Cleared Traditional

HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES (K936056) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K936056 · Dipro Diagnostic Products GmbH · Hematology device
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Apr 1995
Decision
471d
Days
Class 2
Risk

K936056 is an FDA 510(k) clearance for the HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Dipro Diagnostic Products GmbH (Mamaroneck, US). The FDA issued a Cleared decision on April 5, 1995 after a review of 471 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Dipro Diagnostic Products GmbH devices

Submission Details

510(k) Number K936056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1993
Decision Date April 05, 1995
Days to Decision 471 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
358d slower than avg
Panel avg: 113d · This submission: 471d
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 96
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K936056.
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COLOSCREEN-ES
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COLOSCREEN-ES
K980671 · Helena Laboratories · May 1998