Cleared Traditional

K954893 - HYTEC AUTOMIMMUNE KIT (DS-DNA)

K954893 is the FDA 510(k) clearance for HYTEC AUTOMIMMUNE KIT (DS-DNA) by Hycor Biomedical, Inc.. It is a Class 2 Immunology device (product code LRM) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K954893 · Hycor Biomedical, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
147d
Days
Class 2
Risk

K954893 is an FDA 510(k) clearance for the HYTEC AUTOMIMMUNE KIT (DS-DNA). Classified as Anti-dna Antibody (enzyme-labeled), Antigen, Control (product code LRM), Class II - Special Controls.

Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on March 20, 1996 after a review of 147 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 K954893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1995
Decision Date March 20, 1996
Days to Decision 147 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
43d slower than avg
Panel avg: 104d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRM Anti-dna Antibody (enzyme-labeled), 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 - LRM Anti-dna Antibody (enzyme-labeled), Antigen, Control

All 12
Devices cleared under the same product code (LRM) and FDA review panel - the closest regulatory comparables to K954893.
THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET
K983422 · Zeus Scientific, Inc. · Nov 1998
IS-DSDNA TEST SYSTEM
K974694 · Diamedix Corp. · Mar 1998
HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY
K962730 · Hycor Biomedical, Inc. · Mar 1997
VARELISA COMBINED DNA ANTIBODIES EIA
K944334 · Elias U.S.A., Inc. · Apr 1995
VARELISA DSDNA ANTIBODIES (FARR VERSION)
K950031 · Elias U.S.A., Inc. · Mar 1995
ANTI-DNA MICROASSAY
K912020 · Diamedix Corp. · Sep 1991