Cleared Traditional

OLYMPUS PK-TP ABSORBENT KIT (K905038) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K905038 · Fujirebio America, Inc. · Microbiology device
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May 1991
Decision
181d
Days
Class 2
Risk

K905038 is an FDA 510(k) clearance for the OLYMPUS PK-TP ABSORBENT KIT. Classified as Antigens, Ha, Treponema Pallidum (product code GMT), Class II - Special Controls.

Submitted by Fujirebio America, Inc. (Fairfield, US). The FDA issued a Cleared decision on May 6, 1991 after a review of 181 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3830 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fujirebio America, Inc. devices

Submission Details

510(k) Number K905038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1990
Decision Date May 06, 1991
Days to Decision 181 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 102d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GMT Antigens, Ha, Treponema Pallidum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3830
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 Microbiology devices follow this clearance model.