Cleared Traditional

K944505 - DIASTAT ENA SINGLE WELL SCREEN KIT

K944505 is the FDA 510(k) clearance for DIASTAT ENA SINGLE WELL SCREEN KIT by Shield Diagnostics, Ltd.. It is a Class 2 Immunology device (product code LLL) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K944505 · Shield Diagnostics, Ltd. · Immunology device
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Nov 1994
Decision
68d
Days
Class 2
Risk

K944505 is an FDA 510(k) clearance for the DIASTAT ENA SINGLE WELL SCREEN KIT. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on November 21, 1994 after a review of 68 days - a notably fast clearance cycle.

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: 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 Shield Diagnostics, Ltd. devices

Submission Details

510(k) Number K944505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1994
Decision Date November 21, 1994
Days to Decision 68 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 104d · This submission: 68d
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 117
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K944505.
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
QUANTA LITE ENA 5 ELISA KIT
K943076 · Inova Diagnostics, Inc. · Oct 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