Cleared Traditional

K883432 - IMMUNOCCULT-LXI

K883432 is an FDA 510(k) clearance for IMMUNOCCULT-LXI, 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 77-day FDA review.

K883432 · Intl. Immunoassay Laboratories, Inc. · Hematology device
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Oct 1988
Decision
77d
Days
Class 2
Risk

K883432 is an FDA 510(k) clearance for the IMMUNOCCULT-LXI. 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 October 31, 1988 after a review of 77 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 Intl. Immunoassay Laboratories, Inc. devices

FDA 510(k) Submission Details - K883432

510(k) Number K883432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1988
Decision Date October 31, 1988
Days to Decision 77 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
36d faster than avg
Panel avg: 113d · This submission: 77d
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 55
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K883432.
COLOSCREEN
K911075 · Helena Laboratories · Jul 1991
RESUBMITTED FECATWIN SENSITIVE - FECA-EIA
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HEMAWIPE SYSTEM, THE CIVILIZED TEST
K884206 · Labeltape Meditect, Inc. · Apr 1989
HELENA COLOCARE
K882799 · Helena Laboratories · Sep 1988
IMMUNOCCULT EIA TEST KIT
K871143 · Intl. Immunoassay Laboratories, Inc. · Jul 1988
HEMOCCULT SENSITIVE TEST
K880499 · Smithkline Diagnostics, Inc. · May 1988