Cleared Traditional

K173212 - Instant-view-PLUS immunochemical Fecal Occult Blood Test (FDA 510(k) Clearance)

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

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

Submission Details

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.

Device Classification

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.