Cleared Traditional

K780564 - FECATEST

K780564 is the FDA 510(k) clearance for FECATEST by Otto C. Watzka. It is a Class 2 Hematology device (product code KHE) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K780564 · Otto C. Watzka · Hematology device
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Jun 1978
Decision
85d
Days
Class 2
Risk

K780564 is an FDA 510(k) clearance for the FECATEST. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Otto C. Watzka (Mchenry, US). The FDA issued a Cleared decision on June 30, 1978 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Otto C. Watzka devices

Submission Details

510(k) Number K780564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1978
Decision Date June 30, 1978
Days to Decision 85 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 113d · This submission: 85d
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.