Cleared Traditional

K974325 - CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN

K974325 is an FDA 510(k) clearance for CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN, manufactured by Chiron Diagnostics Corp.. The device is a Class 2 Chemistry device with product code DDR cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K974325 · Chiron Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
20d
Days
Class 2
Risk

K974325 is an FDA 510(k) clearance for the CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN. Classified as Myoglobin, Antigen, Antiserum, Control (product code DDR), Class II - Special Controls.

Submitted by Chiron Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on December 8, 1997 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5680 - the FDA in vitro diagnostics and chemistry 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 Chiron Diagnostics Corp. devices

FDA 510(k) Submission Details - K974325

510(k) Number K974325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1997
Decision Date December 08, 1997
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 88d · This submission: 20d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DDR Myoglobin, Antigen, Antiserum, Control

All 36
Devices cleared under the same product code (DDR) and FDA review panel - the closest regulatory comparables to K974325.
ELECSYS MYOGLOBIN STAT ASSAY
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STRATUS CS MYOGLOBIN (MYO) TESTPAK
K981102 · Dade Behring, Inc. · Apr 1998
TINAQUANT MYOGLOBIN ASSAY
K972513 · Boehringer Mannheim Corp. · Jul 1997
STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY
K965213 · Dade Intl., Inc. · Feb 1997
TARGET MYOGLOBIN TEST
K963680 · Texas Immunology, Inc. · Feb 1997