Cleared Traditional

K883232 - HISTONE REACTIVE ANA

K883232 is the FDA 510(k) clearance for HISTONE REACTIVE ANA by Val Tech Diagnostics, Inc.. It is a Class 2 Immunology device (product code LLL) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K883232 · Val Tech Diagnostics, Inc. · Immunology device
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Sep 1988
Decision
37d
Days
Class 2
Risk

K883232 is an FDA 510(k) clearance for the HISTONE REACTIVE ANA. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Val Tech Diagnostics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on September 7, 1988 after a review of 37 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 Val Tech Diagnostics, Inc. devices

Submission Details

510(k) Number K883232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1988
Decision Date September 07, 1988
Days to Decision 37 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 104d · This submission: 37d
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 118
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K883232.
ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST
K895339 · Immco Diagnostics, Inc. · Oct 1989
NOVA GEL(TM) JO-1
K892897 · Inova Diagnostics, Inc. · May 1989
NOVA LITE(TM) SA
K881341 · Inova Diagnostics, Inc. · Sep 1988
NOVA LITE(TM) AUTOANTIBODY CONTROLS
K881340 · Inova Diagnostics, Inc. · Jun 1988
NOVA GEL (TM) SCL-70
K880897 · Inova Diagnostics, Inc. · Apr 1988
NOVA LITE(TM) ANA PLUS
K881339 · Inova Diagnostics, Inc. · Apr 1988