(175 days)
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No
The description focuses on a standard immunoassay technology (CMIA) and does not mention any AI or ML components in the device's operation or data analysis.
No
The device is an in vitro diagnostic (IVD) assay designed to measure valproic acid levels in patient samples, which is used for monitoring drug levels to help ensure appropriate therapy, not for treating a condition itself.
Yes
The device measures valproic acid levels in human serum or plasma for monitoring therapy, which is a diagnostic purpose to ensure appropriate treatment.
No
The device description clearly outlines a chemiluminescent microparticle immunoassay (CMIA) which involves physical reagents and a system (ARCHITECT i System) to perform the assay and measure results. This is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is "in vitro" and is used for the quantitative measurement of valproic acid in human serum or plasma. This is a key characteristic of an IVD.
- Device Description: The description details a laboratory-based assay using chemical reactions (chemiluminescent microparticle immunoassay) to analyze a biological sample (human serum or plasma). This is consistent with the nature of an IVD.
- Measurement of a Substance in a Biological Sample: The device measures the level of valproic acid in human serum or plasma, which are biological samples. This is a core function of many IVDs.
- Purpose of Measurement: The measurements are used "in monitoring levels of valproic acid to help ensure appropriate therapy," indicating a diagnostic or monitoring purpose related to a patient's health.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LEG, DLJ
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
The ARCHITECT iValproic Acid assay demonstrated substantially equivalent performance to the AxSYM Valproic Acid assay with a correlation coefficient of 0.986.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.
0
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
1
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
2
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
3
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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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
5
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