# K991473: Sirscan

- Pathway: 510(k) (Traditional)
- Applicant: Intelligence Artificielle Applications
- Decided: Nov 23, 1999 after 210 days
- Product code: KZK (Reader, Zone, Automated)
- Device class: 1
- Regulation: 21 CFR 866.2850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The SIRSCAN automated zone reader device is a video-camera image analysis computer-based system to read susceptibility test data from NCCLS M2-A6 Kirby-Bauer disk-diffusion test plates for the following organisms: enterobacteriacae; staphylococci, (except coagulase negative staphylococci with weak growth); and non-fermenting gram negative bacilli (except strains with weak growth). Other susceptibility tests on solid medium are read with the electronic caliper, and the resuilts of susceptibility tests in other media can be keyed in manually. The SIRSCAN data management system compiles data from the NCCLS agar disk diffusion test. It prints, files and produces integrated resuits reports, regularly or on request, to be used by clinicians, bacteriologists and epidemiologists. Its expert system feature offers consistency checks for validation of tests and results. In addition, the SIRSCAN data management system: interprets zones; calculates MICs; provides quality control and epidemiology and infection control; identifies and eliminates duplicates; compares patient histories; classifies and monitors resistance phenotypes; monitors multi-resistant organisms; detects and monitors nosocomial infections; and prepares epidemiological statistics. SIRSCAN can be connected to any laboratory management system, as well as to some micro-dilution systems (e.g., Vitek™, Microscan™).

Source page: https://510kreport.com/device/K991473
Methodology: https://510kreport.com/methodology