Cleared Traditional

K863730 - MYOLEX

K863730 is an FDA 510(k) clearance for MYOLEX, manufactured by Orion Corp.. The device is a Class 2 Immunology device with product code DDR cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K863730 · Orion Corp. · Immunology device
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Oct 1986
Decision
22d
Days
Class 2
Risk

K863730 is an FDA 510(k) clearance for the MYOLEX. Classified as Myoglobin, Antigen, Antiserum, Control (product code DDR), Class II - Special Controls.

Submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on October 15, 1986 after a review of 22 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 Orion Corp. devices

FDA 510(k) Submission Details - K863730

510(k) Number K863730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1986
Decision Date October 15, 1986
Days to Decision 22 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 105d · This submission: 22d
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 37
Devices cleared under the same product code (DDR) and FDA review panel - the closest regulatory comparables to K863730.
TURBIQUANT MYOGLOBIN
K905202 · Behring Diagnostics, Inc. · Dec 1990
TURBIQUANT MYOGLOBIN
K903687 · Behring Diagnostics, Inc. · Oct 1990
NA LATEX MYOGLOBIN TEST
K902154 · Behring Diagnostics, Inc. · Jun 1990
HEMAGGLUTINATION INHIBITION TEST
K772095 · Miles Laboratories, Inc. · Jan 1978
ANTISERA TO HUMAN FAB FRAGMENT
K771242 · Kent Laboratories, Inc. · Aug 1977