Cleared Traditional

K980671 - COLOSCREEN-ES

K980671 is an FDA 510(k) clearance for COLOSCREEN-ES, manufactured by Helena Laboratories. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K980671 · Helena Laboratories · Hematology device
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May 1998
Decision
81d
Days
Class 2
Risk

K980671 is an FDA 510(k) clearance for the COLOSCREEN-ES. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on May 12, 1998 after a review of 81 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 Helena Laboratories devices

FDA 510(k) Submission Details - K980671

510(k) Number K980671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1998
Decision Date May 12, 1998
Days to Decision 81 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 113d · This submission: 81d
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 Hematology devices follow this clearance model.

Regulatory Peers - KHE Reagent, Occult Blood

All 53
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K980671.
COLON ALERT TEST
K992759 · Immunostics Inc., · Dec 1999
DBEST OCCULT BLOOD TEST KIT
K984269 · Ameritek, Inc. · May 1999
HEMAPROMPT
K981661 · Aerscher Diagnostics · Sep 1998
HEMAPROMPT
K972763 · Aerscher Diagnostics · Oct 1997
FLEXSURE OBT
K961062 · Smithkline Diagnostics, Inc. · Nov 1996
PROPPER SUPER SERACULT(R)
K921798 · Propper Mfg. Co., Inc. · Oct 1992