Cleared Traditional

K901596 - NOVA LITE(TM) ANA KSL

K901596 is an FDA 510(k) clearance for NOVA LITE(TM) ANA KSL, manufactured by Inova Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K901596 · Inova Diagnostics, Inc. · Immunology device
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May 1990
Decision
27d
Days
Class 2
Risk

K901596 is an FDA 510(k) clearance for the NOVA LITE(TM) ANA KSL. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on May 2, 1990 after a review of 27 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 - K901596

510(k) Number K901596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1990
Decision Date May 02, 1990
Days to Decision 27 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
78d faster than avg
Panel avg: 105d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHN Device Classification - Class 2, Special Controls

Product Code DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, 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 - DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

All 70
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K901596.
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
K944096 · Immuno Concepts, Inc. · Nov 1994
DIASTAT ANTI-JO-1 KIT
K912292 · Shield Diagnostics, Ltd. · Jul 1991
HEMAGEN ENA [JO-I] KIT
K902139 · Hemagen Diagnostics, Inc. · May 1990
NOVA LITE(TM) ANA MK
K901595 · Inova Diagnostics, Inc. · Apr 1990
ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM
K897025 · Zeus Scientific, Inc. · Jan 1990
ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)
K884400 · Immco Diagnostics, Inc. · Nov 1988