Cleared Traditional

K981871 - C-REACTIVE PROTEIN ELISA

K981871 is the FDA 510(k) clearance for C-REACTIVE PROTEIN ELISA by Diagnostic Systems Laboratories, Inc.. It is a Class 2 Immunology device (product code DCK) cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K981871 · Diagnostic Systems Laboratories, Inc. · Immunology device
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Nov 1998
Decision
165d
Days
Class 2
Risk

K981871 is an FDA 510(k) clearance for the C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on November 9, 1998 after a review of 165 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 Diagnostic Systems Laboratories, Inc. devices

Submission Details

510(k) Number K981871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1998
Decision Date November 09, 1998
Days to Decision 165 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
61d slower than avg
Panel avg: 104d · This submission: 165d
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 81
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K981871.
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
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