(175 days)
The ARCHITECT iValproic Acid assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of valproic acid, an anticonvulsant drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of valproic acid to help ensure appropriate therapy.
The ARCHITECT iValproic Acid Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of valproic acid in human serum or plasma.
The ARCHITECT iValproic Acid assay is a one-step STAT immunoassay for the quantitative measurement of valproic acid in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex. Sample, antivalproic acid coated paramagnetic microparticles, and valproic acid acridiniumlabeled conjugate are combined to create a reaction mixture. The anti-valproic acid coated microparticles bind to valproic acid present in the sample and to the valoroic acid acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is mcasured as relative light units (RLUs). An indirect relationship exists between the amount of valproic acid in the sample and the RLUs detected by the ARCHITECT i System optics.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the ARCHITECT iValproic Acid assay:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalency to AxSYM Valproic Acid assay in terms of precision. | Demonstrated through non-clinical performance data (specific value not given, but stated as meeting equivalency). |
| Substantial equivalency to AxSYM Valproic Acid assay in terms of linearity. | Demonstrated through non-clinical performance data (specific value not given, but stated as meeting equivalency). |
| Substantial equivalency to AxSYM Valproic Acid assay in terms of interferences. | Demonstrated through non-clinical performance data (specific value not given, but stated as meeting equivalency). |
| Correlation coefficient with AxSYM Valproic Acid assay. | 0.986 |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the clinical performance study (test set) or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that clinical performance demonstrated substantial equivalency with a correlation coefficient of 0.986.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided text does not include information on experts, ground truth establishment, or their qualifications for the clinical performance study. This type of information is typically not required for an immunoassay 510(k) where the comparison is against an existing, legally marketed device. The "ground truth" in this context would likely be the measurements from the predicate device itself.
4. Adjudication Method for the Test Set
The provided text does not mention any adjudication method. This is expected as the study is a comparison between two quantitative assays, not a study involving subjective interpretations that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this device is a quantitative immunoassay meant for direct measurement, not an imaging device or diagnostic tool that involves human readers interpreting results in a comparative effectiveness setting. The study focused on the analytical performance of the new assay compared to a predicate device.
6. Standalone Performance
The clinical performance summary describes the standalone performance of the ARCHITECT iValproic Acid assay by demonstrating its correlation with the predicate AxSYM Valproic Acid assay. The correlation coefficient of 0.986 directly reflects the algorithm's (immunoassay's) performance in measuring valproic acid.
7. Type of Ground Truth Used
The "ground truth" for the clinical performance study was the measurements obtained from the legally marketed predicate device, the AxSYM Valproic Acid assay. The study aimed to show substantial equivalency of the new device's measurements to those of the predicate device.
8. Sample Size for the Training Set
The provided text does not specify a sample size for the training set. Immunoassay development typically involves extensive internal validation and optimization, but the regulatory submission focuses on the performance of the final assay.
9. How the Ground Truth for the Training Set was Established
The provided text does not detail how ground truth was established for a training set. For an immunoassay, training would involve optimizing reagents, protocols, and calibration curves using known concentrations or reference materials. The "ground truth" for these processes would be the expected or known concentrations of valproic acid in standards and controls used during development and calibration, rather than expert consensus on patient data.
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AUG 0 6 2009
ARCHITECT iValproic Acid
510(k) Summary (Summary of Safety and Effectiveness)
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Applicant Name:
Judi Wallach
Regulatory Affairs Specialist
Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064
Device Name:
Reagents:
Classification Name: Valproic Acid test system Trade Name: ARCHITECT iValproic Acid Immunoassay Common Name: Valproic Acid test Governing Regulation: 862.3645 Device Classification: Class II Classification Panel: Toxicology Product Code: LEG
Calibrators:
Classification Name: Calibrator, drug specific Trade Name: ARCHITECT iValproic Acid Calibrators (A-F) Common Name: Calibrator Governing Regulation: 862.3200 Device Classification: Class II Classification Panel: Toxicology Product Code: DLJ
ARCHITECT iValproic Acid 510(k) Submission
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Legally marketed device to which equivalency is claimed:
AxSYM Valproic Acid (K941615)
Intended Use of Device:
The ARCHITECT iValproic Acid assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of valproic acid, an anticonvulsant drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of valproic acid to help ensure appropriate therapy.
Description of Device:
The ARCHITECT iValproic Acid assay is a one-step STAT immunoassay for the quantitative measurement of valproic acid in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex. Sample, antivalproic acid coated paramagnetic microparticles, and valproic acid acridiniumlabeled conjugate are combined to create a reaction mixture. The anti-valproic acid coated microparticles bind to valproic acid present in the sample and to the valoroic acid acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is mcasured as relative light units (RLUs). An indirect relationship exists between the amount of valproic acid in the sample and the RLUs detected by the ARCHITECT i System optics.
Comparison of Technological Characteristics:
The ARCHITECT iValproic Acid assay utilizes Chemiluminescent Microparticle Immunoassay (CMIA) technology for the quantitative measurement of valproic acid, an anticonvulsant drug, in human serum and plasma. The AxSYM Valproic Acid assay utilizes Fluorescence Polarization Immunoassay (FPIA) technology for the quantitative measurement of valproic acid, an anticonvulsant drug, in serum or plasma.
ARCHITECT iValproic Acid 510(k) Submission
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Summary of Non-Clinical Performance:
The ARCHITECT iValproic Acid assay is substantially equivalent to the AxSYM Valproic Acid assay in terms of precision, linearity, and interferences as demonstrated in non-clinical performance data in this 510(k) submission.
Summary of Clinical Performance:
The ARCHITECT iValproic Acid assay demonstrated substantially equivalent performance to the AxSYM Valproic Acid assay with a correlation coefficient of 0.986.
ARCHITECT íValproic Acid 510(k) Submission
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS). The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle, with its wings spread and its head turned to the left.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Abbott Laboratories Inc., Diagnostic Division c/o Ms. Judi Wallach Senior Regulatory Affairs Specialist 100 Abbott Park Road, AP6C-2, Dept 049C Abbott Park, IL 60064
Re: K090358
Trade Name: Architect iValproic Acid Immunoassay and Architect iValproic Acid Calibrators (A-F)
AUG 0 62009
Regulation Number: 21 CFR §862.3645
Regulation Name: Neuroleptic Drugs Radioreceptor Assay Test System Regulatory Class: Class II Product Codes: LEG, DLJ Dated: June 24, 2009 Received: June 25, 2009
Dear Ms. Wallach:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
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Page 2
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,
G.C.H
Courtney C. Harper, Ph.D. Acting 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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Indication for Use
510(k) Number (if known):
Device Name: ARCHITECT iValproic Acid
Indication for Use:
Reagents
The ARCHITECT iValproic Acid assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of valproic acid, an anticonvulsant drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The mcasurements obtained are used in monitoring levels of valproic acid to help ensure appropriate therapy.
Calibrators
The ARCHITECT iValproic Acid Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of valproic acid in human serum or plasma.
Prescription Use -X (Part 21 CFR 801 Subpart D)
And/Or
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Concurrence of SBDRR, Office of
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K090358
§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.