Cleared Traditional

K980312 - NOVA LITE ENDOMYSIAL

K980312 is an FDA 510(k) clearance for NOVA LITE ENDOMYSIAL, manufactured by Inova Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DBL cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K980312 · Inova Diagnostics, Inc. · Immunology device
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Apr 1998
Decision
65d
Days
Class 2
Risk

K980312 is an FDA 510(k) clearance for the NOVA LITE ENDOMYSIAL. Classified as Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (product code DBL), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on April 2, 1998 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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 - K980312

510(k) Number K980312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1998
Decision Date April 02, 1998
Days to Decision 65 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
40d faster than avg
Panel avg: 105d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBL Device Classification - Class 2, Special Controls

Product Code DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 - DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

All 18
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