Cleared Traditional

K984269 - DBEST OCCULT BLOOD TEST KIT

K984269 is an FDA 510(k) clearance for DBEST OCCULT BLOOD TEST KIT, manufactured by Ameritek, Inc.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K984269 · Ameritek, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
201d
Days
Class 2
Risk

K984269 is an FDA 510(k) clearance for the DBEST OCCULT BLOOD TEST KIT. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Ameritek, Inc. (Seattle, US). The FDA issued a Cleared decision on May 11, 1999 after a review of 201 days - an extended review cycle.

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 Ameritek, Inc. devices

FDA 510(k) Submission Details - K984269

510(k) Number K984269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1998
Decision Date May 11, 1999
Days to Decision 201 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
88d slower than avg
Panel avg: 113d · This submission: 201d
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 53
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K984269.
INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
K021423 · Alfa Scientific Designs, Inc. · Jun 2002
COLOSCREEN-ES
K003359 · Helena Laboratories · Nov 2000
COLON ALERT TEST
K992759 · Immunostics Inc., · Dec 1999
HEMAPROMPT
K981661 · Aerscher Diagnostics · Sep 1998
COLOSCREEN-ES
K980671 · Helena Laboratories · May 1998
HEMAPROMPT
K972763 · Aerscher Diagnostics · Oct 1997