Cleared Traditional

K880896 - NOVA GEL(TM) SS-A/SS-B

K880896 is an FDA 510(k) clearance for NOVA GEL(TM) SS-A/SS-B, 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 23-day FDA review.

K880896 · Inova Diagnostics, Inc. · Immunology device
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Mar 1988
Decision
23d
Days
Class 2
Risk

K880896 is an FDA 510(k) clearance for the NOVA GEL(TM) SS-A/SS-B. 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 25, 1988 after a review of 23 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 - K880896

510(k) Number K880896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1988
Decision Date March 25, 1988
Days to Decision 23 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
82d faster than avg
Panel avg: 105d · This submission: 23d
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 K880896.
NOVA LITE(TM) ANA PLUS
K881339 · Inova Diagnostics, Inc. · Apr 1988
NOVA GEL(TM) SM/RNP
K881181 · Inova Diagnostics, Inc. · Apr 1988
NOVA LITE(TM) ANA
K880736 · Inova Diagnostics, Inc. · Mar 1988
FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES
K873708 · Whittaker Bioproducts, Inc. · Nov 1987
ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS)
K871994 · Behring Diagnostics, Inc. · Aug 1987
SERATEST ENA [SS-B] KIT
K862700 · Hemagen Diagnostics, Inc. · Aug 1986