Cleared Traditional

K821884 - GASTROCCULT TM

K821884 is the FDA 510(k) clearance for GASTROCCULT TM by Smithkline Diagnostics, Inc.. It is a Class 2 Hematology device (product code KHE) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K821884 · Smithkline Diagnostics, Inc. · Hematology device
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Oct 1982
Decision
105d
Days
Class 2
Risk

K821884 is an FDA 510(k) clearance for the GASTROCCULT TM. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Smithkline Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 8, 1982 after a review of 105 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 K821884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1982
Decision Date October 08, 1982
Days to Decision 105 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
8d faster than avg
Panel avg: 113d · This submission: 105d
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 K821884.
EARLY DETECTOR
K833369 · Warner-Lambert Co. · Aug 1984
HELENA BIO STRIP OB
K834456 · Helena Laboratories · Jan 1984
COLOSCREEN V.P.I.
K832864 · Helena Laboratories · Nov 1983
HELENA COLOSCREEN METHOD
K812428 · Helena Laboratories · Oct 1981
HELENA COLOCHECK
K800433 · Helena Laboratories · May 1980
HELENA COLOSCREEN
K792655 · Helena Laboratories · Jan 1980