Cleared Traditional

K943076 - QUANTA LITE ENA 5 ELISA KIT

K943076 is an FDA 510(k) clearance for QUANTA LITE ENA 5 ELISA KIT, manufactured by Inova Diagnostics, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K943076

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
14d slower than avg
Panel avg: 105d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

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 146
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K943076.
HEMAGEN ENA JO-1 KIT (EIA METHOD)
K946124 · Hemagen Diagnostics, Inc. · Feb 1995
ANTI DS-DNA
K943291 · Sigma Diagnostics, Inc. · Dec 1994
DIASTAT ENA SINGLE WELL SCREEN KIT
K944505 · Shield Diagnostics, Ltd. · Nov 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