Cleared Traditional

K883883 - ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 ...

K883883 is an FDA 510(k) clearance for ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 ..., manufactured by Immco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LKJ cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K883883 · Immco Diagnostics, Inc. · Immunology device
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Oct 1988
Decision
44d
Days
Class 2
Risk

K883883 is an FDA 510(k) clearance for the ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS). Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on October 27, 1988 after a review of 44 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 - K883883

510(k) Number K883883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1988
Decision Date October 27, 1988
Days to Decision 44 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 104d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKJ Device Classification - Class 2, Special Controls

Product Code LKJ Antinuclear Antibody, 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 - LKJ Antinuclear Antibody, Antigen, Control

All 35
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K883883.
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SERATEST ENA [SCL-70] KIT
K894411 · Hemagen Diagnostics, Inc. · Aug 1989
ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT)
K883949 · Immco Diagnostics, Inc. · Oct 1988
NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)
K874115 · Sigma Diagnostics, Inc. · Nov 1987
KALLESTAD SM/RNP TEST REAGENT
K862313 · Kallestad Laboratories, Inc. · Aug 1986