Cleared Traditional

K791461 - AGGLUTINOTEST-C-REACTIVE PROTEIN

K791461 is an FDA 510(k) clearance for AGGLUTINOTEST-C-REACTIVE PROTEIN, manufactured by Volu Sol Medical Industries. The device is a Class 2 Immunology device with product code DCK cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K791461 · Volu Sol Medical Industries · Immunology device
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Dec 1979
Decision
147d
Days
Class 2
Risk

K791461 is an FDA 510(k) clearance for the AGGLUTINOTEST-C-REACTIVE PROTEIN. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on December 31, 1979 after a review of 147 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 Volu Sol Medical Industries devices

FDA 510(k) Submission Details - K791461

510(k) Number K791461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1979
Decision Date December 31, 1979
Days to Decision 147 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 105d · This submission: 147d
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 K791461.
C-REACTIVE PROTEIN CONTROL
K821412 · Syva Co. · Jul 1982
QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG.
K821984 · Kallestad Laboratories, Inc. · Jul 1982
QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R.
K811617 · Kallestad Laboratories, Inc. · Jun 1981
HUMAN, C-REACTIVE PROTEIN (CRP)
K791650 · Beckman Instruments, Inc. · Sep 1979
TEST, SLIDE FOR C-REATIVE PROTEIN
K760354 · Icl Scientific · Aug 1976
TEST, C-REATIVE PROTEIN, LATEX SLIDE
K760035 · Gamma Biologicals, Inc. · Aug 1976