Cleared Traditional

K984145 - OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT

K984145 is an FDA 510(k) clearance for OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC RE..., manufactured by Olympus Diagnostica GmbH. The device is a Class 2 Immunology device with product code DDR cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K984145 · Olympus Diagnostica GmbH · Immunology device
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Dec 1998
Decision
34d
Days
Class 2
Risk

K984145 is an FDA 510(k) clearance for the OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT. Classified as Myoglobin, Antigen, Antiserum, Control (product code DDR), Class II - Special Controls.

Submitted by Olympus Diagnostica GmbH (Melville, US). The FDA issued a Cleared decision on December 23, 1998 after a review of 34 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 Olympus Diagnostica GmbH devices

FDA 510(k) Submission Details - K984145

510(k) Number K984145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1998
Decision Date December 23, 1998
Days to Decision 34 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
71d faster than avg
Panel avg: 105d · This submission: 34d
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 K984145.
K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR
K992976 · Kamiya Biomedical Co. · Nov 1999
IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5
K991796 · Diagnostic Products Corp. · Jun 1999
MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5
K991277 · Diagnostic Products Corp. · Apr 1999
STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK
K984065 · Dade Behring, Inc. · Dec 1998
MYOGLOBIN FLEX REAGENT CARTRIDGE
K984191 · Dade Behring, Inc. · Dec 1998
IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5
K983970 · Diagnostic Products Corp. · Nov 1998