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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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.
QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls
K152013 · Inova Diagnostics, Inc. · Apr 2016
MODIFICATION TO AESKULISA DS DNA G
K081251 · Aesku Diagnostics · May 2008
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
K072393 · Phadia US, Inc. · Dec 2007
AESKULISA DS DNA G
K041628 · Aesku Diagnostics · Oct 2004
ANTI-DSDNA ANTIBODY TEST
K921658 · Immco Diagnostics, Inc. · Mar 1993
K060380 · FIDIS DSDNA
Download PDF FDA Summary Biomedical Diagnostic…