days)
Not Found
No
The summary describes a homogeneous assay utilizing particle agglutination technology and competitive binding principles, which are standard laboratory techniques and do not inherently involve AI/ML. There is no mention of AI, ML, or related concepts in the document.
No
The device is an in vitro diagnostic (IVD) assay designed to quantify zonisamide levels in human samples, which aids in managing patients treated with zonisamide. It does not directly treat or prevent a disease.
Yes
The device quantitatively determines zonisamide in human serum or plasma to aid in the management of patients treated with zonisamide, which is a diagnostic purpose.
No
The device description clearly states it is a homogeneous assay utilizing particle agglutination technology and consists of reagents (anti-Zonisamide rabbit polyclonal antibody and Zonisamide-coated microparticles), calibrators, and controls. These are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of zonisamide in human serum or plasma". This involves testing biological samples (serum or plasma) in vitro (outside the body).
- Device Description: The description details reagents and calibrators used to perform the assay on these biological samples.
- Performance Studies: The performance studies describe evaluations of the assay's accuracy, sensitivity, specificity, and precision using biological samples.
- Predicate Device: The predicate device listed (Innofluor® Phenytoin) is also an IVD, indicating the regulatory context for this type of assay.
All these elements 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, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The QMS® Zonisamide assay is intended for the quantitative determination of zonisamide in human serum or plasma on automated clinical chemistry analyzers.
Zonisamide concentrations can be used as an aid in management of patients treated with zonisamide.
The QMS Zonisamide Calibrator set is intended for use in calibration of the QMS Zonisamide assay.
The QMS® Zonisamide Control set is intended for use in quality control of the QMS Zonisamide assay.
Product codes (comma separated list FDA assigned to the subject device)
NWM, LAS, DLJ
Device Description
The QMS Zonisamide 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-Zonisamide rabbit polyclonal antibody and R2: Zonisamidecoated microparticles. A six-level set of QMS® Zonisamide Calibrators (A through F) is used to calibrate the assay. A three-level set of QMS® Zonisamide Controls (1 through 3) is used for quality control of the assay.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum or plasma
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)
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 Analytical Sensitivity or Least Detectable Dose (LDD) of the assay was determined to be 1.0 ug/mL.
The Functional Sensitivity or Limit of Quantitation (LOQ) of the assay was determined to be 3.0 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 3.0 to 50.0 µg/mL.
Method Comparison
Correlation studies were conducted using NCCLS Guideline EP9: Method Comparison and Bias Estimation Using Patient Samples as a guideline
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.
Specificity
There are two known major metabolites of zonisamide (NAZ) and sulfamoyl acetyl phenol (SMAP). Testing results indicated that there is no significant cross-reactivity for either of these metabolites.
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 crossreactivity in the QMS zonisamide assay system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity
The Analytical Sensitivity or Least Detectable Dose (LDD) of the assay was determined to be 1.0 ug/mL.
The Functional Sensitivity or Limit of Quantitation (LOQ) of the assay was determined to be 3.0 µg/mL.
Specificity
Testing results indicated that there is no significant cross-reactivity for either of these metabolites (zonisamide (NAZ) and sulfamoyl acetyl phenol (SMAP)).
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.
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
§ 862.3350 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
NOV 1 8 2005
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: K051211
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
November 18, 2005
DEVICE NAME
| Trade Name: | QMS® Zonisamide |
|---|---|
| Common Name: | Homogeneous Particle-Enhanced Turbidimetric Immunoassay |
| Device Classification: | 21 CFR 862.3350 Diphenylhydantoin Test System; Class II |
INTENDED USE
The QMS® Zonisamide assay is intended for the quantitative determination of zonisamide in human serum or plasma on automated clinical chemistry analyzers.
Zonisamide concentrations can be used as an aid in management of patients treated with zonisamide.
The QMS Zonisamide Calibrator set is intended for use in calibration of the QMS Zonisamide assay.
The QMS® Zonisamide Control set is intended for use in quality control of the QMS Zonisamide assay.
LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCY IS CLAIMED
Innofluor® Phenytoin (K955562)
DESCRIPTION OF DEVICE
The QMS Zonisamide 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-Zonisamide rabbit polyclonal antibody and R2: Zonisamidecoated microparticles. A six-level set of QMS® Zonisamide Calibrators (A through F) is used to calibrate the assay. A three-level set of QMS® Zonisamide Controls (1 through 3) is used for quality control of the assay.
1
| | Device
QMS® Zonisamide | Predicate
Innofluor® Phenytoin |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The QMS Zonisamide assay is
intended for the quantitative
determination of zonisamide in human
serum or plasma on automated
clinical chemistry analyzers. | The Innofluor Phenytoin assay is
intended for the quantitative
determination of total phenytoin. |
| Indications
for Use | Zonisamide concentrations can be
used as an aid in management of
patients treated with zonisamide. | Therapeutic drug monitoring. |
| Methodology | Homogeneous particle-enhanced
turbidimetric immunoassay (particle
agglutination) | Fluorescence Polarization
Immunoassay (FPIA) technology. |
| Reagent
Components | 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 | Three (3) reagent system:
• A Phenytoin Antiserum (Sheep)
in buffer with protein stabilizer
and Sodium azide.
• T Phenytoin Fluorescein Tracer
in buffer with protein stabilizer,
surfactant and Sodium azide
• B Pre-Treatment Buffer with
surfactant and Sodium azide |
| Calibration | QMS Zonisamide Calibrators – six
levels | Innofluor Phenytoin Calibrators –
six levels |
| Quality
Control | QMS Zonisamide Controls – three
levels | N/A |
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 Analytical Sensitivity or Least Detectable Dose (LDD) of the assay was determined to be 1.0 ug/mL.
The Functional Sensitivity or Limit of Quantitation (LOQ) of the assay was determined to be 3.0 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 3.0 to 50.0 µg/mL.
Method Comparison
Correlation studies were conducted using NCCLS Guideline EP9: Method Comparison and Bias Estimation Using Patient Samples as a guideline
2
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.
Specificity
There are two known major metabolites of zonisamide (NAZ) and sulfamoyl acetyl phenol (SMAP). Testing results indicated that there is no significant cross-reactivity for either of these metabolites.
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 crossreactivity in the QMS zonisamide assay system.
CONCLUSION
As summarized above, the QMS® Zonisamide assay is substantially equivalent to the Innofluore Phenytoin 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 8 2005
Mr. Jack Rogers Manager of Regulatory Affairs Seradyn. Inc. 7998 Georgetown Road. Suite 1000 Indianapolis, IN 46268
Re: K051211
Trade/Device Name: QMS® Zonisamide Assay QMS® Zonisamide Calibrator Set QMS® Zonisamide Control Set Regulation Number: 21 CFR 862.3350
Regulation Name: Diphenylhydantoin test system Regulatory Class: Class II Product Code: NWM, LAS, DLJ Dated: November 9, 2005 Received: November 10, 2005
Dear Mr. Rogers:
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 indictions 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, Dr 10 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, isting 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
4
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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours.
Alberto Gutt
Alberto Gutierrez, 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): K051211
QMS® Zonisamide Device Name:
Indications for Use:
The QMS Zonisamide assay is intended for the quantitative determination of zonisamide in human serum or plasma on automated clinical chemistry analyzers.
Zonisamide concentrations can be used as an aid in management of patients treated with zonisamide.
The QMS® Zonisamide Calibrator set is intended for use in calibration of the QMS Zonisamide assay.
The QMS® Zonisamide Control set is intended for use in quality control of the QMS Zonisamide assay.
Prescription Use X (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 Signoff
Office of in Vitro Diagnostic Device Evaluation and Safety
51000 K051211
Page 1 of