Cleared Traditional

K052598 - IMMOCARE

K052598 is an FDA 510(k) clearance for IMMOCARE, manufactured by Care Diagnostic, Inc.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K052598 · Care Diagnostic, Inc. · Hematology device
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Mar 2006
Decision
176d
Days
Class 2
Risk

K052598 is an FDA 510(k) clearance for the IMMOCARE. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Care Diagnostic, Inc. (Klamath Falls, US). The FDA issued a Cleared decision on March 16, 2006 after a review of 176 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 Care Diagnostic, Inc. devices

FDA 510(k) Submission Details - K052598

510(k) Number K052598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2005
Decision Date March 16, 2006
Days to Decision 176 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 113d · This submission: 176d
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 K052598.
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
CARE FECAL OCCULT BLOOD TEST, MODEL KT313
K051806 · Epitope Diagnostics, Inc. · Oct 2005
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