Cleared Traditional

QUALITROL ANA CONTROL SERUM SET (K961815) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961815 · Consolidated Technologies, Inc. · Immunology device
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Sep 1996
Decision
140d
Days
Class 2
Risk

K961815 is an FDA 510(k) clearance for the QUALITROL ANA CONTROL SERUM SET. Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), Class II - Special Controls.

Submitted by Consolidated Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on September 27, 1996 after a review of 140 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 Consolidated Technologies, Inc. devices

Submission Details

510(k) Number K961815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1996
Decision Date September 27, 1996
Days to Decision 140 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 104d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 49
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K961815.
EliA Ro52, EliA Ro60
K210902 · Phadia AB · Jul 2022
LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114
K024218 · Bio-Rad · Jan 2003
LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113
K024232 · Bio-Rad · Jan 2003
LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116
K024223 · Bio-Rad · Jan 2003
LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116
K024226 · Bio-Rad · Jan 2003
ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
K021257 · Diagnostic Products Corp. · Jun 2002