Cleared Traditional

K905192 - DIASTAT ANTI-SM/RNP

K905192 is the FDA 510(k) clearance for DIASTAT ANTI-SM/RNP by Shield Diagnostics, Ltd.. It is a Class 2 Immunology device (product code LKP) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K905192 · Shield Diagnostics, Ltd. · Immunology device
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Dec 1990
Decision
18d
Days
Class 2
Risk

K905192 is an FDA 510(k) clearance for the DIASTAT ANTI-SM/RNP. Classified as Anti-sm Antibody, Antigen And Control (product code LKP), 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

Submission Details

510(k) Number K905192 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
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 104d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKP Anti-sm 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 - LKP Anti-sm Antibody, Antigen And Control

All 9
Devices cleared under the same product code (LKP) and FDA review panel - the closest regulatory comparables to K905192.
THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO
K983420 · Zeus Scientific, Inc. · Nov 1998
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K954896 · Hycor Biomedical, Inc. · Mar 1996
SYNELISA SM ABS/RNP-SM ABS
K930141 · Elias U.S.A., Inc. · May 1993
ENZYMATIC ACETAMINOPHEN ASSAY
K841930 · Diagnostic Chemicals, Ltd. (Usa) · Jun 1984