Cleared Traditional

K871143 - IMMUNOCCULT EIA TEST KIT

K871143 is an FDA 510(k) clearance for IMMUNOCCULT EIA TEST KIT, manufactured by Intl. Immunoassay Laboratories, Inc.. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 473-day FDA review.

K871143 · Intl. Immunoassay Laboratories, Inc. · Hematology device
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Jul 1988
Decision
473d
Days
Class 2
Risk

K871143 is an FDA 510(k) clearance for the IMMUNOCCULT EIA TEST KIT. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Intl. Immunoassay Laboratories, Inc. (Santa Clara, US). The FDA issued a Cleared decision on July 8, 1988 after a review of 473 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

FDA 510(k) Submission Details - K871143

510(k) Number K871143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1987
Decision Date July 08, 1988
Days to Decision 473 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
360d slower than avg
Panel avg: 113d · This submission: 473d
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 96
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K871143.
IMMUNOCCULT-LXI
K883432 · Intl. Immunoassay Laboratories, Inc. · Oct 1988
COLORECTAL CANCER RISK DETECTOR (TM)
K874180 · Pearce Clinical Laboratories, Inc. · Sep 1988
HELENA COLOCARE
K882799 · Helena Laboratories · Sep 1988
HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD
K881907 · Enzo Biochem, Inc. · Jul 1988
HEMOCCULT SENSITIVE TEST
K880499 · Smithkline Diagnostics, Inc. · May 1988
REVISED IMMUDIA HEM-SP
K874482 · Schiff & Co. · May 1988
K871143 · IMMUNOCCULT EIA TEST KIT
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