Cleared Traditional

K962452 - HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCH...

K962452 is the FDA 510(k) clearance for HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCH... by Hycor Biomedical, Inc.. It is a Class 2 Immunology device (product code DBM) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K962452 · Hycor Biomedical, Inc. · Immunology device
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Nov 1996
Decision
160d
Days
Class 2
Risk

K962452 is an FDA 510(k) clearance for the HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA. Classified as Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (product code DBM), Class II - Special Controls.

Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on November 25, 1996 after a review of 160 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5090 - 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 K962452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1996
Decision Date November 25, 1996
Days to Decision 160 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
56d slower than avg
Panel avg: 104d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5090
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 - DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

All 14
Devices cleared under the same product code (DBM) and FDA review panel - the closest regulatory comparables to K962452.
BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT
K030238 · The Binding Site, Ltd. · Mar 2003
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT
K982121 · Trace Scientific , Ltd. · Sep 1998
VIRGO AMA ELISA KIT
K971909 · Hemagen Diagnostics, Inc. · Jun 1997
VARELISA M2 ANTIBODIES
K945607 · Elias U.S.A., Inc. · Jan 1995
AYNELISA M2-ANTIBODIES
K930143 · Elias U.S.A., Inc. · May 1993
AUTOANTIBODY SCREEN TEST SYSTEM
K831358 · Zeus Scientific, Inc. · Jun 1983