Cleared Special

K990886 - IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5

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

K990886 · Diagnostic Products Corp. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K990886

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
85d faster than avg
Panel avg: 105d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 119
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K990886.
K-ASSAY CRP
K991224 · Kamiya Biomedical Co. · May 1999
K-ASSAY CRP CALIBRATOR SET
K991210 · Kamiya Biomedical Co. · May 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
K990886 · IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5
Download PDF FDA Summary Diagnostic Products C…