Cleared Traditional

K972513 - TINAQUANT MYOGLOBIN ASSAY

K972513 is an FDA 510(k) clearance for TINAQUANT MYOGLOBIN ASSAY, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Immunology device with product code DDR cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K972513 · Boehringer Mannheim Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
21d
Days
Class 2
Risk

K972513 is an FDA 510(k) clearance for the TINAQUANT MYOGLOBIN ASSAY. Classified as Myoglobin, Antigen, Antiserum, Control (product code DDR), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on July 28, 1997 after a review of 21 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K972513

510(k) Number K972513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1997
Decision Date July 28, 1997
Days to Decision 21 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
83d faster than avg
Panel avg: 104d · This submission: 21d
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 34
Devices cleared under the same product code (DDR) and FDA review panel - the closest regulatory comparables to K972513.
ELECSYS MYOGLOBIN STAT ASSAY
K983176 · Boehringer Mannheim Corp. · Sep 1998
AIA-PACK MYOGLOBIN ASSAY
K981012 · Tosoh Medics, Inc. · May 1998
STRATUS CS MYOGLOBIN (MYO) TESTPAK
K981102 · Dade Behring, Inc. · Apr 1998
STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY
K965213 · Dade Intl., Inc. · Feb 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