Cleared Traditional

K051564 - OLYMPUS CRP LATEX REAGENT, OSR6199

Also marketed or referenced as:
OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026 OLYMPUS CRP LATEX CALIBRATOR HIGH

K051564 is an FDA 510(k) clearance for OLYMPUS CRP LATEX REAGENT, manufactured by Olympus America, Inc.. The device is a Class 2 Chemistry device with product code NQD cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K051564 · Olympus America, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
69d
Days
Class 2
Risk

K051564 is an FDA 510(k) clearance for the OLYMPUS CRP LATEX REAGENT, OSR6199. Classified as Cardiac C-reactive Protein, Antigen, Antiserum, And Control (product code NQD), Class II - Special Controls.

Submitted by Olympus America, Inc. (Irving, US). The FDA issued a Cleared decision on August 22, 2005 after a review of 69 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Olympus America, Inc. devices

FDA 510(k) Submission Details - K051564

510(k) Number K051564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2005
Decision Date August 22, 2005
Days to Decision 69 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
19d faster than avg
Panel avg: 88d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NQD Device Classification - Class 2, Special Controls

Product Code NQD Cardiac C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
Definition In Vitro Diagnostic Test To Measure C-reactive Protein For The Purpose Of Making Cardiac Risk Assessments.
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 - NQD Cardiac C-reactive Protein, Antigen, Antiserum, And Control

All 18
Devices cleared under the same product code (NQD) and FDA review panel - the closest regulatory comparables to K051564.
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK
K060369 · Dade Behring, Inc. · May 2006
C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS
K053603 · Roche Diagnostics Corp. · Feb 2006
DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE
K053109 · Dade Behring, Inc. · Dec 2005
TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)
K042485 · Roche Diagnostics Corp. · Oct 2004
VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS
K041799 · Ortho-Clinical Diagnostics, Inc. · Aug 2004
OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
K041668 · Olympus America, Inc. · Aug 2004