Cleared Traditional

K202067 - EliA SmDP-S

K202067 is the FDA 510(k) clearance for EliA SmDP-S by Phadia AB. It is a Class 2 Immunology device (product code LKP) cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K202067 · Phadia AB · Immunology device
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Jul 2021
Decision
352d
Days
Class 2
Risk

K202067 is an FDA 510(k) clearance for the EliA SmDP-S. 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 July 14, 2021 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Phadia AB devices

Submission Details

510(k) Number K202067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2020
Decision Date July 14, 2021
Days to Decision 352 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
248d slower than avg
Panel avg: 104d · This submission: 352d
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 K202067.
EliA SmDP Immunoassay
K183007 · Phadia AB · Dec 2018
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