(80 days)
The ARCHITECT iDigoxin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of digoxin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used to aid in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to help ensure appropriate therapy.
The ARCHITECT iDigoxin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of digoxin in human serum or plasma.
For in vitro diagnostic use.
The ARCHITECT iDigoxin assay is a one-step STAT immunoassay for the quantitative measurement of digoxin in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex. Sample, antidigoxin coated paramagnetic microparticles, assay diluent, and digoxiqenin acridinium-labeled conjugate are combined to create a reaction mixture. The antidigoxin coated microparticles bind to digoxin present in the sample and to the digoxigenin acridinium-labeled conjugate. After washing, pre-trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of digoxin in the sample and the RLUs detected by the ARCHITECT i System optics.
- Acceptance Criteria and Reported Device Performance:
The provided document describes a 510(k) submission for the ARCHITECT iDigoxin assay, claiming substantial equivalence to a predicate device. The primary performance metric reported is based on this equivalence.
| Acceptance Criteria | Reported Device Performance | Metric Type |
|---|---|---|
| Substantial Equivalence to predicate device (Aeroset Multigent Digoxin) | Pearson correlation coefficient of 0.993 | Correlation Coefficient |
- Sample Size for Test Set and Data Provenance:
The document does not explicitly state the sample size used for the clinical performance study or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "non-clinical performance data" and "clinical performance data" without specifying details about the clinical study itself.
- Number and Qualifications of Experts for Ground Truth:
The document does not mention the use of experts to establish ground truth for the test set. For in vitro diagnostic devices like the ARCHITECT iDigoxin, the ground truth is typically clinical samples analyzed by a reference method or the predicate device itself, rather than expert interpretation of images or clinical scenarios.
- Adjudication Method:
The document does not mention any adjudication method, as it doesn't describe a scenario where expert consensus or conflict resolution would be required. The clinical performance is assessed by comparing results to a predicate device.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not performed or described. This type of study is typically relevant for interpretative devices where human readers assess cases (e.g., radiology images). The ARCHITECT iDigoxin is a quantitative immunoassay, not an interpretative device, so an MRMC study is not applicable. Therefore, there is no effect size reported for human readers with and without AI assistance.
- Standalone (Algorithm Only) Performance:
The device itself is a standalone algorithm (an immunoassay system). The "performance" section describes the device's ability to measure digoxin levels in comparison to a predicate device. So, the clinical performance reported (Pearson correlation coefficient of 0.993) is the standalone performance of the ARCHITECT iDigoxin assay against the predicate device.
- Type of Ground Truth Used:
For the clinical performance study, the "ground truth" was established by the measurements obtained from the legally marketed predicate device, Aeroset Multigent Digoxin. The ARCHITECT iDigoxin's readings were correlated with the readings from this established device.
- Sample Size for Training Set:
The document does not explicitly state the sample size used for any training set. For an immunoassay, "training" might involve calibrating the system and optimizing reagents, but details on sample sizes for these internal processes are not provided in this regulatory summary.
- How Ground Truth for Training Set was Established:
The document does not explicitly describe how ground truth for a training set was established. Immunoassays are typically "trained" or calibrated using a series of calibrator materials with known concentrations. The ARCHITECT iDigoxin Calibrators (A-F) are mentioned, which would be used for the calibration process. The ground truth for these calibrators would be established through a traceable reference method by the manufacturer.
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DEC 2 2 2008
ARCHITECT iDigoxin
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.
The assigned 510(k) number is: 10 82953
Preparation Date:
Applicant Name:
Mr. Joan Guixer Director of Quality Assurance and Regulatory Affairs Biokit S.A. Lliça d'Amunt Barcelona, Spain 08186
Device Name:
Reagents Classification Name: digoxin test system Trade Name: ARCHITECT iDigoxin Immunoassay Common Name: digoxin test system Governing Requlation: 862.3320 Device Classification: Class II Classification Panel: Toxicology Product Code: KXT
Calibrators: Classification Name: Calibrator, drug specific Trade Name: ARCHITECT /Digoxin Calibrators (A-F) Common Name: Calibrator Governing Requlation: 862.3200 Device Classification: Class II Classification Panel: Toxicology Product Code: DLJ
Legally marketed device to which equivalency is claimed: Aeroset Multigent Digoxin (K023058)
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Intended Use of Device:
The ARCHITECT /Digoxin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of digoxin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used to aid in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to help ensure appropriate therapy.
The ARCHITECT iDigoxin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of digoxin in human serum or plasma.
Description of Device:
The ARCHITECT iDigoxin assay is a one-step STAT immunoassay for the quantitative measurement of digoxin in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex. Sample, antidigoxin coated paramagnetic microparticles, assay diluent, and digoxiqenin acridinium-labeled conjugate are combined to create a reaction mixture. The antidigoxin coated microparticles bind to digoxin present in the sample and to the digoxigenin acridinium-labeled conjugate. After washing, pre-trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of digoxin in the sample and the RLUs detected by the ARCHITECT i System optics.
Comparison of Technological Characteristics:
The ARCHITECT Digoxin assay is a chemiluminescent microparticle immunoassay (CMIA) method for the quantitative measurement of of digoxin in human serum or plasma. The Aeroset Multigent Digoxin assay is a homogeneous particle-enhanced turbidimetric immunoassay (PETIA) used for the analysis of digoxin in serum or plasma.
Summary of Non-Clinical Performance:
The ARCHITECT iDigoxin assay is substantially equivalent to the Aeroset Multigent Digoxin 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 iDigoxin demonstrated substantially equivalent performance to the Aeroset Multigent Digoxin with a Pearson correlation coefficient of 0.993.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 2 2008
BioKit S.A. c/o Mr. John Guixer Quality Assurance and Regulatory Affairs Director Can Malé s/n Lliçà d'Amunt, Barcelona, 08186, Spain
Re: K082953
Trade Name: Architect iDigoxin Reagents, Architect iDigoxin Calibrator Regulation Number: 21 CFR 862.3320 Regulation Name: Digoxin Test System. Regulatory Class: Class II Product Codes: KXT, DLJ Dated: September 30, 2008 Received: October 06, 2008
Dear Mr. Guixer:
We have reviewed your Scction 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 10gally marketed predicate device results in a classification for your device and thus, rerroits 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 trom the (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yéan 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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Indication for Use
510(k) Number (if known):
Device Name: ARCHITECT iDigoxin Reagents and ARCHITECT iDigoxin Calibrators (A-F)
Indication for Use:
Reagents
The ARCHITECT iDigoxin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of digoxin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used to aid in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to help ensure appropriate therapy.
Calibrators
The ARCHITECT iDigoxin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of digoxin in human serum or plasma.
For in vitro diagnostic use.
Prescription Use × (Part 21 CFR 801 Subpart D) 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 Devices (OIVD)
Carol Bensen
Sign-Off
്ce of In Vitro Diagnostic Device ation and Safety
K082953_
§ 862.3320 Digoxin test system.
(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.