Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-229: CLSI M02-A11, Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard - Eleventh 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 |
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) | | DIVISION OF MICROBIOLOGY (DMD) |
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| (2) | OFFICE OF COMPLIANCE (OC) |
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| Devices Affected: |
| Antimicrobial Susceptibility Discs Regulated Under 21 CFR 866.1620 |
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| Processes Affected: |
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| Type of Standard: |
| Horizontal, National |
| Extent of Recognition: |
| Partial Recognition; all procedures and methods are recognized, interpretive criteria and QC parameters, when different from CDER approved drug labeling, are not recognized. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.1620 |
Discs, Elution |
Class 2 |
LTX |
| §866.1620 |
Susceptibility Test Discs, Antimicrobial |
Class 2 |
JTN |
| |
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| Relevant Guidance: |
| Review Criteria for Assessment of Antimicrobial Susceptibility Test Discs |
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| FDA Technical Contact: |
| Alexandra Wong |
| FDA/CDRH/OIVD |
| 10993 New Hampshire Avenue Building 66, Room 5502 |
| Silver Spring MD 20993 |
| 301/796-6210 |
| Email: alexandra.wong@fda.hhs.gov |
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