Cleared Traditional

K840904 - ACCU-CULT FECAL OCCULT BLOOD TEST (FDA 510(k) Clearance)

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

K840904 · Applied Medical Devices, Inc. · Hematology device
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Aug 1984
Decision
170d
Days
Class 2
Risk

K840904 is an FDA 510(k) clearance for the ACCU-CULT FECAL OCCULT BLOOD TEST. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Applied Medical Devices, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1984 after a review of 170 days - an extended review cycle.

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 Applied Medical Devices, Inc. devices

Submission Details

510(k) Number K840904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1984
Decision Date August 16, 1984
Days to Decision 170 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 113d · This submission: 170d
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.