Cleared Traditional

K953926 - LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM

K953926 is an FDA 510(k) clearance for LINICAL PROTEIN III CALIBRATION VERIFIE..., manufactured by International Enzymes, Inc.. The device is a Class 2 Immunology device with product code DCK cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K953926 · International Enzymes, Inc. · Immunology device
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Sep 1995
Decision
31d
Days
Class 2
Risk

K953926 is an FDA 510(k) clearance for the LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEI.... Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by International Enzymes, Inc. (San Marcos, US). The FDA issued a Cleared decision on September 15, 1995 after a review of 31 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all International Enzymes, Inc. devices

FDA 510(k) Submission Details - K953926

510(k) Number K953926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1995
Decision Date September 15, 1995
Days to Decision 31 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
74d faster than avg
Panel avg: 105d · This submission: 31d
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 104
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K953926.
HEMAGEN CRP 150 KIT (EIA METHOD)
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WAKO AUTOKIT CRP NEW
K955156 · Wako Chemicals USA, Inc. · Feb 1996
C-REACTIVE PROTEIN LATEX KIT
K954447 · Randox Laboratories, Ltd. · Dec 1995
HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION)
K953207 · The Binding Site, Ltd. · Aug 1995
EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP)
K953197 · Johnson & Johnson Clinical Diagnostics, Inc. · Jul 1995
C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR
K953212 · Randox Laboratories, Ltd. · Jul 1995