Cleared Traditional

K834456 - HELENA BIO STRIP OB

K834456 is an FDA 510(k) clearance for HELENA BIO STRIP OB, manufactured by Helena Laboratories. The device is a Class 2 Chemistry device with product code KHE cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K834456 · Helena Laboratories · Chemistry device
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Jan 1984
Decision
25d
Days
Class 2
Risk

K834456 is an FDA 510(k) clearance for the HELENA BIO STRIP OB. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Helena Laboratories (Walker, US). The FDA issued a Cleared decision on January 13, 1984 after a review of 25 days - a notably fast clearance cycle.

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: 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 Helena Laboratories devices

FDA 510(k) Submission Details - K834456

510(k) Number K834456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1983
Decision Date January 13, 1984
Days to Decision 25 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 88d · This submission: 25d
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 54
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K834456.
HELENA COLOSCREEN SELF-TEST
K840903 · Helena Laboratories · Aug 1984
EARLY DETECTOR
K833369 · Warner-Lambert Co. · Aug 1984
PROPPER SERACULT
K834297 · Propper Mfg. Co., Inc. · 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