Cleared Traditional

K881341 - NOVA LITE(TM) SA

K881341 is the FDA 510(k) clearance for NOVA LITE(TM) SA by Inova Diagnostics, Inc.. It is a Class 2 Immunology device (product code LLL) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K881341 · Inova Diagnostics, Inc. · Immunology device
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Sep 1988
Decision
177d
Days
Class 2
Risk

K881341 is an FDA 510(k) clearance for the NOVA LITE(TM) SA. 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 September 22, 1988 after a review of 177 days - an extended review 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: 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 K881341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1988
Decision Date September 22, 1988
Days to Decision 177 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 104d · This submission: 177d
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 K881341.
NOVA GEL(TM) T JO-1
K896462 · Inova Diagnostics, Inc. · Nov 1989
ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST
K895339 · Immco Diagnostics, Inc. · Oct 1989
NOVA GEL(TM) JO-1
K892897 · Inova Diagnostics, Inc. · May 1989
NOVA LITE(TM) AUTOANTIBODY CONTROLS
K881340 · Inova Diagnostics, Inc. · Jun 1988
NOVA GEL (TM) SCL-70
K880897 · Inova Diagnostics, Inc. · Apr 1988
NOVA LITE(TM) ANA PLUS
K881339 · Inova Diagnostics, Inc. · Apr 1988