Cleared Traditional

K862849 - HEMOCCULT WIPE TEST

K862849 is an FDA 510(k) clearance for HEMOCCULT WIPE TEST, manufactured by Smithkline Diagnostics, Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K862849

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.

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 K862849.
IMMUNOCCULT EIA TEST KIT
K871143 · Intl. Immunoassay Laboratories, Inc. · Jul 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
UROPAPER EIKEN 8
K843532 · Syn-Kit, Inc. · Dec 1984
COLOSCREEN SELF-TEST
K843352 · Helena Laboratories · Dec 1984