Cleared Traditional

DADE BEHRING N HIGH SENSITIVITY CRP ASSAY (K991385) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K991385 · Dade Behring, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 125
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K991385.
K-ASSAY CRP (Ver.2)
K242170 · Kamiya Biomedical Company, LLC · Apr 2025
Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
K201256 · Procise Diagnostics · Nov 2022
Yumizen C1200 CRP
K192028 · HORIBA ABX SAS · Jun 2020
CRP Vario
K192118 · SENTINEL CH. SpA · Nov 2019
Yumizen C1200 CRP
K191993 · HORIBA ABX SAS · Oct 2019
VISION(R) CRP
K875345 · Abbott Laboratories · Mar 1988