Cleared Traditional

K961829 - QUALITROL CRP CONTROL SET

K961829 is an FDA 510(k) clearance for QUALITROL CRP CONTROL SET, manufactured by Consolidated Technologies, Inc.. The device is a Class 2 Immunology device with product code DCK cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K961829 · Consolidated Technologies, Inc. · Immunology device
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Aug 1996
Decision
98d
Days
Class 2
Risk

K961829 is an FDA 510(k) clearance for the QUALITROL CRP CONTROL SET. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Consolidated Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on August 19, 1996 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - 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 - K961829

510(k) Number K961829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1996
Decision Date August 19, 1996
Days to Decision 98 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
7d faster than avg
Panel avg: 105d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCK Device Classification - Class 2, Special Controls

Product Code DCK C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
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 - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 105
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K961829.
C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT
K962049 · Polymedco, Inc. · Dec 1996
C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST
K962019 · Teco Diagnostics · Nov 1996
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
K963061 · Beckman Instruments, Inc. · Nov 1996
N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2
K962373 · Behring Diagnostics, Inc. · Jul 1996
N LATEX CRP MONO REAGENT
K962523 · Behring Diagnostics, Inc. · Jul 1996
CRP-LATEX SEIKEN XR REAGENT SYSTEM
K960702 · Globe Management Support, Inc. · Apr 1996