Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-136: CLSI I/LA2-A2, Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Flurescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline - Second Edition. (InVitro Diagnostics)
Date of Standard: 2006. |
| 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 IMMUNOLOGY AND HEMATOLOGY DEVICES (DIHD) |
|
|
| Devices Affected: |
| Devices to test for autoantibodies to nuclear antigen (ANA) |
|
| Processes Affected: |
| 510(K), PMA, PDP, IDE, HDE |
|
| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §866.5100 |
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls |
Class 2 |
LJM |
| §866.5100 |
Antinuclear Antibody, Antigen, Control |
Class 2 |
LKJ |
| §866.5100 |
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
Class 2 |
DHN |
| §866.5100 |
Extractable Antinuclear Antibody, Antigen And Control |
Class 2 |
LLL |
| |
|
| Relevant Guidance: |
| Review Criteria for the the Assessment of Anti-Nuclear Antiboy Test Systems; Guidance for Industry and FDA |
|
| FDA Technical Contact: |
|
