Cleared Traditional

K040160 - QUANTA PLEX SLE PROFILE 8

K040160 is an FDA 510(k) clearance for QUANTA PLEX SLE PROFILE 8, 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 45-day FDA review.

K040160 · Inova Diagnostics, Inc. · Immunology device
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Mar 2004
Decision
45d
Days
Class 2
Risk

K040160 is an FDA 510(k) clearance for the QUANTA PLEX SLE PROFILE 8. 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 March 8, 2004 after a review of 45 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 - K040160

510(k) Number K040160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2004
Decision Date March 08, 2004
Days to Decision 45 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
60d faster than avg
Panel avg: 105d · This submission: 45d
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 K040160.
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K041753 · Aesku Diagnostics · Jul 2004
QUANTA PLEX ENA PROFILE 6
K031450 · Inova Diagnostics, Inc. · Jun 2003
QUANTA PLEX ENA PROFILE 5
K030681 · Inova Diagnostics, Inc. · Apr 2003
QUANTA PLEX ENA PROFILE 4
K011140 · Inova Diagnostics, Inc. · Jul 2001