Cleared Traditional

EliA PR3s Immunoassay (K173792) - FDA 510(k) Clearance

Also marketed or referenced as:
EliA MPOs Immunoassay EliA GBM Immunoassay

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

K173792 · Phadia AB · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
89d
Days
Class 2
Risk

K173792 is an FDA 510(k) clearance for the EliA PR3s Immunoassay. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on March 13, 2018 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Phadia AB devices

Submission Details

510(k) Number K173792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2017
Decision Date March 13, 2018
Days to Decision 89 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
15d faster than avg
Panel avg: 104d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 - MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)

All 22
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