Cleared Traditional

K173212 - Instant-view-PLUS immunochemical Fecal Occult Blood Test

K173212 is an FDA 510(k) clearance for Instant-view-PLUS immunochemical Fecal ..., manufactured by Alfa Scientific Designs, Inc.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K173212 · Alfa Scientific Designs, Inc. · Hematology device
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Feb 2018
Decision
136d
Days
Class 2
Risk

K173212 is an FDA 510(k) clearance for the Instant-view-PLUS immunochemical Fecal Occult Blood Test. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Alfa Scientific Designs, Inc. (Powat, US). The FDA issued a Cleared decision on February 15, 2018 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6550 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alfa Scientific Designs, Inc. devices

FDA 510(k) Submission Details - K173212

510(k) Number K173212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2017
Decision Date February 15, 2018
Days to Decision 136 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 113d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHE Device Classification - Class 2, Special Controls

Product Code KHE Reagent, Occult Blood
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6550
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 Hematology devices follow this clearance model.

Regulatory Peers - KHE Reagent, Occult Blood

All 52
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K173212.
InSure ONE
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K171484 · Immunostics Inc., · Jun 2017
Wondfo One Step Fecal Occult Blood (FOB) Test
K162333 · Guangzhou Wondfo Biotech Co., Ltd. · May 2017
hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
K163554 · Immunostics Inc., · Jan 2017
OC-Light S FIT
K143325 · Eiken Chemical Co., Ltd. · Aug 2015
OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT
K121397 · SEKISUI Diagnostics, LLC · Dec 2012