Cleared Traditional

K183007 - EliA SmDP Immunoassay

K183007 is the FDA 510(k) clearance for EliA SmDP Immunoassay by Phadia AB. It is a Class 2 Immunology device (product code LKP) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K183007 · Phadia AB · Immunology device
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Dec 2018
Decision
54d
Days
Class 2
Risk

K183007 is an FDA 510(k) clearance for the EliA SmDP Immunoassay. Classified as Anti-sm Antibody, Antigen And Control (product code LKP), Class II - Special Controls.

Submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on December 24, 2018 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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 K183007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2018
Decision Date December 24, 2018
Days to Decision 54 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
50d faster than avg
Panel avg: 104d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKP Anti-sm Antibody, Antigen And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 Consultant

Phadia US, Inc.
Sheryl Skinner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LKP Anti-sm Antibody, Antigen And Control

All 8
Devices cleared under the same product code (LKP) and FDA review panel - the closest regulatory comparables to K183007.
EliA SmDP-S
K202067 · Phadia AB · Jul 2021
QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,
K123593 · Inova Diagnostics, Inc. · Apr 2013
LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115
K024219 · Bio-Rad · Jan 2003
LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208
K984479 · Bio-Rad · Dec 1998
THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO
K983420 · Zeus Scientific, Inc. · Nov 1998
HYTEC AUTOIMMUNE KITS (SM)
K954896 · Hycor Biomedical, Inc. · Mar 1996