Cleared Traditional

K001009 - RANDOX C-REACTIVE PROTEIN

K001009 is the FDA 510(k) clearance for RANDOX C-REACTIVE PROTEIN by Randox Laboratories, Ltd.. It is a Class 2 Immunology device (product code DCK) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K001009 · Randox Laboratories, Ltd. · Immunology device
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Aug 2000
Decision
128d
Days
Class 2
Risk

K001009 is an FDA 510(k) clearance for the RANDOX C-REACTIVE PROTEIN. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, GB). The FDA issued a Cleared decision on August 4, 2000 after a review of 128 days - within the typical 510(k) review window.

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 Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K001009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2000
Decision Date August 04, 2000
Days to Decision 128 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 104d · This submission: 128d
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 K001009.
K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE
K002558 · Kamiya Biomedical Co. · Oct 2000
C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
K002651 · Pointe Scientific, Inc., · Oct 2000
C-REACTIVE PROTEIN ANTISERUM KIT
K001636 · The Binding Site, Ltd. · Aug 2000
DADE BEHRING N HIGH SENSITIVITY CRP ASSAY
K991385 · Dade Behring, Inc. · Oct 1999
K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC
K992311 · Kamiya Biomedical Co. · Sep 1999
K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B
K992312 · Kamiya Biomedical Co. · Sep 1999