Cleared Traditional

K962452 - HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA

K962452 is an FDA 510(k) clearance for HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCH..., manufactured by Hycor Biomedical, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K962452

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
55d slower than avg
Panel avg: 105d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBM Device Classification - Class 2, Special Controls

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 18
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
DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT
K921183 · Shield Diagnostics, Ltd. · Jun 1992