Cleared Traditional

K962728 - HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY

K962728 is the FDA 510(k) clearance for HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY by Hycor Biomedical, Inc.. It is a Class 2 Immunology device (product code LLL) cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K962728 · Hycor Biomedical, Inc. · Immunology device
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Mar 1997
Decision
249d
Days
Class 2
Risk

K962728 is an FDA 510(k) clearance for the HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY. 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 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 866.5100 - 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 K962728 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 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 107
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K962728.
HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY
K962720 · Hycor Biomedical, Inc. · Mar 1997
HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY
K962722 · Hycor Biomedical, Inc. · Mar 1997
HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY
K962727 · Hycor Biomedical, Inc. · Mar 1997
HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY
K962731 · Hycor Biomedical, Inc. · Mar 1997
QUANTA LITE ENA 6 ELISA
K961913 · Inova Diagnostics, Inc. · Jul 1996
HYTEC AUTOIMMUNE KITS (SCL-70)
K954894 · Hycor Biomedical, Inc. · Mar 1996