Cleared Traditional

K011140 - QUANTA PLEX ENA PROFILE 4

K011140 is the FDA 510(k) clearance for QUANTA PLEX ENA PROFILE 4 by Inova Diagnostics, Inc.. It is a Class 2 Immunology device (product code LLL) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K011140 · Inova Diagnostics, Inc. · Immunology device
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Jul 2001
Decision
105d
Days
Class 2
Risk

K011140 is an FDA 510(k) clearance for the QUANTA PLEX ENA PROFILE 4. 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 July 27, 2001 after a review of 105 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Inova Diagnostics, Inc. devices

Submission Details

510(k) Number K011140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2001
Decision Date July 27, 2001
Days to Decision 105 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
1d slower than avg
Panel avg: 104d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 116
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K011140.
QUANTA PLEX SLE PROFILE 8
K040160 · Inova Diagnostics, Inc. · Mar 2004
QUANTA PLEX ENA PROFILE 6
K031450 · Inova Diagnostics, Inc. · Jun 2003
QUANTA PLEX ENA PROFILE 5
K030681 · Inova Diagnostics, Inc. · Apr 2003
ENA EIA KIT RANGE
K010146 · The Binding Site, Ltd. · Mar 2001
ENA EIA KIT
K010147 · The Binding Site, Ltd. · Mar 2001
ENA SCREEN EIA KIT
K010148 · The Binding Site, Ltd. · Feb 2001