Cleared Traditional

K052264 - QUANTA LITE CCP3 IGG ELISA

K052264 is an FDA 510(k) clearance for QUANTA LITE CCP3 IGG ELISA, manufactured by Inova Diagnostics, Inc.. The device is a Class 2 Immunology device with product code NHX cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K052264 · Inova Diagnostics, Inc. · Immunology device
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Nov 2005
Decision
96d
Days
Class 2
Risk

K052264 is an FDA 510(k) clearance for the QUANTA LITE CCP3 IGG ELISA. Classified as Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (product code NHX), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on November 23, 2005 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5775 - 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 Inova Diagnostics, Inc. devices

FDA 510(k) Submission Details - K052264

510(k) Number K052264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2005
Decision Date November 23, 2005
Days to Decision 96 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
9d faster than avg
Panel avg: 105d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHX Device Classification - Class 2, Special Controls

Product Code NHX Antibodies, Anti-cyclic Citrullinated Peptide (ccp)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5775
Definition The Device Is Used For The Detection Of Anti-cyclic Citrullinated Peptide (ccp) Antibodies In Human Serum Or Plasma As An Aid In The Diagnosis Of Rheumatoid Arthritis.
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 - NHX Antibodies, Anti-cyclic Citrullinated Peptide (ccp)

All 15
Devices cleared under the same product code (NHX) and FDA review panel - the closest regulatory comparables to K052264.
QUANTA LITE CCP3.1 IGG/IGA ELISA
K072944 · Inova Diagnostics, Inc. · Mar 2008
AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10
K063347 · Axis-Shield Diagnostics, Ltd. · Mar 2007
IMMUNOSCAN RA ANTI-CCP TEST SYSTEM
K052133 · Eurodiagnostica · Dec 2005
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA
K023285 · Axis-Shield Diagnostics, Ltd. · Oct 2002
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
K021516 · Axis-Shield Diagnostics, Ltd. · Jul 2002
QUANTA LITE CCP ELISA
K020414 · Inova Diagnostics, Inc. · Apr 2002