Cleared Traditional

K920383 - ANTI-ENA ANTIBODY TEST [SS-A (RO)]

K920383 is an FDA 510(k) clearance for ANTI-ENA ANTIBODY TEST [SS-A (RO)], manufactured by Immco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K920383 · Immco Diagnostics, Inc. · Immunology device
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Mar 1992
Decision
60d
Days
Class 2
Risk

K920383 is an FDA 510(k) clearance for the ANTI-ENA ANTIBODY TEST [SS-A (RO)]. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on March 30, 1992 after a review of 60 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 Immco Diagnostics, Inc. devices

FDA 510(k) Submission Details - K920383

510(k) Number K920383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1992
Decision Date March 30, 1992
Days to Decision 60 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
44d faster than avg
Panel avg: 104d · This submission: 60d
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 135
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K920383.
QUANTA LITE SS-B ELISA
K922832 · Inova Diagnostics, Inc. · Sep 1992
QUANTA LITE RNP ELISA
K922833 · Inova Diagnostics, Inc. · Sep 1992
HEMAGEN ENA [JO-1] KIT (EIA METHOD)
K915420 · Hemagen Diagnostics, Inc. · Apr 1992
ANIT-ENA ANTIBODY TEST [SS-B (LA)]
K920384 · Immco Diagnostics, Inc. · Mar 1992
ANTI-ENA ANTIBODY TEST (SM)
K920385 · Immco Diagnostics, Inc. · Mar 1992
ANTI-ENA ANTIBODY TEST KIT
K920386 · Immco Diagnostics, Inc. · Mar 1992