Cleared Traditional

K981012 - AIA-PACK MYOGLOBIN ASSAY

K981012 is the FDA 510(k) clearance for AIA-PACK MYOGLOBIN ASSAY by Tosoh Medics, Inc.. It is a Class 2 Immunology device (product code DDR) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K981012 · Tosoh Medics, Inc. · Immunology device
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May 1998
Decision
71d
Days
Class 2
Risk

K981012 is an FDA 510(k) clearance for the AIA-PACK MYOGLOBIN ASSAY. Classified as Myoglobin, Antigen, Antiserum, Control (product code DDR), Class II - Special Controls.

Submitted by Tosoh Medics, Inc. (Foster City, US). The FDA issued a Cleared decision on May 28, 1998 after a review of 71 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 Tosoh Medics, Inc. devices

Submission Details

510(k) Number K981012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1998
Decision Date May 28, 1998
Days to Decision 71 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
33d faster than avg
Panel avg: 104d · This submission: 71d
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 32
Devices cleared under the same product code (DDR) and FDA review panel - the closest regulatory comparables to K981012.
IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5
K983970 · Diagnostic Products Corp. · Nov 1998
ABBOTT AXSYM MYOGLOBIN
K983848 · Abbott Laboratories · Nov 1998
ELECSYS MYOGLOBIN STAT ASSAY
K983176 · Boehringer Mannheim Corp. · Sep 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