Cleared Traditional

K170728 - E. HISTOLYTICA QUIK CHEK (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K170728 is an FDA 510(k) clearance for the E. HISTOLYTICA QUIK CHEK. This device is classified as a Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. (Class II - Special Controls, product code KHW).

Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on June 7, 2017, 90 days after receiving the submission on March 9, 2017.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3220.

Submission Details

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
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 174d · This submission: 90d
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.