Cleared Traditional

K031450 - QUANTA PLEX ENA PROFILE 6

K031450 is an FDA 510(k) clearance for QUANTA PLEX ENA PROFILE 6, manufactured by Inova Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K031450 · Inova Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
49d
Days
Class 2
Risk

K031450 is an FDA 510(k) clearance for the QUANTA PLEX ENA PROFILE 6. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on June 25, 2003 after a review of 49 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 Inova Diagnostics, Inc. devices

FDA 510(k) Submission Details - K031450

510(k) Number K031450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2003
Decision Date June 25, 2003
Days to Decision 49 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 105d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

Product Code LLL Extractable Antinuclear 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 - LLL Extractable Antinuclear Antibody, Antigen And Control

All 146
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K031450.
ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400
K043067 · Bioarray Solutions, Ltd. · May 2005
AESKULISA ENA 6 S
K041753 · Aesku Diagnostics · Jul 2004
QUANTA PLEX SLE PROFILE 8
K040160 · Inova Diagnostics, Inc. · Mar 2004
QUANTA PLEX ENA PROFILE 5
K030681 · Inova Diagnostics, Inc. · Apr 2003
QUANTA PLEX ENA PROFILE 4
K011140 · Inova Diagnostics, Inc. · Jul 2001
ENA EIA KIT RANGE
K010146 · The Binding Site, Ltd. · Mar 2001