Cleared Traditional

K943076 - QUANTA LITE ENA 5 ELISA KIT

K943076 is the FDA 510(k) clearance for QUANTA LITE ENA 5 ELISA KIT by Inova Diagnostics, Inc.. It is a Class 2 Immunology device (product code LLL) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K943076 · Inova Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
119d
Days
Class 2
Risk

K943076 is an FDA 510(k) clearance for the QUANTA LITE ENA 5 ELISA KIT. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on October 25, 1994 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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

Submission Details

510(k) Number K943076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1994
Decision Date October 25, 1994
Days to Decision 119 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
15d slower than avg
Panel avg: 104d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLL Extractable Antinuclear Antibody, Antigen And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - LLL Extractable Antinuclear Antibody, Antigen And Control

All 116
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K943076.
HEMAGEN ENA SM KIT (EIA METHOD)
K946123 · Hemagen Diagnostics, Inc. · Feb 1995
HEMAGEN ENA JO-1 KIT (EIA METHOD)
K946124 · Hemagen Diagnostics, Inc. · Feb 1995
ANTI DS-DNA
K943291 · Sigma Diagnostics, Inc. · Dec 1994
ANA SCREEN ELISA TEST SYSTEM
K940362 · Zeus Scientific, Inc. · Jul 1994
SYN ENA SCREEN (PIN PLATE)
K940229 · Elias U.S.A., Inc. · May 1994
ELIAS ENA SCREEN (MICROTITER PLATE)
K940622 · Elias U.S.A., Inc. · May 1994