Cleared Traditional

K060380 - FIDIS DSDNA

K060380 is an FDA 510(k) clearance for FIDIS DSDNA, manufactured by Biomedical Diagnostics (Bmd) SA. The device is a Class 2 Immunology device with product code LSW cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K060380 · Biomedical Diagnostics (Bmd) SA · Immunology device
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May 2006
Decision
77d
Days
Class 2
Risk

K060380 is an FDA 510(k) clearance for the FIDIS DSDNA. Classified as Anti-dna Antibody, Antigen And Control (product code LSW), Class II - Special Controls.

Submitted by Biomedical Diagnostics (Bmd) SA (Marne La Vallee Cedex 2, FR). The FDA issued a Cleared decision on May 2, 2006 after a review of 77 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 Biomedical Diagnostics (Bmd) SA devices

FDA 510(k) Submission Details - K060380

510(k) Number K060380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2006
Decision Date May 02, 2006
Days to Decision 77 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
28d faster than avg
Panel avg: 105d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LSW Device Classification - Class 2, Special Controls

Product Code LSW Anti-dna 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 Peers - LSW Anti-dna Antibody, Antigen And Control

Devices cleared under the same product code (LSW) and FDA review panel - the closest regulatory comparables to K060380.
AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10
K172348 · Aesku.Diagnostics GmbH & Co. KG · Feb 2018
QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls
K152013 · Inova Diagnostics, Inc. · Apr 2016
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
K072393 · Phadia US, Inc. · Dec 2007
ANTI-DSDNA ANTIBODY TEST
K921658 · Immco Diagnostics, Inc. · Mar 1993