Cleared Traditional

K020414 - QUANTA LITE CCP ELISA

K020414 is an FDA 510(k) clearance for QUANTA LITE CCP 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 81-day FDA review.

K020414 · Inova Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
81d
Days
Class 2
Risk

K020414 is an FDA 510(k) clearance for the QUANTA LITE CCP 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 April 29, 2002 after a review of 81 days - a notably fast clearance cycle.

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: 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 Inova Diagnostics, Inc. devices

FDA 510(k) Submission Details - K020414

510(k) Number K020414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2002
Decision Date April 29, 2002
Days to Decision 81 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
24d faster than avg
Panel avg: 105d · This submission: 81d
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 14
Devices cleared under the same product code (NHX) and FDA review panel - the closest regulatory comparables to K020414.
QUANTA LITE CCP3 IGG ELISA
K052264 · Inova Diagnostics, Inc. · Nov 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