Cleared Traditional

K170728 - E. HISTOLYTICA QUIK CHEK

K170728 is an FDA 510(k) clearance for E. HISTOLYTICA QUIK CHEK, 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 90-day FDA review.

K170728 · Techlab, Inc. · Microbiology device
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Jun 2017
Decision
90d
Days
Class 2
Risk

K170728 is an FDA 510(k) clearance for the E. HISTOLYTICA QUIK CHEK. 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 June 7, 2017 after a review of 90 days - within the typical 510(k) review window.

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 - K170728

510(k) Number K170728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2017
Decision Date June 07, 2017
Days to Decision 90 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
12d faster than avg
Panel avg: 102d · This submission: 90d
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 K170728.
E. HISTOLYTICA II
K994101 · Techlab, Inc. · Dec 1999
E. HISTOLYTICA TEST
K955895 · Techlab, Inc. · Aug 1996
TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM
K954996 · Trend Scientific, Inc. · Aug 1996
ENTAMOEBA TEST
K944791 · Techlab, Inc. · Mar 1995
AMEBIASIS MICROASSAY
K863811 · Diamedix Corp. · Oct 1986
PDQ AMEBIASIS
K862473 · Diamedix Corp. · Aug 1986