Cleared Traditional

K965213 - STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY

K965213 is an FDA 510(k) clearance for STRATUS MYOGLOBIN GLUOROMETRIC ENZYME I..., manufactured by Dade Intl., Inc.. The device is a Class 2 Immunology device with product code DDR cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K965213 · Dade Intl., Inc. · Immunology device
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Feb 1997
Decision
42d
Days
Class 2
Risk

K965213 is an FDA 510(k) clearance for the STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY. Classified as Myoglobin, Antigen, Antiserum, Control (product code DDR), Class II - Special Controls.

Submitted by Dade Intl., Inc. (Miami, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 42 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade Intl., Inc. devices

FDA 510(k) Submission Details - K965213

510(k) Number K965213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1996
Decision Date February 10, 1997
Days to Decision 42 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 105d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDR Device Classification - Class 2, Special Controls

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 39
Devices cleared under the same product code (DDR) and FDA review panel - the closest regulatory comparables to K965213.
STRATUS CS MYOGLOBIN (MYO) TESTPAK
K981102 · Dade Behring, Inc. · Apr 1998
CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN
K974325 · Chiron Diagnostics Corp. · Dec 1997
TINAQUANT MYOGLOBIN ASSAY
K972513 · Boehringer Mannheim Corp. · Jul 1997
TARGET MYOGLOBIN TEST
K963680 · Texas Immunology, Inc. · Feb 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