Cleared Traditional

K213626 - VITROS AFP (FDA 510(k) Clearance)

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

K213626 · Ortho-Clinical Diagnostics · Immunology device
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Jun 2022
Decision
210d
Days
Class 2
Risk

K213626 is an FDA 510(k) clearance for the VITROS AFP. Classified as Kit, Test,alpha-fetoprotein For Testicular Cancer (product code LOJ), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics (Pencoed, GB). The FDA issued a Cleared decision on June 15, 2022 after a review of 210 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - 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.

View all Ortho-Clinical Diagnostics devices

Submission Details

510(k) Number K213626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2021
Decision Date June 15, 2022
Days to Decision 210 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 104d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LOJ Kit, Test,alpha-fetoprotein For Testicular Cancer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
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.