Cleared Traditional

Elecsys AFP (K220176) - FDA 510(k) Clearance

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

K220176 · Roche Diagnostics · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
237d
Days
Class 2
Risk

K220176 is an FDA 510(k) clearance for the Elecsys AFP. Classified as Kit, Test,alpha-fetoprotein For Testicular Cancer (product code LOJ), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on September 15, 2022 after a review of 237 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 Roche Diagnostics devices

Submission Details

510(k) Number K220176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2022
Decision Date September 15, 2022
Days to Decision 237 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
133d slower than avg
Panel avg: 104d · This submission: 237d
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.

Regulatory Peers - LOJ Kit, Test,alpha-fetoprotein For Testicular Cancer

All 16
Devices cleared under the same product code (LOJ) and FDA review panel - the closest regulatory comparables to K220176.
VITROS AFP
K213626 · Ortho-Clinical Diagnostics · Jun 2022
VIDAS AFP ASSAY
K080017 · bioMerieux, Inc. · Sep 2008
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
K071597 · Dade Behring, Inc. · Jun 2008
IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2
K983263 · Diagnostic Products Corp. · Dec 1998
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
K981354 · Beckman Instruments, Inc. · May 1998
ELECSYS AFP
K973351 · Boehringer Mannheim Corp. · Nov 1997