Cleared Traditional

K041297 - POLYMEDCO OC LIGHT FOBT TEST

K041297 is the FDA 510(k) clearance for POLYMEDCO OC LIGHT FOBT TEST by Polymedco, Inc.. It is a Class 2 Hematology device (product code KHE) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K041297 · Polymedco, Inc. · Hematology device
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Aug 2004
Decision
90d
Days
Class 2
Risk

K041297 is an FDA 510(k) clearance for the POLYMEDCO OC LIGHT FOBT TEST. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on August 12, 2004 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Polymedco, Inc. devices

Submission Details

510(k) Number K041297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2004
Decision Date August 12, 2004
Days to Decision 90 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 113d · This submission: 90d
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.

Regulatory Peers - KHE Reagent, Occult Blood

All 21
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K041297.
BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
K100817 · Princeton BioMeditech Corp. · Jul 2010
HEMOCCULT ICT
K080812 · Beckman Coulter, Inc. · Jun 2008
FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
K061065 · Teco Diagnostics · Jul 2006
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
K033548 · Roche Diagnostics Corp. · Nov 2003
COLOSCREEN-ES
K003359 · Helena Laboratories · Nov 2000
COLOSCREEN-ES
K980671 · Helena Laboratories · May 1998