K180607 is an FDA 510(k) clearance for the Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit. This device is classified as a 21-hydroxylase Antibody (21-ohab) (Class II - Special Controls, product code PCG).
Submitted by Kronus, Inc. (Star, US). The FDA issued a Cleared decision on November 23, 2018, 261 days after receiving the submission on March 7, 2018.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660. For Semi-quantitative Determination Of Antibodies To Steroid 21-hydroxylase (21-oh) In Human Serum. The Assay May Be Useful As An Aid In The Diagnosis Of Autoimmune Adrenal Disease, Whether Expressed As Autoimmune Addison's Disease (isolated) Or Addison's Disease As Part Of More Complex Autoimmune Polyglandular Syndrome (aps), Type I Or Ii. The Assay Result Is To Be Used In Conjunction With Other Clinical And Laboratory Findings And Is Not A Substitute For Functional Testing Required To Diagnose Adrenal Insufficiency..
| 510(k) Number | K180607 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2018 |
| Decision Date | November 23, 2018 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | PCG - 21-hydroxylase Antibody (21-ohab) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |
| Definition | For Semi-quantitative Determination Of Antibodies To Steroid 21-hydroxylase (21-oh) In Human Serum. The Assay May Be Useful As An Aid In The Diagnosis Of Autoimmune Adrenal Disease, Whether Expressed As Autoimmune Addison's Disease (isolated) Or Addison's Disease As Part Of More Complex Autoimmune Polyglandular Syndrome (aps), Type I Or Ii. The Assay Result Is To Be Used In Conjunction With Other Clinical And Laboratory Findings And Is Not A Substitute For Functional Testing Required To Diagnose Adrenal Insufficiency. |