Cleared Traditional

K954897 - HYTEC AUTOIMMUNE KITS (RNP)

K954897 is an FDA 510(k) clearance for HYTEC AUTOIMMUNE KITS (RNP), manufactured by Hycor Biomedical, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K954897

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
80d slower than avg
Panel avg: 105d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKO Device Classification - Class 2, Special Controls

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

All 15
Devices cleared under the same product code (LKO) and FDA review panel - the closest regulatory comparables to K954897.
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
ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY
K954831 · Orgentec · May 1996
SYNELISA U1-SNRNP (68KDA)-ANTIBODIES
K930142 · Elias U.S.A., Inc. · May 1993
IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST
K911849 · General Biometrics, Inc. · May 1991
IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST
K911850 · General Biometrics, Inc. · May 1991