Cleared Traditional

K911640 - OLYMPUS PK TP(TM) SYSTEM, MODIFICATION

K911640 is an FDA 510(k) clearance for OLYMPUS PK TP(TM) SYSTEM, manufactured by Olympus Corp.. The device is a Class 2 Microbiology device with product code GMT cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K911640 · Olympus Corp. · Microbiology device
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Jul 1991
Decision
107d
Days
Class 2
Risk

K911640 is an FDA 510(k) clearance for the OLYMPUS PK TP(TM) SYSTEM, MODIFICATION. Classified as Antigens, Ha, Treponema Pallidum (product code GMT), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on July 24, 1991 after a review of 107 days - within the typical 510(k) review window.

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 Olympus Corp. devices

FDA 510(k) Submission Details - K911640

510(k) Number K911640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1991
Decision Date July 24, 1991
Days to Decision 107 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 102d · This submission: 107d
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 7
Devices cleared under the same product code (GMT) and FDA review panel - the closest regulatory comparables to K911640.
SERODIA TP-PA
K971502 · Scimedx Tekfile Services · Nov 1997
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
AGGLUTINOTEST-SYPHILIS
K791457 · Volu Sol Medical Industries · Sep 1979