Cleared Traditional

K963139 - OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT

K963139 is an FDA 510(k) clearance for OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC..., manufactured by Olympus America, Inc.. The device is a Class 2 Immunology device with product code DDD cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K963139 · Olympus America, Inc. · Immunology device
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Feb 1997
Decision
178d
Days
Class 2
Risk

K963139 is an FDA 510(k) clearance for the OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT. Classified as Transferrin, Rhodamine, Antigen, Antiserum, Control (product code DDD), Class II - Special Controls.

Submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on February 6, 1997 after a review of 178 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5880 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus America, Inc. devices

FDA 510(k) Submission Details - K963139

510(k) Number K963139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1996
Decision Date February 06, 1997
Days to Decision 178 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
73d slower than avg
Panel avg: 105d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDD Device Classification - Class 2, Special Controls

Product Code DDD Transferrin, Rhodamine, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5880
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.