Cleared Traditional

K862849 - HEMOCCULT WIPE TEST

K862849 is the FDA 510(k) clearance for HEMOCCULT WIPE TEST by Smithkline Diagnostics, Inc.. It is a Class 2 Hematology device (product code KHE) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K862849 · Smithkline Diagnostics, Inc. · Hematology device
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Dec 1986
Decision
133d
Days
Class 2
Risk

K862849 is an FDA 510(k) clearance for the HEMOCCULT WIPE TEST. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Smithkline Diagnostics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 9, 1986 after a review of 133 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.

View all Smithkline Diagnostics, Inc. devices

Submission Details

510(k) Number K862849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1986
Decision Date December 09, 1986
Days to Decision 133 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
20d slower than avg
Panel avg: 113d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K862849.
HELENA COLOCARE
K882799 · Helena Laboratories · Sep 1988
HEMOCCULT SENSITIVE TEST
K880499 · Smithkline Diagnostics, Inc. · May 1988
WAKO(TM) PRETEST 6A
K873409 · Wako Chemicals USA, Inc. · Feb 1988
BIOTEL (TM)/ KIDNEY
K855237 · American Diagnostic Corp. · May 1986
COLOSCREEN SELF-TEST
K843352 · Helena Laboratories · Dec 1984
HELENA COLOSCREEN SELF-TEST
K840903 · Helena Laboratories · Aug 1984