Cleared Traditional

K963680 - TARGET MYOGLOBIN TEST

K963680 is the FDA 510(k) clearance for TARGET MYOGLOBIN TEST by Texas Immunology, Inc.. It is a Class 2 Immunology device (product code DDR) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K963680 · Texas Immunology, Inc. · Immunology device
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Feb 1997
Decision
143d
Days
Class 2
Risk

K963680 is an FDA 510(k) clearance for the TARGET MYOGLOBIN TEST. Classified as Myoglobin, Antigen, Antiserum, Control (product code DDR), Class II - Special Controls.

Submitted by Texas Immunology, Inc. (Tyler, US). The FDA issued a Cleared decision on February 6, 1997 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5680 - 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 Texas Immunology, Inc. devices

Submission Details

510(k) Number K963680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1996
Decision Date February 06, 1997
Days to Decision 143 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 104d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDR Myoglobin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5680
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 - DDR Myoglobin, Antigen, Antiserum, Control

All 33
Devices cleared under the same product code (DDR) and FDA review panel - the closest regulatory comparables to K963680.
AIA-PACK MYOGLOBIN ASSAY
K981012 · Tosoh Medics, Inc. · May 1998
STRATUS CS MYOGLOBIN (MYO) TESTPAK
K981102 · Dade Behring, Inc. · Apr 1998
TINAQUANT MYOGLOBIN ASSAY
K972513 · Boehringer Mannheim Corp. · Jul 1997
MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
K962344 · Bayer Corp. · Aug 1996
ACCESS MYOGLOBIN REAGENTS
K951634 · Bio-Rad Laboratories, Inc. · Sep 1995
CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN
K952360 · Princeton BioMeditech Corp. · Aug 1995