Cleared Traditional

K905190 - DIASTAT ENA PROFILE

K905190 is an FDA 510(k) clearance for DIASTAT ENA PROFILE, manufactured by Shield Diagnostics, Ltd.. The device is a Class 2 Immunology device with product code LJM cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K905190 · Shield Diagnostics, Ltd. · Immunology device
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Dec 1990
Decision
18d
Days
Class 2
Risk

K905190 is an FDA 510(k) clearance for the DIASTAT ENA PROFILE. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Shield Diagnostics, Ltd. (Scotland, KN). The FDA issued a Cleared decision on December 7, 1990 after a review of 18 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

FDA 510(k) Submission Details - K905190

510(k) Number K905190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1990
Decision Date December 07, 1990
Days to Decision 18 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 105d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJM Device Classification - Class 2, Special Controls

Product Code LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
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 - LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 79
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K905190.
DIASTAT ANTI-HISTONE KIT
K920616 · Shield Diagnostics, Ltd. · Jul 1992
HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)
K915272 · Hemagen Diagnostics, Inc. · Mar 1992
UBI MAGIWEL(TM) ANA QUANTITATIVE
K910033 · United Biotech, Inc. · Jan 1991
ANTI-SCI-70 MICROASSAY
K902915 · Diamedix Corp. · Sep 1990
IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2
K900072 · General Biometrics, Inc. · Jan 1990
IMMUNODOT AUTOIMMUNE SCREENING PANEL 1
K896347 · General Biometrics, Inc. · Dec 1989