Cleared Traditional

K961544 - QUALITROL IGAME CONTROLS, LEVELS 1 AND 2

K961544 is an FDA 510(k) clearance for QUALITROL IGAME CONTROLS, manufactured by Consolidated Technologies, Inc.. The device is a Class 1 Immunology device with 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

FDA 510(k) Submission Details - K961544

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 105d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

DGR Device Classification - Class 1, General Controls

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