Recognition List Number: 009 Publication Date: 03/08/2004
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 7-88: NCCLS C37-A, Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline. (InVitro Diagnostics)
Date of Standard: 1999. |
| Address of Standards Organization: |
| National Committee for Clinical Laboratory Standards (NCCLS) |
| 950 West Valley Road |
| Suite 2500 |
| Wayne, PA 19087 |
| |
|
| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) | | DIVISION OF CHEMISTRY AND TOXICOLOGY DEVICES (DCTD) |
|
| (2) | OFFICE OF COMPLIANCE (OC) |
|
|
| Devices Affected: |
| In Vitro Diagnostic devices for the measurement of total cholesterol, HDL cholesterol and LDL cholesterol in vitro diagnostic calibrator materials |
|
| Processes Affected: |
|
| Extent of Recognition: |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §862.1150 |
Calibrator, Multi-Analyte Mixture |
Class 2 |
JIX |
| §862.1150 |
Calibrator, Secondary |
Class 2 |
JIT |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §862.1175 |
Acid, Ferric Ion-Sulfuric, Cholesterol |
Class 1 |
CHD |
| §862.1175 |
Enzymatic Esterase--Oxidase, Cholesterol |
Class 1 |
CHH |
| §862.1175 |
Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol |
Class 1 |
CGO |
| §862.1175 |
Lipoprotein, High Density, Hdl, Over The Counter |
Class 1 |
NAQ |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §862.1475 |
Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl |
Class 1 |
LBT |
| §862.1475 |
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl |
Class 1 |
LBS |
| §862.1475 |
Ldl & Vldl Precipitation, Hdl |
Class 1 |
LBR |
| §862.1475 |
System, Test, Low Density, Lipoprotein |
Class 1 |
MRR |
| |
|
| Relevant Guidance: |
| Guidance for 510(K)s on Cholesterol Tests for Clinical Laboratory, Physician's Office Laboratory, and Home Use Guidance for Industry - Abbreviated 510(K) Submissions for In Vitro Diagnostic Calibrators Points to Consider for Collection of Data in Support of In Vitro Device Submissions for 510(K) Clearance. |
|
| FDA Technical Contact: |
| Carol C. Benson |
| FDA/CDRH/OIVD |
| 2098 GAITHER ROAD, HFZ-440 |
| ROCKVILLE MD 20850 |
| 240/276-0396 |
| Email: carol.benson@fda.hhs.gov |
|
|
|
|
