Cleared Traditional

K912291 - DISTAT ANTI-SCL-70 KIT

K912291 is the FDA 510(k) clearance for DISTAT ANTI-SCL-70 KIT by Shield Diagnostics, Ltd.. It is a Class 2 Immunology device (product code LKJ) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K912291 · Shield Diagnostics, Ltd. · Immunology device
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Jul 1991
Decision
68d
Days
Class 2
Risk

K912291 is an FDA 510(k) clearance for the DISTAT ANTI-SCL-70 KIT. Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), Class II - Special Controls.

Submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on July 30, 1991 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 K912291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1991
Decision Date July 30, 1991
Days to Decision 68 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
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 LKJ Antinuclear Antibody, Antigen, 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 - LKJ Antinuclear Antibody, Antigen, Control

All 27
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K912291.
SYNELISA CENP-B ANTIBODIES
K931255 · Elias U.S.A., Inc. · Sep 1993
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K932302 · Elias U.S.A., Inc. · Aug 1993
SYN ELISA DSDNA ANTIBODIES
K921132 · Elias U.S.A., Inc. · Dec 1992
SERATEST ENA [SCL-70] KIT
K894411 · Hemagen Diagnostics, Inc. · Aug 1989
ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)
K883883 · Immco Diagnostics, Inc. · Oct 1988
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K883949 · Immco Diagnostics, Inc. · Oct 1988