Cleared Traditional

K971502 - SERODIA TP-PA

K971502 is an FDA 510(k) clearance for SERODIA TP-PA, manufactured by Scimedx Tekfile Services. The device is a Class 2 Microbiology device with product code GMT cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K971502 · Scimedx Tekfile Services · Microbiology device
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Nov 1997
Decision
203d
Days
Class 2
Risk

K971502 is an FDA 510(k) clearance for the SERODIA TP-PA. Classified as Antigens, Ha, Treponema Pallidum (product code GMT), Class II - Special Controls.

Submitted by Scimedx Tekfile Services (Denvill, US). The FDA issued a Cleared decision on November 13, 1997 after a review of 203 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 Scimedx Tekfile Services devices

FDA 510(k) Submission Details - K971502

510(k) Number K971502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1997
Decision Date November 13, 1997
Days to Decision 203 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 102d · This submission: 203d
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 K971502.
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
AGGLUTINOTEST-SYPHILIS
K791457 · Volu Sol Medical Industries · Sep 1979