Cleared Traditional

K954892 - HYTEC AUTOMIMMUNE KIT (RF)

K954892 is an FDA 510(k) clearance for HYTEC AUTOMIMMUNE KIT (RF), manufactured by Hycor Biomedical, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K954892 · Hycor Biomedical, Inc. · Immunology device
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Dec 1995
Decision
62d
Days
Class 2
Risk

K954892 is an FDA 510(k) clearance for the HYTEC AUTOMIMMUNE KIT (RF). 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 December 26, 1995 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hycor Biomedical, Inc. devices

FDA 510(k) Submission Details - K954892

510(k) Number K954892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1995
Decision Date December 26, 1995
Days to Decision 62 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
43d faster than avg
Panel avg: 105d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHR Device Classification - Class 2, Special Controls

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 111
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K954892.
LIQUICHEK RHEUMATOID FACTOR CONTROL
K960987 · Bio-Rad · Jun 1996
RF IGM ELISA TEST SYSTEM
K961277 · Zeus Scientific, Inc. · May 1996
RF-LATEX SEIKEN REAGENT SYSTEM
K960703 · Globe Management Support, Inc. · Apr 1996
TEST, RHEUMATOID FACTOR
K955086 · Polymedco, Inc. · Dec 1995
OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT
K953520 · Olympus America, Inc. · Aug 1995
EL-RF/3 (IGM-IGG-IGA) KIT
K941398 · Theratest Laboratories, Inc. · Jul 1995