Cleared Traditional

HYTEC AUTOIMMUNE KITS (SS-B) (K954891) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K954891 · Hycor Biomedical, Inc. · Immunology device
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Dec 1995
Decision
98d
Days
Class 2
Risk

K954891 is an FDA 510(k) clearance for the HYTEC AUTOIMMUNE KITS (SS-B). Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), Class II - Special Controls.

Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on December 26, 1995 after a review of 98 days - within the typical 510(k) review window.

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 Hycor Biomedical, Inc. devices

Submission Details

510(k) Number K954891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1995
Decision Date December 26, 1995
Days to Decision 98 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
6d faster than avg
Panel avg: 104d · This submission: 98d
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 49
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K954891.
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LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114
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LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113
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LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116
K024223 · Bio-Rad · Jan 2003
LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116
K024226 · Bio-Rad · Jan 2003
ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
K021257 · Diagnostic Products Corp. · Jun 2002