Cleared Traditional

K861731 - NATURAL DETECTOR SYSTEM

K861731 is an FDA 510(k) clearance for NATURAL DETECTOR SYSTEM, manufactured by U.S. Health Resources Corp.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K861731 · U.S. Health Resources Corp. · Hematology device
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Nov 1986
Decision
184d
Days
Class 2
Risk

K861731 is an FDA 510(k) clearance for the NATURAL DETECTOR SYSTEM. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by U.S. Health Resources Corp. (Miami, US). The FDA issued a Cleared decision on November 6, 1986 after a review of 184 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.

FDA 510(k) Submission Details - K861731

510(k) Number K861731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1986
Decision Date November 06, 1986
Days to Decision 184 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
71d slower than avg
Panel avg: 113d · This submission: 184d
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 K861731.
REVISED IMMUDIA HEM-SP
K874482 · Schiff & Co. · May 1988
WAKO(TM) PRETEST 6A
K873409 · Wako Chemicals USA, Inc. · Feb 1988
HEMOCCULT WIPE TEST
K862849 · Smithkline Diagnostics, Inc. · Dec 1986
BIOTEL (TM)/ KIDNEY
K855237 · American Diagnostic Corp. · May 1986
EZ DETECH-URINE BLOOD TEST STICKS
K854358 · Self Care Systems, Inc. · Apr 1986
MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL
K860028 · Self Care Systems, Inc. · Apr 1986
K861731 · NATURAL DETECTOR SYSTEM
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