Cleared Traditional

K954996 - TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM

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

K954996 · Trend Scientific, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K954996

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
Combination Product No
PCCP Authorized No
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.

KHW Device Classification - Class 2, Special Controls

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
K170728 · Techlab, Inc. · Jun 2017
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