Cleared Traditional

K001009 - RANDOX C-REACTIVE PROTEIN

K001009 is an FDA 510(k) clearance for RANDOX C-REACTIVE PROTEIN, manufactured by Randox Laboratories, Ltd.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K001009

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
23d slower than avg
Panel avg: 105d · This submission: 128d
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 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