ARCHITECT iGentamicin

K243500 · Abbott Laboratories · LCD · Jul 9, 2025 · Clinical Toxicology

Device Facts

• Record ID: K243500
• Device Name: ARCHITECT iGentamicin
• Applicant: Abbott Laboratories
• Product Code: LCD · Clinical Toxicology
• Decision Date: Jul 9, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3450
• Device Class: Class 2

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 iSystem 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.

Device Story

ARCHITECT iGentamicin is an automated in vitro diagnostic assay for quantitative measurement of gentamicin in human serum or plasma. It utilizes Chemiflex CMIA technology on the ARCHITECT iSystem. Input: patient serum/plasma sample. Process: sample, anti-gentamicin coated paramagnetic microparticles, and acridinium-labeled gentamicin conjugate form a reaction mixture; microparticles bind gentamicin and conjugate; after washing, Pre-Trigger and Trigger solutions are added to initiate chemiluminescence. Output: relative light units (RLUs) measured by system optics, which are inversely proportional to gentamicin concentration. Used in clinical laboratories by technicians; results assist clinicians in therapeutic drug monitoring and overdose management to optimize patient antibiotic therapy.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation of reagent modifications demonstrating performance consistency with the predicate device.

Technological Characteristics

Chemiluminescent microparticle immunoassay (CMIA). Reagent-based diagnostic assay. Designed for use on the ARCHITECT i2000SR automated analyzer platform. Fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for the quantitative determination of gentamicin in human serum or plasma to aid in the diagnosis and treatment of gentamicin overdose and to monitor therapeutic levels.

Regulatory Classification

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.

Predicate Devices

• ARCHITECT iGentamicin (k102699)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K243500

B Applicant

Abbott Laboratories

C Proprietary and Established Names

ARCHITECT iGentamicin

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| LCD | Class II | 21 CFR 862.3450 - Gentamicin Test System | TX - Clinical Toxicology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

{1}

demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for reagent changes to ARCHITECT iGentamicin assay (k102699) on the ARCHITECT i2000SR System.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

K243500 - Page 2 of 2