Cleared Traditional

K860028 - MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL

K860028 is an FDA 510(k) clearance for MODIFIED EZ DETECT OCCULT BLOOD TEST IN..., manufactured by Self Care Systems, Inc.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K860028 · Self Care Systems, Inc. · Hematology device
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Apr 1986
Decision
94d
Days
Class 2
Risk

K860028 is an FDA 510(k) clearance for the MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Self Care Systems, Inc. (Newport Beach, US). The FDA issued a Cleared decision on April 7, 1986 after a review of 94 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 - K860028

510(k) Number K860028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1986
Decision Date April 07, 1986
Days to Decision 94 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 113d · This submission: 94d
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 K860028.
NATURAL DETECTOR SYSTEM
K861731 · U.S. Health Resources Corp. · Nov 1986
BIOTEL (TM)/ KIDNEY
K855237 · American Diagnostic Corp. · May 1986
EZ DETECH-URINE BLOOD TEST STICKS
K854358 · Self Care Systems, Inc. · Apr 1986
DETECTACULT
K854619 · Immunostics Co., Inc. · Mar 1986
ACCESS DIGIWIPE SYSTEM
K853141 · Medtech Products, Inc. · Nov 1985
EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL
K850431 · Nms Pharmaceuticals, Inc. · Jun 1985
K860028 · MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL
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