Cleared Traditional

K961545 - QUALITROL RF CONTROLS

K961545 is an FDA 510(k) clearance for QUALITROL RF CONTROLS, manufactured by Consolidated Technologies, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K961545 · Consolidated Technologies, Inc. · Immunology device
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Sep 1996
Decision
155d
Days
Class 2
Risk

K961545 is an FDA 510(k) clearance for the QUALITROL RF CONTROLS. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special 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 866.5775 - 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 - K961545

510(k) Number K961545 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. No clinical trials required.

DHR Device Classification - Class 2, Special Controls

Product Code DHR System, Test, Rheumatoid Factor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5775
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 - DHR System, Test, Rheumatoid Factor

All 111
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K961545.
N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET
K964418 · Kamiya Technology Services · Dec 1996
RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST
K962015 · Teco Diagnostics · Nov 1996
IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
K963048 · Beckman Instruments, Inc. · Nov 1996
HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)
K962836 · Hemagen Diagnostics, Inc. · Sep 1996
RHEUMATOID FACTOR LATEX SLIDE TEST KIT
K961169 · Randox Laboratories, Ltd. · Jun 1996
LIQUICHEK RHEUMATOID FACTOR CONTROL
K960987 · Bio-Rad · Jun 1996