Cleared Traditional

K954897 - HYTEC AUTOIMMUNE KITS (RNP)

K954897 is the FDA 510(k) clearance for HYTEC AUTOIMMUNE KITS (RNP) by Hycor Biomedical, Inc.. It is a Class 2 Immunology device (product code LKO) cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K954897 · Hycor Biomedical, Inc. · Immunology device
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Mar 1996
Decision
185d
Days
Class 2
Risk

K954897 is an FDA 510(k) clearance for the HYTEC AUTOIMMUNE KITS (RNP). Classified as Anti-rnp Antibody, Antigen And Control (product code LKO), Class II - Special Controls.

Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on March 22, 1996 after a review of 185 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 Hycor Biomedical, Inc. devices

Submission Details

510(k) Number K954897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1995
Decision Date March 22, 1996
Days to Decision 185 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
81d slower than avg
Panel avg: 104d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKO Anti-rnp 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 - LKO Anti-rnp Antibody, Antigen And Control

Devices cleared under the same product code (LKO) and FDA review panel - the closest regulatory comparables to K954897.
Maverick RNP Assay and Maverick Diagnostic System
K191085 · Genalyte, Inc. · Oct 2019
LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207
K984476 · Bio-Rad · Dec 1998
THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K983465 · Zeus Scientific, Inc. · Nov 1998
SYNELISA U1-SNRNP (68KDA)-ANTIBODIES
K930142 · Elias U.S.A., Inc. · May 1993
ANTI-RNP AND ANTI-SM ANTIBODY TEST
K895338 · Immco Diagnostics, Inc. · Oct 1989