Cleared Traditional

K821884 - GASTROCCULT TM

K821884 is an FDA 510(k) clearance for GASTROCCULT TM, 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 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

FDA 510(k) Submission Details - K821884

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.

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 K821884.
PROPPER SERACULT
K834297 · Propper Mfg. Co., Inc. · Jan 1984
HELENA BIO STRIP OB
K834456 · Helena Laboratories · Jan 1984
COLOSCREEN V.P.I.
K832864 · Helena Laboratories · Nov 1983
FE-CULT PLUS
K820072 · Gamma Biologicals, Inc. · Mar 1982
SERACULT OCCULT BLOOF TEST
K813204 · Propper Mfg. Co., Inc. · Jan 1982
UROPAPER EIKEG
K811815 · Syn-Kit, Inc. · Dec 1981