LifeScale Gram Negative Kit (LSGN) with LifeScale AST System
by Affinity Biosensors 3 variants
510(k) K211815
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK211815 | Date2 Apr 2024 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System
- 510(k) Number
- FDA Product Code
- SAN
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.1650
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System is an Automated Antimicrobial Susceptibility Test System for Positive Blood Culture Samples, designed for microbiological analysis. It identifies antimicrobial resistance patterns in Gram-negative bacteria, enabling rapid and accurate phenotypic testing to guide infection treatment. The system leverages population-profiling technology to assess bacterial susceptibility to antibiotics, supporting clinical decision-making in microbiology laboratories.
This kit is intended for use in clinical microbiology settings, where it is paired with the LifeScale AST System for automated processing. Supplied as a single-use consumable, it requires no additional sterilisation and is compatible with standard laboratory workflows. The device operates under FDA-cleared regulatory status (510(k) K211815) and adheres to Class II medical device classification. Storage and handling follow manufacturer guidelines to maintain test integrity, with no MRI safety considerations specified.
Other devices from Affinity Biosensors
Questions
AI-generated answers, 1 Oct 2026
What is the LifeScale Gram Negative Kit used for?
The LifeScale Gram Negative Kit is designed for automated antimicrobial susceptibility testing (AST) of Gram-negative bacteria isolated from positive blood culture samples. It helps microbiology laboratories quickly determine which antibiotics will effectively treat infections caused by these bacteria, supporting faster and more precise clinical decision-making.
How is the LifeScale Gram Negative Kit supplied and prepared for use?
The kit is supplied as a single-use consumable, meaning each test requires a new kit. No additional sterilization is needed before use, as it is pre-sterilized and ready for immediate application in standard laboratory workflows. It is intended to be paired exclusively with the LifeScale AST System for automated processing.
Is the LifeScale Gram Negative Kit reusable or single-use?
The kit is explicitly designed for single-use only. This ensures consistency, reduces contamination risks, and maintains the accuracy of antimicrobial susceptibility results. Each kit is pre-sterilized and intended for one use per test cycle.
What regulatory approval does the LifeScale Gram Negative Kit hold?
The kit holds FDA 510(k) clearance under the reference number K211815, classified as a Class II medical device. This clearance confirms its substantial equivalence to a predicate device and compliance with U.S. regulatory standards for antimicrobial susceptibility testing systems.
How should the LifeScale Gram Negative Kit be stored?
Storage and handling instructions are provided by the manufacturer to preserve test integrity. While specific conditions (e.g., temperature, humidity) are not detailed in the data, standard laboratory practices for consumable medical devices should be followed. Ensure the kit remains in its original packaging until use to prevent contamination or degradation.