Cleared Traditional

K121046 - STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K121046 · Kronus Market Development Associates, Inc. · Immunology device
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Dec 2012
Decision
258d
Days
Class 2
Risk

K121046 is an FDA 510(k) clearance for the STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT. Classified as 21-hydroxylase Antibody (21-ohab) (product code PCG), Class II - Special Controls.

Submitted by Kronus Market Development Associates, Inc. (Star, US). The FDA issued a Cleared decision on December 20, 2012 after a review of 258 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K121046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2012
Decision Date December 20, 2012
Days to Decision 258 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 104d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PCG 21-hydroxylase Antibody (21-ohab)
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.