Cleared Traditional

K030044 - EXTENDED RANGE HS CRP KIT, CAT NO:9200

K030044 is an FDA 510(k) clearance for EXTENDED RANGE HS CRP KIT, manufactured by Reference Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code DCK cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K030044 · Reference Diagnostics, Inc. · Chemistry device
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Sep 2003
Decision
267d
Days
Class 2
Risk

K030044 is an FDA 510(k) clearance for the EXTENDED RANGE HS CRP KIT, CAT NO:9200. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Reference Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on September 30, 2003 after a review of 267 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5270 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Reference Diagnostics, Inc. devices

FDA 510(k) Submission Details - K030044

510(k) Number K030044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2003
Decision Date September 30, 2003
Days to Decision 267 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 88d · This submission: 267d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 100
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K030044.
N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET
K040241 · Genzyme Corp. · Jun 2004
CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)
K040579 · Cholestech Corp. · Jun 2004
QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2
K032663 · Instrumentation Laboratory CO · Dec 2003
WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET
K024280 · Wako Chemicals USA, Inc. · Jun 2003
VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
K030626 · Ortho-Clinical Diagnostics, Inc. · Mar 2003
K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR
K023828 · Kamiya Biomedical Co. · Feb 2003