Cleared Traditional

K143325 - OC-Light S FIT

K143325 is an FDA 510(k) clearance for OC-Light S FIT, manufactured by Eiken Chemical Co., Ltd.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K143325

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.

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.

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All 50
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