Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-228: CLSI M11-A8, Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition. (InVitro Diagnostics)
Date of Standard: 2012. |
| Address of Standards Organization: |
| Clinical Laboratory Standards Institute (CLSI) |
| 950 West Valley Road |
| Suite 2500 |
| Wayne, PA 19087 |
| |
|
| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) | | DIVISION OF MICROBIOLOGY (DMD) |
|
|
| Devices Affected: |
| Antimicrobial Susceptibility Systems Regulated Under 21 CFR 66.1640 and 866.1645 |
|
| Processes Affected: |
|
| Type of Standard: |
| National, Horizontal |
| Extent of Recognition: |
| Partial Recognition; All procedures and methods are recognized, interpretive criteria when different from CDER approved drug labeling not recognized. |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.1640 |
Manual Antimicrobial Susceptibility Test Systems |
Class 2 |
JWY |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.1645 |
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
Class 2 |
LON |
| |
|
| Relevant Guidance: |
| Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA |
|
| FDA Technical Contact: |
| Ribhi Shawar, Ph.D. |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room 5513 |
| Silver Spring MD 20993 |
| 301/796-6698 |
| Email: ribhi.shawar@fda.hhs.gov |
|
|
