Cleared Traditional

K932876 - DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT

K932876 is the FDA 510(k) clearance for DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT by Shield Diagnostics, Ltd.. It is a Class 2 Immunology device (product code LKJ) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K932876 · Shield Diagnostics, Ltd. · Immunology device
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Nov 1993
Decision
154d
Days
Class 2
Risk

K932876 is an FDA 510(k) clearance for the DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) 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 November 15, 1993 after a review of 154 days - an extended review 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: 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 Shield Diagnostics, Ltd. devices

Submission Details

510(k) Number K932876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1993
Decision Date November 15, 1993
Days to Decision 154 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
50d slower than avg
Panel avg: 104d · This submission: 154d
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 K932876.
LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210
K984478 · Bio-Rad · Dec 1998
HYTEC AUTOIMMUNE KIT (SS-A)
K954392 · Hycor Biomedical, Inc. · Dec 1995
HYTEC AUTOIMMUNE KITS (SS-B)
K954891 · Hycor Biomedical, Inc. · Dec 1995
SYNELISA CENP-B ANTIBODIES
K931255 · Elias U.S.A., Inc. · Sep 1993
SYLNELISA HISTONE ANTIBODIES
K932302 · Elias U.S.A., Inc. · Aug 1993
SYN ELISA DSDNA ANTIBODIES
K921132 · Elias U.S.A., Inc. · Dec 1992