Cleared Traditional

K961062 - FLEXSURE OBT

K961062 is an FDA 510(k) clearance for FLEXSURE OBT, manufactured by Smithkline Diagnostics, Inc.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K961062 · Smithkline Diagnostics, Inc. · Hematology device
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Nov 1996
Decision
233d
Days
Class 2
Risk

K961062 is an FDA 510(k) clearance for the FLEXSURE OBT. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Smithkline Diagnostics, Inc. (Sharon Hill, US). The FDA issued a Cleared decision on November 6, 1996 after a review of 233 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 Smithkline Diagnostics, Inc. devices

FDA 510(k) Submission Details - K961062

510(k) Number K961062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1996
Decision Date November 06, 1996
Days to Decision 233 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
120d slower than avg
Panel avg: 113d · This submission: 233d
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 54
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K961062.
HEMAPROMPT
K981661 · Aerscher Diagnostics · Sep 1998
COLOSCREEN-ES
K980671 · Helena Laboratories · May 1998
HEMAPROMPT
K972763 · Aerscher Diagnostics · Oct 1997
PROPPER SUPER SERACULT(R)
K921798 · Propper Mfg. Co., Inc. · Oct 1992
HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION
K912979 · Labeltape Meditect, Inc. · Oct 1991
COLOCARE
K905798 · Helena Laboratories · Jul 1991