Cleared Traditional

K071242 - DBEST ONE STEP OCCULT BLOOD TEST KITS

K071242 is an FDA 510(k) clearance for DBEST ONE STEP OCCULT BLOOD TEST KITS, manufactured by Ameritek USA, Inc.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K071242 · Ameritek USA, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
308d
Days
Class 2
Risk

K071242 is an FDA 510(k) clearance for the DBEST ONE STEP OCCULT BLOOD TEST KITS. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Ameritek USA, Inc. (Everett, US). The FDA issued a Cleared decision on March 6, 2008 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K071242

510(k) Number K071242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2007
Decision Date March 06, 2008
Days to Decision 308 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 113d · This submission: 308d
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 K071242.
IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
K100031 · Ind Diagnostic, Inc. · Jul 2010
BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
K100817 · Princeton BioMeditech Corp. · Jul 2010
HEMOCCULT ICT
K080812 · Beckman Coulter, Inc. · Jun 2008
FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE)
K073431 · Tianjin New Bay Bioresearch Co., Ltd. · Jan 2008
INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
K070660 · Alfa Scientific Designs, Inc. · Jun 2007
FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST
K063693 · New Bay Bioresearch Co. , Ltd. · May 2007
K071242 · DBEST ONE STEP OCCULT BLOOD TEST KITS
Download PDF Ameritek USA, Inc.