Cleared Traditional

K982121 - ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT

K982121 is an FDA 510(k) clearance for ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) R..., manufactured by Trace Scientific , Ltd.. The device is a Class 2 Immunology device with product code DBM cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K982121 · Trace Scientific , Ltd. · Immunology device
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Sep 1998
Decision
93d
Days
Class 2
Risk

K982121 is an FDA 510(k) clearance for the ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT. Classified as Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (product code DBM), Class II - Special Controls.

Submitted by Trace Scientific , Ltd. (Miami, US). The FDA issued a Cleared decision on September 17, 1998 after a review of 93 days - within the typical 510(k) review window.

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 Trace Scientific , Ltd. devices

FDA 510(k) Submission Details - K982121

510(k) Number K982121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1998
Decision Date September 17, 1998
Days to Decision 93 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
12d faster than avg
Panel avg: 105d · This submission: 93d
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 K982121.
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K971909 · Hemagen Diagnostics, Inc. · Jun 1997
HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA
K962452 · Hycor Biomedical, Inc. · Nov 1996
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K945607 · Elias U.S.A., Inc. · Jan 1995