Cleared Traditional

K011855 - WAMPOLE HS-CRP ELISA

K011855 is an FDA 510(k) clearance for WAMPOLE HS-CRP ELISA, manufactured by Carter-Wallace, Inc.. The device is a Class 2 Chemistry device with product code DCN cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K011855 · Carter-Wallace, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
209d
Days
Class 2
Risk

K011855 is an FDA 510(k) clearance for the WAMPOLE HS-CRP ELISA. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Carter-Wallace, Inc. (Cranbury, US). The FDA issued a Cleared decision on January 8, 2002 after a review of 209 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.

FDA 510(k) Submission Details - K011855

510(k) Number K011855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2001
Decision Date January 08, 2002
Days to Decision 209 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 89d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCN Device Classification - Class 2, Special Controls

Product Code DCN System, Test, C-reactive Protein
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 - DCN System, Test, C-reactive Protein

All 69
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K011855.
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT
K021572 · Beckman Coulter, Inc. · Jul 2002
CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510
K021882 · Good Biotech Corp. · Jul 2002
CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010
K020603 · Good Biotech Corp. · Jun 2002
BAYER ADVIA IMS SYSTEM
K012337 · Bayer Corp. · Dec 2001
CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT
K011958 · Denka Seiken'S · Dec 2001
CRP HS TEST SYSTEM
K003400 · Roche Diagnostics Corp. · May 2001
K011855 · WAMPOLE HS-CRP ELISA
Download PDF FDA Summary Carter-Wallace, Inc.