Cleared Traditional

K961544 - QUALITROL IGAME CONTROLS

K961544 is the FDA 510(k) clearance for QUALITROL IGAME CONTROLS by Consolidated Technologies, Inc.. It is a Class 1 Immunology device (product code DGR) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K961544 · Consolidated Technologies, Inc. · Immunology device
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Sep 1996
Decision
155d
Days
Class 1
Risk

K961544 is an FDA 510(k) clearance for the QUALITROL IGAME CONTROLS, LEVELS 1 AND 2. Classified as Whole Human Serum, Antigen, Antiserum, Control (product code DGR), Class I - General Controls.

Submitted by Consolidated Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on September 24, 1996 after a review of 155 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5700 - 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 K961544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1996
Decision Date September 24, 1996
Days to Decision 155 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
51d slower than avg
Panel avg: 104d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DGR Whole Human Serum, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5700
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DGR Whole Human Serum, Antigen, Antiserum, Control

Devices cleared under the same product code (DGR) and FDA review panel - the closest regulatory comparables to K961544.
PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL
K902220 · Boehringer Mannheim Corp. · Sep 1990
LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II
K865014 · Bio-Rad · Jan 1987
RADIOASSAY, CONTROL SERUM I, II, III
K790298 · Kallestad Laboratories, Inc. · Apr 1979
ICS NORMAL CONTROL SERUM
K781355 · Beckman Instruments, Inc. · Aug 1978