API 3600S Antimicrobial Susceptibility System

No FDA recalls on record, checked 22 Oct 2026.

Generic Name

SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

PMA Number

P800029 ↗

FDA Product Code

LON

Device Class

Class II

Regulation

21 CFR Part 866.1645

Advisory Committee

Microbiology

FDA Decision

APRL

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See all devices from Analytical Products, Inc. →

• What is the primary purpose of the API 3600S Antimicrobial Susceptibility System in a clinical microbiology lab?

  The API 3600S is designed to automate the identification and evaluation of bacterial resistance patterns to antimicrobial agents. It performs antimicrobial susceptibility testing with a short incubation period, helping labs quickly and consistently determine which antibiotics will effectively treat bacterial infections.

• Is the API 3600S itself single-use or reusable, and what about its consumables?

  The API 3600S device itself is reusable, but it requires disposable consumables for operation. These consumables are intended for single-use, ensuring each test run is performed with fresh materials.

• What regulatory pathway was followed for the approval of this device, and what does that mean for its use?

  The API 3600S was authorized through the FDA’s Premarket Approval (PMA) process under PMA number P800029. This means it underwent rigorous review by the FDA to ensure its safety and effectiveness for its intended use in antimicrobial susceptibility testing, adhering to the requirements outlined in 21 CFR 866.1645.

• Does the API 3600S require special handling or sterility measures beyond standard lab practices?

  The device does not require any specific sterility measures beyond those typically followed in a microbiology lab. It is designed for use under controlled laboratory conditions, where standard hygiene and contamination prevention protocols are already in place.

• How does the short-incubation feature of this system benefit clinical workflows?

  The short-incubation design allows for faster results compared to traditional methods, enabling labs to identify bacterial resistance patterns more quickly. This accelerates treatment decisions, reduces turnaround time for clinicians, and helps manage patient care more efficiently in busy microbiology environments.