Cleared Traditional

K830919 - OCCULT-ALERT

K830919 is an FDA 510(k) clearance for OCCULT-ALERT, manufactured by Beta Med Pharmaceuticals, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K830919

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.

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 Chemistry devices follow this clearance model.

Regulatory Peers - KHE Reagent, Occult Blood

All 62
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K830919.
PROPPER SERACULT
K834297 · Propper Mfg. Co., Inc. · Jan 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
FE-CULT PLUS
K820072 · Gamma Biologicals, Inc. · Mar 1982
SERACULT OCCULT BLOOF TEST
K813204 · Propper Mfg. Co., Inc. · Jan 1982