Cleared Traditional

K932876 - DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT

K932876 is an FDA 510(k) clearance for DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT, manufactured by Shield Diagnostics, Ltd.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K932876

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
49d slower than avg
Panel avg: 105d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKJ Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K932876.
QUALITROL ANA CONTROL SERUM SET
K961815 · Consolidated Technologies, Inc. · Sep 1996
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