Cleared Traditional

K981661 - HEMAPROMPT

K981661 is an FDA 510(k) clearance for HEMAPROMPT, manufactured by Aerscher Diagnostics. The device is a Class 2 Hematology device with product code KHE cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K981661 · Aerscher Diagnostics · Hematology device
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Sep 1998
Decision
132d
Days
Class 2
Risk

K981661 is an FDA 510(k) clearance for the HEMAPROMPT. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Aerscher Diagnostics (Chestertown, US). The FDA issued a Cleared decision on September 15, 1998 after a review of 132 days - within the typical 510(k) review window.

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 Aerscher Diagnostics devices

FDA 510(k) Submission Details - K981661

510(k) Number K981661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1998
Decision Date September 15, 1998
Days to Decision 132 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 113d · This submission: 132d
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 53
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K981661.
COLOSCREEN-ES
K003359 · Helena Laboratories · Nov 2000
COLON ALERT TEST
K992759 · Immunostics Inc., · Dec 1999
DBEST OCCULT BLOOD TEST KIT
K984269 · Ameritek, Inc. · May 1999
COLOSCREEN-ES
K980671 · Helena Laboratories · May 1998
HEMAPROMPT
K972763 · Aerscher Diagnostics · Oct 1997
FLEXSURE OBT
K961062 · Smithkline Diagnostics, Inc. · Nov 1996