Cleared Traditional

K973692 - UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUA...

K973692 is the FDA 510(k) clearance for UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUA... by United Biotech, Inc.. It is a Class 2 Immunology device (product code DCK) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K973692 · United Biotech, Inc. · Immunology device
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Feb 1998
Decision
136d
Days
Class 2
Risk

K973692 is an FDA 510(k) clearance for the UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by United Biotech, Inc. (Mountain View, US). The FDA issued a Cleared decision on February 9, 1998 after a review of 136 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 United Biotech, Inc. devices

Submission Details

510(k) Number K973692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1997
Decision Date February 09, 1998
Days to Decision 136 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
32d slower than avg
Panel avg: 104d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 82
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K973692.
C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100
K981871 · Diagnostic Systems Laboratories, Inc. · Nov 1998
ROCHE CRP T CONTROL N
K982087 · Roche Diagnostic Systems, Inc. · Aug 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
K981638 · Beckman Coulter, Inc. · Jun 1998
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT
K974050 · Beckman Instruments, Inc. · Nov 1997
CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST
K972160 · Trinity Laboratories, Inc. · Aug 1997
C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST
K962019 · Teco Diagnostics · Nov 1996