Cleared Traditional

K874180 - COLORECTAL CANCER RISK DETECTOR (TM)

K874180 is the FDA 510(k) clearance for COLORECTAL CANCER RISK DETECTOR (TM) by Pearce Clinical Laboratories, Inc.. It is a Class 2 Hematology device (product code KHE) cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K874180 · Pearce Clinical Laboratories, Inc. · Hematology device
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Sep 1988
Decision
352d
Days
Class 2
Risk

K874180 is an FDA 510(k) clearance for the COLORECTAL CANCER RISK DETECTOR (TM). Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Pearce Clinical Laboratories, Inc. (Conroe, US). The FDA issued a Cleared decision on September 30, 1988 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Pearce Clinical Laboratories, Inc. devices

Submission Details

510(k) Number K874180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1987
Decision Date September 30, 1988
Days to Decision 352 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
239d slower than avg
Panel avg: 113d · This submission: 352d
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 30
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K874180.
FLEXSURE OBT
K961062 · Smithkline Diagnostics, Inc. · Nov 1996
COLOCARE
K905798 · Helena Laboratories · Jul 1991
COLOSCREEN
K911075 · Helena Laboratories · Jul 1991
HELENA COLOCARE
K882799 · Helena Laboratories · Sep 1988
HEMOCCULT SENSITIVE TEST
K880499 · Smithkline Diagnostics, Inc. · May 1988
WAKO(TM) PRETEST 6A
K873409 · Wako Chemicals USA, Inc. · Feb 1988