Cleared Traditional

K962729 - HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY

K962729 is the FDA 510(k) clearance for HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY by Hycor Biomedical, Inc.. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K962729 · Hycor Biomedical, Inc. · Immunology device
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Mar 1997
Decision
249d
Days
Class 2
Risk

K962729 is an FDA 510(k) clearance for the HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on March 7, 1997 after a review of 249 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5775 - 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 K962729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1996
Decision Date March 07, 1997
Days to Decision 249 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 104d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHR System, Test, Rheumatoid Factor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5775
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 - DHR System, Test, Rheumatoid Factor

All 82
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K962729.
QUANTA LITE RF IGM
K971614 · Inova Diagnostics, Inc. · Jun 1997
TINAQUANT RHEUMATOID FACTOR ASSAY
K971379 · Boehringer Mannheim Corp. · Jun 1997
SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR
K971788 · Beckman Instruments, Inc. · Jun 1997
RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST
K962015 · Teco Diagnostics · Nov 1996
IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
K963048 · Beckman Instruments, Inc. · Nov 1996
HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)
K962836 · Hemagen Diagnostics, Inc. · Sep 1996