Cleared Traditional

K830919 - OCCULT-ALERT

K830919 is the FDA 510(k) clearance for OCCULT-ALERT by Beta Med Pharmaceuticals, Inc.. It is a Class 2 Chemistry device (product code KHE) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K830919 · Beta Med Pharmaceuticals, Inc. · Chemistry device
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Jul 1983
Decision
107d
Days
Class 2
Risk

K830919 is an FDA 510(k) clearance for the OCCULT-ALERT. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Beta Med Pharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 7, 1983 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.6550 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Beta Med Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K830919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1983
Decision Date July 07, 1983
Days to Decision 107 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 88d · This submission: 107d
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 Chemistry devices follow this clearance model.

Regulatory Peers - KHE Reagent, Occult Blood

All 30
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K830919.
EARLY DETECTOR
K833369 · Warner-Lambert Co. · Aug 1984
HELENA BIO STRIP OB
K834456 · Helena Laboratories · Jan 1984
COLOSCREEN V.P.I.
K832864 · Helena Laboratories · Nov 1983
GASTROCCULT TM
K821884 · Smithkline Diagnostics, Inc. · Oct 1982
UROPAPER EIKEG
K811815 · Syn-Kit, Inc. · Dec 1981
HELENA COLOSCREEN METHOD
K812428 · Helena Laboratories · Oct 1981