Cleared Traditional

K944791 - ENTAMOEBA TEST

K944791 is an FDA 510(k) clearance for ENTAMOEBA TEST, manufactured by Techlab, Inc.. The device is a Class 2 Microbiology device with product code KHW cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K944791 · Techlab, Inc. · Microbiology device
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Mar 1995
Decision
162d
Days
Class 2
Risk

K944791 is an FDA 510(k) clearance for the ENTAMOEBA TEST. Classified as Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. (product code KHW), Class II - Special Controls.

Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on March 9, 1995 after a review of 162 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 Techlab, Inc. devices

FDA 510(k) Submission Details - K944791

510(k) Number K944791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1994
Decision Date March 09, 1995
Days to Decision 162 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
60d slower than avg
Panel avg: 102d · This submission: 162d
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 K944791.
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AMEBIASIS MICROASSAY
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PDQ AMEBIASIS
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K853448 · Hillcrest Biologicals · Aug 1985