Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-132: CLSI MM03-A2, Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline. (InVitro Diagnostics)
Date of Standard: 2006. |
| 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 DEVICE EVALUATION (ODE) | | |
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| (2) | OFFICE OF COMPLIANCE (OC) | | |
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| Devices Affected: |
| IVDs to Detect Infectious Diseases by Molecular Diagnostic Methodology |
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| Processes Affected: |
| Manufacturing/Devices Evaluation (510(k), PMA, PDP, IDE) |
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| Type of Standard: |
| Horizontal, National |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.3120 |
Dna Probe, Nucleic Acid Amplification, Chlamydia |
Class 1 |
MKZ |
| §866.3120 |
Dna-Reagents, Chlamydia |
Class 1 |
LSK |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.3370 |
Dna-Reagents, Mycobacterium Spp. |
Class 1 |
LQF |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.3390 |
Dna-Reagents, Neisseria |
Class 2 |
LSL |
| |
|
| Relevant Guidance: |
Review Criteria for Nucleic Acid Amplification Based In Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms
Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium species [tuberculosis]
Attachments to the Mycobacterium Guidance Document |
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| FDA Technical Contacts: |
| Kim Sapsford |
| FDA.CDRH/OSEL |
| 10903 New Hampshire Avenue WO Building 64, Rm 3022 |
| Silver Spring MD 20993 |
| 301/793-0311 |
| Email: kim.sapsford@fda.hhs.gov |
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