Cleared Traditional

K983084 - QUANTA LITE RF IGA ELISA

K983084 is the FDA 510(k) clearance for QUANTA LITE RF IGA ELISA by Inova Diagnostics, Inc.. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K983084 · Inova Diagnostics, Inc. · Immunology device
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Nov 1998
Decision
62d
Days
Class 2
Risk

K983084 is an FDA 510(k) clearance for the QUANTA LITE RF IGA ELISA. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on November 4, 1998 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5775 - 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

Submission Details

510(k) Number K983084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1998
Decision Date November 04, 1998
Days to Decision 62 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
42d faster than avg
Panel avg: 104d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHR System, Test, Rheumatoid Factor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5775
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 - DHR System, Test, Rheumatoid Factor

All 82
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K983084.
RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS
K984045 · Kamiya Biomedical Co. · Jan 1999
THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL
K983418 · Zeus Scientific, Inc. · Nov 1998
QUANTA LITE RF IGG ELISA
K983083 · Inova Diagnostics, Inc. · Nov 1998
DIAMEDIX IS-RF TEST SYSTEM
K974889 · Diamedix Corp. · Mar 1998
RAPET RF
K974370 · Stanbio Laboratory · Feb 1998
QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
K973464 · Instrumentation Laboratory CO · Oct 1997