Cleared Traditional

K843352 - COLOSCREEN SELF-TEST

K843352 is an FDA 510(k) clearance for COLOSCREEN SELF-TEST, manufactured by Helena Laboratories. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K843352 · Helena Laboratories · Hematology device
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Dec 1984
Decision
100d
Days
Class 2
Risk

K843352 is an FDA 510(k) clearance for the COLOSCREEN SELF-TEST. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on December 5, 1984 after a review of 100 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.

FDA 510(k) Submission Details - K843352

510(k) Number K843352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1984
Decision Date December 05, 1984
Days to Decision 100 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
13d faster than avg
Panel avg: 113d · This submission: 100d
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 96
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K843352.
EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL
K850431 · Nms Pharmaceuticals, Inc. · Jun 1985
ACCESS HEMAWIPE
K843601 · Medtech Products, Inc. · Jan 1985
UROPAPER EIKEN 8
K843532 · Syn-Kit, Inc. · Dec 1984
COLOTRAK OCCULT BLOOD TEST
K840527 · Breit Laboratories, Inc. · Sep 1984
OCCULT BLOOD TEST
K842137 · Breit Laboratories, Inc. · Sep 1984
ACCU-CULT FECAL OCCULT BLOOD TEST
K840904 · Applied Medical Devices, Inc. · Aug 1984
K843352 · COLOSCREEN SELF-TEST
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