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.

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.

AI/ML Overview

The provided text describes a 510(k) submission for the ARCHITECT iGentamicin assay and its calibrators. It outlines the intended use, device description, and a summary of analytical performance studies conducted to demonstrate substantial equivalence to a legally marketed predicate device (AxSYM Gentamicin). However, it does not contain specific acceptance criteria values or detailed results of the studies in a manner that would allow for the construction of the requested table and comprehensive answers to all questions.

Here's an attempt to answer based on the available information, with significant limitations due to the missing data:

Acceptance Criteria and Device Performance

The document states that the ARCHITECT iGentamicin assay is "substantially equivalent to the AxSYM Gentamicin assay in terms of analytical performance data in this 510(k) submission." This implies that the acceptance criteria for each validation study would have been defined to demonstrate this equivalence, likely by showing that the performance of the new device is within predefined statistical limits compared to the predicate. However, the specific numerical acceptance criteria and the reported device performance values are not detailed in the provided text.

Therefore, a table of acceptance criteria and reported device performance cannot be fully constructed from the given text. The text only lists the types of studies performed (e.g., Precision, Linearity, Method Comparison).

Study Details Based on Available Information:

A table of acceptance criteria and the reported device performance:
- Cannot be fully constructed as the specific numerical acceptance criteria and reported performance values are not provided in the input text. The text only lists the types of studies performed without their results or target specifications.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not specified in the provided text. The document lists "Method Comparison (Correlation)" as one of the studies, which would typically involve a test set of patient samples. However, details on sample size, origin, or retrospective/prospective nature are absent.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable/Not specified. This device is an in vitro diagnostic (IVD) assay for quantitative determination of gentamicin. Ground truth for such assays is typically established through a reference method or validated analytical techniques, not by expert consensus (e.g., radiologists interpreting images). The text does not mention expert involvement in establishing ground truth for the analytical performance studies.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Adjudication methods are typically used in clinical studies where subjective interpretation (e.g., image reading) is involved. For an IVD assay's analytical performance, the "ground truth" (or reference values) for samples are typically determined by highly accurate and precise analytical methods, not through an adjudication process involving multiple human experts.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This submission is for an in vitro diagnostic (IVD) reagent kit and calibrator, not an AI-assisted diagnostic imaging or interpretation device. Therefore, an MRMC study or assessment of human reader improvement with AI is not relevant to this submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The ARCHITECT iGentamicin assay, as an automated chemiluminescent microparticle immunoassay (CMIA), operates as a standalone analytical system to produce quantitative results. Its "performance" refers to the accuracy, precision, linearity, and other analytical characteristics of the assay itself, independent of human interpretation or assistance beyond operating the instrument and processing samples. The "Summary of Analytical Performance" directly addresses its standalone performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "Method Comparison (Correlation)" study, the "ground truth" would be the results obtained from the legally marketed predicate device, AxSYM Gentamicin assay, or a recognized reference method. The study would aim to demonstrate correlation and agreement between the new device's results and this established reference. For other analytical studies (Precision, Linearity), the "ground truth" is derived from known concentrations of analytes in control materials or reference standards.
The sample size for the training set:
- Not specified. As an IVD assay based on established chemical and immunological principles, it's unlikely that the "training set" in the sense of machine learning applies directly here. If "training" refers to method development and optimization, the sample sizes used for such internal studies are not detailed in this summary.
How the ground truth for the training set was established:
- Not applicable in the context of machine learning training. If "training set" refers to samples used during assay development and optimization, the "ground truth" for these samples would typically be established using highly accurate and precise analytical methods, often a reference method or gravimetrically prepared standards with known concentrations. The specific details are not provided in this regulatory summary.

Summary

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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:

Description of Device:

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) .

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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:

Calibrators:

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)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102699

Regulation Number and Section

§ 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.