(70 days)
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No
The description details a standard immunoassay based on chemical reactions and photometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an in-vitro diagnostic assay used for measuring topiramate levels in patient samples, which assists in diagnosing overdose and monitoring therapy. It does not actively treat or directly affect the body.
Yes
The 'Intended Use / Indications for Use' section explicitly states that "The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy." This indicates that the device provides information crucial for diagnostic purposes (identifying overdose) and guiding treatment.
No
The device is a homogeneous particle-enhanced turbidimetric immunoassay, which is a laboratory test method involving chemical reagents and physical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the assay is for the "quantitative determination of topiramate in human serum or plasma." This indicates the analysis of biological samples in vitro (outside the body).
- Purpose: The results are used "in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy." This directly relates to providing information for medical diagnosis and treatment decisions.
- Device Description: The description details a "homogeneous particle-enhanced turbidimetric immunoassay" that analyzes the sample using reagents. This is a typical method for in vitro diagnostic testing.
- Sample Type: The assay uses "human serum or plasma," which are biological specimens.
All these factors align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in the in vitro examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Seradyn QMS® Topiramate assay is intended for the quantitative determination of topiramate in human serum or plasma on automated clinical chemistry analyzers.
The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy.
Product codes
NWM
Device Description
The Seradyn QMS® Topiramate assay is a homogeneous particle-enhanced turbidimetric immunoassay. The assay is based on competition between drug in the sample and drug coated onto a micronariticle for antibody binding sites of the topiramate antibody reagent. The topiramate-coated micropariticle peagent is rapidly agglutinated in the presence of the anti-topiramate antibody reagent and in the abserved of any competing drug in the sample. The rate of absorbance change is measured photometrically. When a smale containing topiramate is added, the agglutination reaction is partially inhibited, slowing down the rate of absorbance change. A concentration-dependent classic agglutination inhibition curve can be obtained with maximum rate of agglutination at the lowest topiramate concentration and the lowest agglutination rate at the highest topiramate concentration.
The assay consists of reagents R1: anti-topiramate polyclonal antibody and R2: topiramate-ooated microparticles. A six-level set of Seradyn QMS® Topiramate Cali three-level set of Seradyn QMS® Topiramate Controls is used for quality control of the assay.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Accuracy: Accuracy by Recovery was determined by diluting the high calibrator to 12 concentrations across the assay range. The samples were analyzed in triplicate. Mean Percent Recovery was 104.6 %.
Linearity: Linearity by Dilution was determined by a study based on the NCCLS guideline EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach. All Percent Difference results were within the acceptance criteria of ±10%.
Sensitivity: The LOQ of the assay is defined as the lowest drug concentration for which acceptable inter-assay precision is observed (≤20% CV, with recovery ± 15%). The package insert claim for LOQ will be 1.5 µg/mL.
Assay Range: Based on the Accuracy, Linearity, and Sensitivity (LOQ) data, the package insert claim for the reportable range for the assay will be 1.5 to 32.0 µg/mL.
Method Comparison: A study was conducted according to NCCLS Guideline EP9-A2: Method Comparison and Bias Estimation Using Patient Samples to compare accuracy of recovery of topiramate assayed by the QMS® Topiramate assay to that of the predicate Innofluor® Topiramate assay. N = 148, Slope = 0.962, y-intercept = 0.228, R² = 0.986. Results show excellent correlation between the two assays.
Precision: A precision study was performed using the National Committee for Clinical Laboratory Standards (NCCLS) guideline EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods. Results for Control 1 (2.94 µg/mL) showed a Total CV of 4.22%, Control 2 (10.14 µg/mL) showed a Total CV of 3.37%, and Control 3 (25.69 µg/mL) showed a Total CV of 4.44%. All results were within the Acceptance Criteria of 10% error.
3) Anticoagulants: Studies showed no significant difference between the recovery of topiramate in serum or plasma. Collection tubes evaluated showed no adverse effects.
On-Board Stability:
- Calibration Curve stability: Calibration curve stability for a period of 27 days is supported by the data.
- Reagent On-Board Stability: A 60 day on-board reagent stability claim is supported by the data.
Key Metrics
Accuracy: Mean Percent Recovery = 104.6 %
Linearity: Percent Difference Acceptance Criteria = ±10%
Sensitivity (LOQ): ≤20% CV, with recovery ± 15% (Claimed LOQ = 1.5 µg/mL)
Method Comparison (Passing - Bablok parameters): Slope = 0.962, y-intercept = 0.228, R² = 0.986
Precision: Total CV
§ 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
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:
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
March 5, 2007
DEVICE NAME
| Trade Name: | Seradyn QMS® Topiramate |
|---|---|
| Common Name: | Homogeneous Particle-Enhanced Turbidimetric Immunoassay |
| Device Classification: | 21 CFR 862.3660; Phenobarbital Test System; Class II |
INTENDED USE
The Seradyn QMS® Topiramate assay is intended for the quantitative determination of topiramate in human serum or plasma on automated clinical chemistry analyzers.
The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy.
LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCY IS CLAIMED
Seradyn Innofluor® Topiramate assay K970510
DESCRIPTION OF DEVICE
The Seradyn QMS® Topiramate assay is a homogeneous particle-enhanced turbidimetric immunoassay. The assay is based on competition between drug in the sample and drug coated onto a micronariticle for antibody binding sites of the topiramate antibody reagent. The topiramate-coated micropariticle peagent is rapidly agglutinated in the presence of the anti-topiramate antibody reagent and in the abserved of any competing drug in the sample. The rate of absorbance change is measured photometrically. When a smale containing topiramate is added, the agglutination reaction is partially inhibited, slowing down the rate of absorbance change. A concentration-dependent classic agglutination inhibition curve can be obtained with maximum rate of agglutination at the lowest topiramate concentration and the lowest agglutination rate at the highest topiramate concentration.
The assay consists of reagents R1: anti-topiramate polyclonal antibody and R2: topiramate-ooated
microparticles. A six-level set of Seradyn QMS® Topiramate Cali three-level set of Seradyn QMS® Topiramate Controls is used for quality control of the assay.
MAY 1 7 2007
1
| Device | Predicate | |
|---|---|---|
| Intended Use | Seradyn QMS® Topiramate | |
| The QMS Topiramate assay is | ||
| intended for the quantitative | ||
| determination of topiramate in human | ||
| serum or plasma on automated | ||
| clinical chemistry analyzers. | Seradyn Innofluor® Topiramate | |
| The Innofluor Topiramate assay is | ||
| intended for the quantitative | ||
| determination of total topiramate in | ||
| serum or heparinized plasma by | ||
| fluorescence polarization immunoassay | ||
| (FPIA). The assay system is for use on | ||
| the TDx® or the TDxFLx® (TDx/TDxFLx) | ||
| analyzer. | ||
| Indications for Use | The measurements obtained are used | |
| in the diagnosis and treatment of | ||
| topiramate overdose and in | ||
| monitoring levels of topiramate to help | ||
| ensure appropriate therapy. | The measurements obtained are used | |
| in monitoring levels of topiramate to | ||
| ensure appropriate therapy. | ||
| Methodology | Homogeneous particle-enhanced | |
| turbidimetric immunoassay (particle | ||
| agglutination) (PETIA) | Fluorescence Polarization | |
| Immunoassay (FPIA) | ||
| Reagent | ||
| Components | Two (2) reagent system: | |
| Anti-topiramate Antibody Reagent | ||
| (R1) in buffers containing protein | ||
| stabilizers with sodium azide |
Topiramate-coated Microparticle
Reagent (R2) in buffer containing
surfactant as stabilizers with sodium
azide | Three (3) reagent system:
• Topiramate Antiserum (A) (Sheep) in
buffer with protein stabilizer and
10% error:
- . Ibuprofen
- Phenytoin .
- Tiagabine .
3) Anticoagulants
Studies were conducted to determine the performance characteristics of the assay for both serum and plasma samples containing topiramate.
The results indicate that there is no significant difference between the recovery of topiramate in serum or plasma. The collection tubes evaluated show no adverse effects on the recovery of topiramate, within the experimental error for the spiking study.
A claim for assay application to both serum and plasma samples is thus supported.
On-Board Stability
1) Calibration Curve stability
Calibration curve stability of a period of 27 days is supported by the data.
2) Reagent On-Board Stability
A 60 day on-board reagent stability claim is supported by the data.
CONCLUSION
As summarized above, the Seradyn QMS® Topiramate assay is substantially equivalent to the Seradyn Innofluor® Topiramate assay. Substantial equivalence has been demonstrated through performance testing to verify that the device functions as intended and that design specifications have been satisfied.
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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing segments, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Seradyn. Inc. c/o Mr. Jack Rogers Manager of Regulatory Affairs 7998 Georgetown Road, Suite 1000 Indianapolis, IN 46268-5620
MAY 1 7 2007
K070645 Trade/Device Name: Seradyn OMS® Topiramate Regulation Number: 21 CFR 862.3660 Regulation Name: Phenobarbital test system. Regulatory Class: Class II Product Code: NWM Dated: March 05, 2007 Received: March 08, 2007
Dear Mr. Rogers:
Re:
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 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, 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 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 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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., 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
510(k) Number (if known): K010645
Seradyn QMS® Topiramate Device Name:
Indications for Use:
The Seradyn QMS® Topiramate assay is intended for the quantitative determination of topiramate in human serum or plasma on automated clinical chemistry analyzers.
The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy.
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 Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety