Cleared Traditional

K030216 - COLONCARE

K030216 is an FDA 510(k) clearance for COLONCARE, manufactured by Care Products, Inc.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K030216 · Care Products, Inc. · Hematology device
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Apr 2003
Decision
71d
Days
Class 2
Risk

K030216 is an FDA 510(k) clearance for the COLONCARE. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Care Products, Inc. (Waterbury, US). The FDA issued a Cleared decision on April 2, 2003 after a review of 71 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 Care Products, Inc. devices

FDA 510(k) Submission Details - K030216

510(k) Number K030216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2003
Decision Date April 02, 2003
Days to Decision 71 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
42d faster than avg
Panel avg: 113d · This submission: 71d
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 61
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K030216.
HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST
K041202 · W.H.P.M., Inc. · Aug 2004
POLYMEDCO OC LIGHT FOBT TEST
K041297 · Polymedco, Inc. · Aug 2004
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
COLON ALERT TEST
K992759 · Immunostics Inc., · Dec 1999