Cleared Traditional

K880499 - HEMOCCULT SENSITIVE TEST

K880499 is the FDA 510(k) clearance for HEMOCCULT SENSITIVE TEST by Smithkline Diagnostics, Inc.. It is a Class 2 Hematology device (product code KHE) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K880499 · Smithkline Diagnostics, Inc. · Hematology device
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May 1988
Decision
108d
Days
Class 2
Risk

K880499 is an FDA 510(k) clearance for the HEMOCCULT SENSITIVE TEST. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Smithkline Diagnostics, Inc. (San Jose, US). The FDA issued a Cleared decision on May 23, 1988 after a review of 108 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 K880499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1988
Decision Date May 23, 1988
Days to Decision 108 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
5d faster than avg
Panel avg: 113d · This submission: 108d
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 K880499.
COLOCARE
K905798 · Helena Laboratories · Jul 1991
COLOSCREEN
K911075 · Helena Laboratories · Jul 1991
HELENA COLOCARE
K882799 · Helena Laboratories · Sep 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