Cleared Traditional

K143325 - OC-Light S FIT

K143325 is the FDA 510(k) clearance for OC-Light S FIT by Eiken Chemical Co., Ltd.. It is a Class 2 Hematology device (product code KHE) cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K143325 · Eiken Chemical Co., Ltd. · Hematology device
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Aug 2015
Decision
273d
Days
Class 2
Risk

K143325 is an FDA 510(k) clearance for the OC-Light S FIT. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Eiken Chemical Co., Ltd. (Taito-Ku, JP). The FDA issued a Cleared decision on August 20, 2015 after a review of 273 days - an extended review 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: 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 Eiken Chemical Co., Ltd. devices

Submission Details

510(k) Number K143325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2014
Decision Date August 20, 2015
Days to Decision 273 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 113d · This submission: 273d
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 K143325.
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BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
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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