Cleared Traditional

K854619 - DETECTACULT

K854619 is an FDA 510(k) clearance for DETECTACULT, manufactured by Immunostics Co., Inc.. The device is a Class 2 Microbiology device with product code KHE cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K854619 · Immunostics Co., Inc. · Microbiology device
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Mar 1986
Decision
105d
Days
Class 2
Risk

K854619 is an FDA 510(k) clearance for the DETECTACULT. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Immunostics Co., Inc. (Metuchen, US). The FDA issued a Cleared decision on March 3, 1986 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.6550 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Immunostics Co., Inc. devices

FDA 510(k) Submission Details - K854619

510(k) Number K854619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1985
Decision Date March 03, 1986
Days to Decision 105 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 102d · This submission: 105d
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 Microbiology devices follow this clearance model.

Regulatory Peers - KHE Reagent, Occult Blood

All 62
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K854619.
WAKO(TM) PRETEST 6A
K873409 · Wako Chemicals USA, Inc. · Feb 1988
HEMOCCULT WIPE TEST
K862849 · Smithkline Diagnostics, Inc. · Dec 1986
BIOTEL (TM)/ KIDNEY
K855237 · American Diagnostic Corp. · May 1986
UROPAPER EIKEN 8
K843532 · Syn-Kit, Inc. · Dec 1984
COLOSCREEN SELF-TEST
K843352 · Helena Laboratories · Dec 1984
HELENA COLOSCREEN SELF-TEST
K840903 · Helena Laboratories · Aug 1984