Cleared Traditional

K041297 - POLYMEDCO OC LIGHT FOBT TEST

K041297 is an FDA 510(k) clearance for POLYMEDCO OC LIGHT FOBT TEST, manufactured by Polymedco, Inc.. The device is a Class 2 Hematology device with 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.

FDA 510(k) Submission Details - K041297

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
Combination Product No
PCCP Authorized No
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.

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 84
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K041297.
IMMOCARE
K052598 · Care Diagnostic, Inc. · Mar 2006
CARE FECAL OCCULT BLOOD TEST, MODEL KT313
K051806 · Epitope Diagnostics, Inc. · Oct 2005
HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST
K041202 · W.H.P.M., Inc. · Aug 2004
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
K033548 · Roche Diagnostics Corp. · Nov 2003
HEMAPROMPT GASTRIC
K031356 · Aerscher Diagnostics · Sep 2003
COLONCARE
K030216 · Care Products, Inc. · Apr 2003
K041297 · POLYMEDCO OC LIGHT FOBT TEST
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