Cleared Traditional

K954996 - TREND AMEBIASIS (E.HISTOLYTICA) SEROLOG...

K954996 is the FDA 510(k) clearance for TREND AMEBIASIS (E.HISTOLYTICA) SEROLOG... by Trend Scientific, Inc.. It is a Class 2 Microbiology device (product code KHW) cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K954996 · Trend Scientific, Inc. · Microbiology device
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Aug 1996
Decision
281d
Days
Class 2
Risk

K954996 is an FDA 510(k) clearance for the TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM. Classified as Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. (product code KHW), Class II - Special Controls.

Submitted by Trend Scientific, Inc. (New Brighton, US). The FDA issued a Cleared decision on August 8, 1996 after a review of 281 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3220 - 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 Trend Scientific, Inc. devices

Submission Details

510(k) Number K954996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1995
Decision Date August 08, 1996
Days to Decision 281 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 102d · This submission: 281d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3220
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 - KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

All 8
Devices cleared under the same product code (KHW) and FDA review panel - the closest regulatory comparables to K954996.
E. HISTOLYTICA QUIK CHEK
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E. HISTOLYTICA II
K994101 · Techlab, Inc. · Dec 1999
E. HISTOLYTICA TEST
K955895 · Techlab, Inc. · Aug 1996
ENTAMOEBA TEST
K944791 · Techlab, Inc. · Mar 1995
AMEBIASIS MICROASSAY
K863811 · Diamedix Corp. · Oct 1986
PDQ AMEBIASIS
K862473 · Diamedix Corp. · Aug 1986