Cleared Traditional

K070660 - INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST

K070660 is an FDA 510(k) clearance for INSTANT-VIEW FECAL OCCULT BLOOD (FOB) R..., 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 104-day FDA review.

K070660 · Alfa Scientific Designs, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
104d
Days
Class 2
Risk

K070660 is an FDA 510(k) clearance for the INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID 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 June 21, 2007 after a review of 104 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.

FDA 510(k) Submission Details - K070660

510(k) Number K070660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2007
Decision Date June 21, 2007
Days to Decision 104 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
9d faster than avg
Panel avg: 113d · This submission: 104d
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 96
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K070660.
HEMOCCULT ICT
K080812 · Beckman Coulter, Inc. · Jun 2008
DBEST ONE STEP OCCULT BLOOD TEST KITS
K071242 · Ameritek USA, Inc. · Mar 2008
FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE)
K073431 · Tianjin New Bay Bioresearch Co., Ltd. · Jan 2008
FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST
K063693 · New Bay Bioresearch Co. , Ltd. · May 2007
INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE
K063673 · Innovacon, Inc. · Mar 2007
OCCULTECH FECAL OCCULT BLOOD RAPID TEST
K060953 · Yd Diagnostics Corp. · Sep 2006
K070660 · INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
Download PDF FDA Summary Alfa Scientific Desig…