Cleared Traditional

K981871 - C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100

K981871 is an FDA 510(k) clearance for C-REACTIVE PROTEIN ELISA, manufactured by Diagnostic Systems Laboratories, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K981871

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
60d slower than avg
Panel avg: 105d · This submission: 165d
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 105
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
UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE
K973692 · United Biotech, Inc. · Feb 1998