Cleared Traditional

K961815 - QUALITROL ANA CONTROL SERUM SET

K961815 is an FDA 510(k) clearance for QUALITROL ANA CONTROL SERUM SET, manufactured by Consolidated Technologies, Inc.. The device is a Class 2 Immunology device with product code LKJ cleared through the Traditional 510(k) pathway after a 140-day FDA review.

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

FDA 510(k) Submission Details - K961815

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 105d · This submission: 140d
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 36
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K961815.
LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205
K984473 · Bio-Rad · Dec 1998
LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212
K984475 · Bio-Rad · Dec 1998
LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210
K984478 · Bio-Rad · Dec 1998
HYTEC AUTOIMMUNE KIT (SS-A)
K954392 · Hycor Biomedical, Inc. · Dec 1995
HYTEC AUTOIMMUNE KITS (SS-B)
K954891 · Hycor Biomedical, Inc. · Dec 1995
DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT
K932876 · Shield Diagnostics, Ltd. · Nov 1993