Cleared Special

K990886 - IMMULITE C-REACTIVE PROTEIN

K990886 is the FDA 510(k) clearance for IMMULITE C-REACTIVE PROTEIN by Diagnostic Products Corp.. It is a Class 2 Immunology device (product code DCK) cleared through the Special 510(k) pathway after a 20-day FDA review.

K990886 · Diagnostic Products Corp. · Immunology device
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Apr 1999
Decision
20d
Days
Class 2
Risk

K990886 is an FDA 510(k) clearance for the IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on April 6, 1999 after a review of 20 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Diagnostic Products Corp. devices

Submission Details

510(k) Number K990886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1999
Decision Date April 06, 1999
Days to Decision 20 days
Submission Type Special
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
84d faster than avg
Panel avg: 104d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 67
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K990886.
RANDOX C-REACTIVE PROTEIN
K001009 · Randox Laboratories, Ltd. · Aug 2000
DADE BEHRING N HIGH SENSITIVITY CRP ASSAY
K991385 · Dade Behring, Inc. · Oct 1999
ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT
K990704 · Beckman Coulter, Inc. · May 1999
IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5
K984132 · Diagnostic Products Corp. · Jan 1999
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