Cleared Traditional

K954890 - HYTEC AUTOMMUNE KIT (ENA)

K954890 is an FDA 510(k) clearance for HYTEC AUTOMMUNE KIT (ENA), manufactured by Hycor Biomedical, Inc.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K954890 · Hycor Biomedical, Inc. · Immunology device
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Dec 1995
Decision
62d
Days
Class 2
Risk

K954890 is an FDA 510(k) clearance for the HYTEC AUTOMMUNE KIT (ENA). Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), 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 866.5100 - 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: 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 - K954890

510(k) Number K954890 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.

LLL Device Classification - Class 2, Special Controls

Product Code LLL Extractable Antinuclear 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 - LLL Extractable Antinuclear Antibody, Antigen And Control

All 146
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K954890.
HYTEC AUTOIMMUNE KIT (JO-1)
K954895 · Hycor Biomedical, Inc. · Mar 1996
ORGENTEC ENASCREEN PIN IMMUNO ASSAY
K955133 · Orgentec · Mar 1996
ORGENTEC ENASCREEN ELISA ASSAY
K955134 · Orgentec · Mar 1996
HEMAGEN ENA SCREENING KIT (EIA METHOD)
K952076 · Hemagen Diagnostics, Inc. · Jun 1995
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
K952077 · Hemagen Diagnostics, Inc. · Jun 1995
HEMAGEN ENA SM/RMP KIT (EIA METHOD)
K950414 · Hemagen Diagnostics, Inc. · Mar 1995