Cleared Traditional

K973692 - UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE

K973692 is an FDA 510(k) clearance for UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUA..., manufactured by United Biotech, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K973692

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 105d · This submission: 136d
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 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
N-ASSAY TIA MULTI CRP CALIBRATOR SET
K965110 · Crestat Diagnostics, Inc. · Jul 1997