Cleared Traditional

K060953 - OCCULTECH FECAL OCCULT BLOOD RAPID TEST

K060953 is an FDA 510(k) clearance for OCCULTECH FECAL OCCULT BLOOD RAPID TEST, manufactured by Yd Diagnostics Corp.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K060953 · Yd Diagnostics Corp. · Hematology device
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Sep 2006
Decision
165d
Days
Class 2
Risk

K060953 is an FDA 510(k) clearance for the OCCULTECH FECAL OCCULT BLOOD RAPID TEST. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Yd Diagnostics Corp. (Annandale, US). The FDA issued a Cleared decision on September 18, 2006 after a review of 165 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 Yd Diagnostics Corp. devices

FDA 510(k) Submission Details - K060953

510(k) Number K060953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2006
Decision Date September 18, 2006
Days to Decision 165 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 113d · This submission: 165d
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 60
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K060953.
INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
K070660 · Alfa Scientific Designs, Inc. · Jun 2007
FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST
K063693 · New Bay Bioresearch Co. , Ltd. · May 2007
INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE
K063673 · Innovacon, Inc. · Mar 2007
FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
K061065 · Teco Diagnostics · Jul 2006
HEMA SCREEN SPECIFIC IFOBT
K060463 · Immunostics Inc., · Jun 2006
INSURE II
K060930 · Enterix, Inc. · May 2006