Cleared Traditional

K991385 - DADE BEHRING N HIGH SENSITIVITY CRP ASSAY

K991385 is the FDA 510(k) clearance for DADE BEHRING N HIGH SENSITIVITY CRP ASSAY by Dade Behring, Inc.. It is a Class 2 Immunology device (product code DCK) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K991385 · Dade Behring, Inc. · Immunology device
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Oct 1999
Decision
187d
Days
Class 2
Risk

K991385 is an FDA 510(k) clearance for the DADE BEHRING N HIGH SENSITIVITY CRP ASSAY. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on October 25, 1999 after a review of 187 days - an extended review 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: 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 Dade Behring, Inc. devices

Submission Details

510(k) Number K991385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1999
Decision Date October 25, 1999
Days to Decision 187 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 104d · This submission: 187d
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 66
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K991385.
C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
K002651 · Pointe Scientific, Inc., · Oct 2000
C-REACTIVE PROTEIN ANTISERUM KIT
K001636 · The Binding Site, Ltd. · Aug 2000
RANDOX C-REACTIVE PROTEIN
K001009 · Randox Laboratories, Ltd. · Aug 2000
ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT
K990704 · Beckman Coulter, Inc. · May 1999
IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5
K990886 · Diagnostic Products Corp. · Apr 1999
IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5
K984132 · Diagnostic Products Corp. · Jan 1999