Cleared Traditional

K061065 - FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25

K061065 is an FDA 510(k) clearance for FECAL OCCULT BLOOD CARD TEST, manufactured by Teco Diagnostics. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K061065 · Teco Diagnostics · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
88d
Days
Class 2
Risk

K061065 is an FDA 510(k) clearance for the FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODE.... Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on July 14, 2006 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Teco Diagnostics devices

FDA 510(k) Submission Details - K061065

510(k) Number K061065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2006
Decision Date July 14, 2006
Days to Decision 88 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
25d faster than avg
Panel avg: 113d · This submission: 88d
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 70
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K061065.
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
OCCULTECH FECAL OCCULT BLOOD RAPID TEST
K060953 · Yd Diagnostics Corp. · Sep 2006
HEMA SCREEN SPECIFIC IFOBT
K060463 · Immunostics Inc., · Jun 2006
INSURE II
K060930 · Enterix, Inc. · May 2006
IMMOCARE
K052598 · Care Diagnostic, Inc. · Mar 2006