Cleared Traditional

K171731 - KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

K171731 is an FDA 510(k) clearance for KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit, manufactured by Kronus, Inc.. The device is a Class 2 Chemistry device with product code OIF cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K171731 · Kronus, Inc. · Chemistry device
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Jan 2018
Decision
221d
Days
Class 2
Risk

K171731 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 January 19, 2018 after a review of 221 days - an extended review cycle.

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

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FDA 510(k) Submission Details - K171731

510(k) Number K171731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2017
Decision Date January 19, 2018
Days to Decision 221 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 88d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OIF Device Classification - Class 2, Special Controls

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.