Cleared Special

K994101 - E. HISTOLYTICA II

K994101 is an FDA 510(k) clearance for E. HISTOLYTICA II, manufactured by Techlab, Inc.. The device is a Class 2 Microbiology device with product code KHW cleared through the Special 510(k) pathway after a 15-day FDA review.

K994101 · Techlab, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
15d
Days
Class 2
Risk

K994101 is an FDA 510(k) clearance for the E. HISTOLYTICA II. 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 December 21, 1999 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3220 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K994101

510(k) Number K994101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1999
Decision Date December 21, 1999
Days to Decision 15 days
Submission Type Special
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
87d faster than avg
Panel avg: 102d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

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 17
Devices cleared under the same product code (KHW) and FDA review panel - the closest regulatory comparables to K994101.
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DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA
K900604 · Biovir Laboratories, Inc. · Jul 1990
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K994101 · E. HISTOLYTICA II
Download PDF FDA Summary Techlab, Inc.