Cleared Traditional

K002930 - INSTACCULT

K002930 is the FDA 510(k) clearance for INSTACCULT by Medtek Diagnostics, LLC. It is a Class 2 Hematology device (product code KHE) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K002930 · Medtek Diagnostics, LLC · Hematology device
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Jan 2001
Decision
124d
Days
Class 2
Risk

K002930 is an FDA 510(k) clearance for the INSTACCULT. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Medtek Diagnostics, LLC (Research Triangle Park, US). The FDA issued a Cleared decision on January 22, 2001 after a review of 124 days - within the typical 510(k) review window.

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 Medtek Diagnostics, LLC devices

Submission Details

510(k) Number K002930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2000
Decision Date January 22, 2001
Days to Decision 124 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 113d · This submission: 124d
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 28
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K002930.
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
INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
K021423 · Alfa Scientific Designs, Inc. · Jun 2002
COLOSCREEN-ES
K003359 · Helena Laboratories · Nov 2000
COLOSCREEN-ES
K980671 · Helena Laboratories · May 1998
FLEXSURE OBT
K961062 · Smithkline Diagnostics, Inc. · Nov 1996