(193 days)
Not Found
No
The description focuses on standard immunoassay technology (CMIA) and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic assay used for quantitative determination of gentamicin in human serum or plasma, which aids in the diagnosis and treatment of gentamicin overdose and monitoring therapy. It does not directly treat or prevent a disease.
Yes
The intended use explicitly states that the measurements obtained from this device are "used in the diagnosis and treatment of gentamicin overdose."
No
The device description clearly outlines a chemiluminescent microparticle immunoassay (CMIA) which involves physical reagents (microparticles, conjugate, solutions) and a system (ARCHITECT i System) to measure light units. 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/Indications for Use: The description explicitly states "in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of gentamicin... in human serum or plasma". This clearly indicates that the test is performed outside of the body using biological samples.
- Device Description: The description details the process of combining sample, reagents, and measuring a reaction, which is characteristic of an in vitro diagnostic test.
- Purpose: The intended use states the measurements are used "in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy." This aligns with the purpose of IVDs, which are used to provide information for diagnosis, monitoring, or treatment decisions.
N/A
Intended Use / Indications for Use
The ARCHITECT iGentamicin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.
The ARCHITECT iGentamicin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma.
Product codes
LCD, DLJ
Device Description
The ARCHITECT iGentamicin assay is a one-step immunoassay for the quantitative determination of gentamicin in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex. In the ARCHITECT iGentamicin assay, sample, anti-gentamicin coated paramagnetic microparticles, and gentamicin acridinium-labeled conjugate are combined to create a reaction mixture. The anti-gentamicin coated microparticles bind to the gentamicin present in the sample and to the acridinium-labeled conjugate. After washing, pre-trigger and 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 gentamicin 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
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Not Found
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
The analytical performance of the ARCHITECT iGentamicin assay was demonstrated through the following studies, which are provided in this 510(k) submission:
- . Precision
- Limit of Blank, Limit of Detection, and Limit of Quantitation (Sensitivity) .
- . Linearity
- Interferences
- Recovery .
- Manual Dilution .
- Matrix Comparison (Tube Type) ●
- Method Comparison (Correlation) .
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3450 Gentamicin test system.
(a)
Identification. A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.(b)
Classification. Class II.
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Kl02699
Admin 3.0 510(k) Summary (Summary of Safety and Effectiveness)
APR - 1 2011
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:
Judith Wallach, Regulatory Affairs Administrator Regulatory Affairs Abbott Laboratories Diagnostics Division Dept. 9V6 AP6C-2 100 Abbott Park Road Abbott Park, IL 60064
Device Name:
Reagent Kit: Classification Name: Gentamicin test system Trade Name: ARCHITECT iGentamicin Common Name: Gentamicin Governing Regulation: 862.3450 Device Classification: Class II Classification Panel: Clinical Toxicology Code: LCD
ARCHITECT iGentamicin Calibrator Kit Classification Name: Calibrators, Drug Specific Trade Name: ARCHITECT iGentamicin Calibrators (A-F) Common Name: Calibrator Governing Regulation: 862.3200 Device Classification: Class II Classification Panel: Clinical Toxicology Code: DLJ
Legally marketed device to which equivalency is claimed:
AxSYM Gentamicin (K935376)
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Intended Use of Device:
The ARCHITECT iGentamicin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.
Description of Device:
The ARCHITECT iGentamicin assay is a one-step immunoassay for the quantitative determination of gentamicin in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex. In the ARCHITECT iGentamicin assay, sample, anti-gentamicin coated paramagnetic microparticles, and gentamicin acridinium-labeled conjugate are combined to create a reaction mixture. The anti-gentamicin coated microparticles bind to the gentamicin present in the sample and to the acridinium-labeled conjugate. After washing, pre-trigger and 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 gentamicin in the sample and the RLUs detected by the ARCHITECT i System optics.
Comparison of Technological Characteristics:
The ARCHITECT iGentamicin assay utilizes chemiluminescent microparticle immunoassay (CMIA) technology for the quantitative determination of gentamicin in human serum or plasma. The AxSYM Gentamicin assay utilizes Fluorescence Polarization Immunoassay (FPIA) technology for the quantitative measurement of gentamicin in serum or plasma.
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Summary of Analytical Performance:
The ARCHITECT iGentamicin assay is substantially equivalent to the AxSYM Gentamicin assay in terms of analytical performance data in this 510(k) submission.
The analytical performance of the ARCHITECT iGentamicin assay was demonstrated through the following studies, which are provided in this 510(k) submission:
- . Precision
- Limit of Blank, Limit of Detection, and Limit of Quantitation (Sensitivity) .
- . Linearity
- Interferences �
- Recovery .
- Manual Dilution .
- Matrix Comparison (Tube Type) ●
- Method Comparison (Correlation) .
3
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Abbott Laboratories c/o Judith Wallach, RAC Sr. Regulatory Administrator ADD Regulatory Affairs Dept 09V6, Bldg. AP6C-2 Abbott Park. IL 60064-6095
Re: K102699 Trade Name: ARCHITECT iGentamicin, ARCHITECT iGentamicin Calibrators (A-F) Regulation Number: 21 CFR 862.3450 Regulation Name: Gentamicin Test System Regulatory Class: Class II APR - 1 201 Product Codes: DLJ, LCD Dated: February 16, 2011 Received: February 17, 2011
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 (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
G.C.
Courtney Harper, Ph.D. 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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Admin 5.0 Indications for Use
510(k) Number (if known):
Device Name: ARCHITECT iGentamicin
Indications for Use:
Reagents:
The ARCHITECT iGentamicin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.
Calibrators:
The ARCHITECT iGentamicin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of gentamicin, an antibiotic drug, 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 Devices (OIVD)
an
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102699