Cleared Traditional

K922833 - QUANTA LITE RNP ELISA

K922833 is the FDA 510(k) clearance for QUANTA LITE RNP ELISA by Inova Diagnostics, Inc.. It is a Class 2 Immunology device (product code LLL) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K922833 · Inova Diagnostics, Inc. · Immunology device
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Sep 1992
Decision
98d
Days
Class 2
Risk

K922833 is an FDA 510(k) clearance for the QUANTA LITE RNP ELISA. 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 18, 1992 after a review of 98 days - within the typical 510(k) review window.

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 K922833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1992
Decision Date September 18, 1992
Days to Decision 98 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
6d faster than avg
Panel avg: 104d · This submission: 98d
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 K922833.
QUANTA LITE SS-A ELISA
K922830 · Inova Diagnostics, Inc. · Sep 1992
QUANTA LITE SM ELISA
K922831 · Inova Diagnostics, Inc. · Sep 1992
QUANTA LITE SS-B ELISA
K922832 · Inova Diagnostics, Inc. · Sep 1992
HEMAGEN ENA [JO-1] KIT (EIA METHOD)
K915420 · Hemagen Diagnostics, Inc. · Apr 1992
ANTI-ENA ANTIBODY TEST [SS-A (RO)]
K920383 · Immco Diagnostics, Inc. · Mar 1992
ANIT-ENA ANTIBODY TEST [SS-B (LA)]
K920384 · Immco Diagnostics, Inc. · Mar 1992