Cleared Traditional

K220085 - KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit (FDA 510(k) Clearance)

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

K220085 · Kronus, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
590d
Days
Class 2
Risk

K220085 is an FDA 510(k) clearance for the KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit. Classified as Tyrosine Phosphatase (ia-2) Autoantibody Assay (product code OIF), Class II - Special Controls.

Submitted by Kronus, Inc. (Star, US). The FDA issued a Cleared decision on August 24, 2023 after a review of 590 days - an unusually long review period, suggesting complex equivalence evaluation.

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

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Kronus, Inc. devices

Submission Details

510(k) Number K220085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2022
Decision Date August 24, 2023
Days to Decision 590 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
502d slower than avg
Panel avg: 88d · This submission: 590d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OIF Tyrosine Phosphatase (ia-2) Autoantibody Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
Definition The Device Is Used For The Semi-quantitative Determination Of Autoantibodies Against Tyrosine Phosphatase (ia-2) In Human Serum As An Aid In The Diagnosis Of Type 1 Diabetes Mellitus (autoimmune Mediated Diabetes).
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 Chemistry devices follow this clearance model.