Cleared Traditional

K905038 - OLYMPUS PK-TP ABSORBENT KIT

K905038 is an FDA 510(k) clearance for OLYMPUS PK-TP ABSORBENT KIT, manufactured by Fujirebio America, Inc.. The device is a Class 2 Microbiology device with product code GMT cleared through the Traditional 510(k) pathway after a 181-day FDA review.

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

FDA 510(k) Submission Details - K905038

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.

GMT Device Classification - Class 2, Special Controls

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.

Regulatory Peers - GMT Antigens, Ha, Treponema Pallidum

All 8
Devices cleared under the same product code (GMT) and FDA review panel - the closest regulatory comparables to K905038.
SERODIA TP-PA
K971502 · Scimedx Tekfile Services · Nov 1997
OLYMPUS PK TP(TM) SYSTEM, MODIFICATION
K911640 · Olympus Corp. · Jul 1991
MODIFIED PK TP CONTROL
K911266 · Olympus Corp. · May 1991
CELLOGNOST SYPHILIS H
K896410 · Behring Diagnostics, Inc. · May 1990
OLYMPUS PK(TM) TP
K893124 · Fujirebio Diagnostics,Inc. · Nov 1989
BACTO-HATTS
K791897 · Difco Laboratories, Inc. · Nov 1979